Supplemental Evidence and Data Request on Dietary Total Fat Intake and Dietary Polyunsaturated Fatty Acid Intake and Child Growth and Development Outcomes: A Systematic Review, 90695-90698 [2024-26783]
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Federal Register / Vol. 89, No. 222 / Monday, November 18, 2024 / Notices
Print submissions:
Mailing Address: Center for Evidence
Blanchard, Mary Josie, Deputy Director,
and Practice Improvement, Agency for
Environmental Protection
Healthcare Research and Quality,
Compliance, MaryJosie_Blanchard@
ATTN: EPC SEADs Coordinator, 5600
ios.doi.gov, 202–208–3406
Fishers Lane, Mail Stop 06E53A,
State of Florida
Rockville, MD 20857.
Shipping Address (FedEx, UPS, etc.):
Blalock, Adam, Deputy Secretary for
Center for Evidence and Practice
Ecosystem Restoration,
Improvement, Agency for Healthcare
Adam.Blalock@floridadep.gov, 850–
Research and Quality, ATTN: EPC
245–2118
SEADs Coordinator, 5600 Fishers Lane,
State of Alabama
Mail Stop 06E77D, Rockville, MD
20857.
Blankenship, Chris, Commissioner,
Alabama Department of Conservation FOR FURTHER INFORMATION CONTACT:
and Natural Resources,
Kelly Carper, Telephone: 301–427–1656
Chris.blankenship@dcnr.alabama.gov, or Email: epc@ahrq.hhs.gov.
334–242–3486
SUPPLEMENTARY INFORMATION: The
Agency for Healthcare Research and
Environmental Protection Agency
Quality has commissioned the
Wyatt, Marc, Director, Gulf of Mexico
Evidence-based Practice Centers (EPC)
Division, Wyatt.marc@epa.gov, 228–
Program to complete a review of the
679–5915
evidence for Dietary Total Fat Intake
and Dietary Polyunsaturated Fatty Acid
Keala J. Hughes,
Director of External Affairs & Tribal Relations, Intake and Child Growth and
Development Outcomes: A Systematic
Gulf Coast Ecosystem Restoration Council.
Review. AHRQ is conducting this
[FR Doc. 2024–26818 Filed 11–15–24; 8:45 am]
review pursuant to Section 902 of the
BILLING CODE 6560–58–P
Public Health Service Act, 42 U.S.C.
299a.
The EPC Program is dedicated to
DEPARTMENT OF HEALTH AND
identifying
as many studies as possible
HUMAN SERVICES
that are relevant to the questions for
each of its reviews. In order to do so, we
Agency for Healthcare Research and
are supplementing the usual manual
Quality
and electronic database searches of the
Supplemental Evidence and Data
literature by requesting information
Request on Dietary Total Fat Intake
from the public (e.g., details of studies
and Dietary Polyunsaturated Fatty Acid conducted). We are looking for studies
Intake and Child Growth and
that report on Dietary Total Fat Intake
Development Outcomes: A Systematic and Dietary Polyunsaturated Fatty Acid
Review
Intake and Child Growth and
Development Outcomes: A Systematic
AGENCY: Agency for Healthcare Research
Review. The entire research protocol is
and Quality (AHRQ), HHS.
available online at: https://
ACTION: Request for supplemental
effectivehealthcare.ahrq.gov/products/
evidence and data submission.
child-growth-development-outcomes/
protocol.
SUMMARY: The Agency for Healthcare
This is to notify the public that the
Research and Quality (AHRQ) is seeking
EPC Program would find the following
scientific information submissions from
information on Dietary Total Fat Intake
the public. Scientific information is
and Dietary Polyunsaturated Fatty Acid
being solicited to inform our review on
Intake and Child Growth and
Dietary Total Fat Intake and Dietary
Development Outcomes: A Systematic
Polyunsaturated Fatty Acid Intake and
Review helpful:
Child Growth and Development
D A list of completed studies that
Outcomes: A Systematic Review, which your organization has sponsored for this
is currently being conducted by the
topic. In the list, please indicate
AHRQ’s Evidence-based Practice
whether results are available on
Centers (EPC) Program. Access to
ClinicalTrials.gov along with the
published and unpublished pertinent
ClinicalTrials.gov trial number.
scientific information will improve the
D For completed studies that do not
quality of this review.
have results on ClinicalTrials.gov, a
DATES: Submission Deadline on or
summary, including the following
before December 18, 2024.
elements, if relevant: study number,
study period, design, methodology,
ADDRESSES:
indication and diagnosis, proper use
Email submissions: epc@
instructions, inclusion and exclusion
ahrq.hhs.gov.
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90695
criteria, primary and secondary
outcomes, baseline characteristics,
number of patients screened/eligible/
enrolled/lost to follow-up/withdrawn/
analyzed, effectiveness/efficacy, and
safety results.
D A list of ongoing studies that your
organization has sponsored for this
topic. In the list, please provide the
ClinicalTrials.gov trial number or, if the
trial is not registered, the protocol for
the study including, if relevant, a study
number, the study period, design,
methodology, indication and diagnosis,
proper use instructions, inclusion and
exclusion criteria, and primary and
secondary outcomes.
D Description of whether the above
studies constitute ALL Phase II and
above clinical trials sponsored by your
organization for this topic and an index
outlining the relevant information in
each submitted file.
Your contribution is very beneficial to
the Program. Materials submitted must
be publicly available or able to be made
public. Materials that are considered
confidential; marketing materials; study
types not included in the review; or
information on topics not included in
the review cannot be used by the EPC
Program. This is a voluntary request for
information, and all costs for complying
with this request must be borne by the
submitter.
The draft of this review will be posted
on AHRQ’s EPC Program website and
available for public comment for a
period of 4 weeks. If you would like to
be notified when the draft is posted,
please sign up for the email list at:
https://effectivehealthcare.ahrq.gov/
email-updates.
The review will answer the following
questions. This information is provided
as background. AHRQ is not requesting
that the public provide answers to these
questions.
Key Questions (KQ)
KQ 1: What is the association between
dietary intake of omega-6 and/or omega3 polyunsaturated fatty acids during
pregnancy and risk of preterm birth?
KQ 1a: How are these associations
affected by intervention/exposure
characteristics (for example, the ratio of
different fatty acids)?
KQ 2: What is the association between
dietary intake of omega-6 and/or omega3 polyunsaturated fatty acids during
pregnancy and/or lactation and infant/
child growth and developmental
outcomes?
KQ 2a: How are these associations
affected by intervention/exposure
characteristics (for example, the ratio of
different fatty acids)?
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90696
Federal Register / Vol. 89, No. 222 / Monday, November 18, 2024 / Notices
KQ 3: What is the association between
dietary intake of total fat in individuals
birth through 18 years of age and
measures of growth and development?
KQ4: What is the association between
dietary intake of omega-6 and/or omega3 polyunsaturated fatty acids in
individuals birth through 18 years of age
and measures of growth and
development?
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PICOTS (POPULATION, INTERVENTION, COMPARATOR, OUTCOME, TIMING, SETTING/STUDY DESIGN)
Element
Inclusion criteria
Exclusion criteria
Population ............................
Exposure population:
• Individuals who are pregnant (KQ1) and/or lactating (KQ2) of any age or individuals from birth
through 18 years of age (KQ3 and 4) from the
general population (including those with overweight/obesity) not affected by a disease or
health-related condition that impacts fat absorption and/or metabolism; or taking medications
that alter the absorption or metabolism of dietary
fatty acid
Outcome population:
• Offspring of the pregnant individual (birth
through 18 years) not taking medications or affected by a disease or health-related condition
that impacts fat absorption and/or metabolism
Note: given the distinction between chronological age
versus pubertal stage, as well as heterogeneity in enrollment across age ranges, for studies meeting all
other eligibility criteria, we will consider exceptions to
the age criterion.a
Intervention (Exposure) ........
KQ1, 2, and 4:
• Dietary intake of total omega-3 PUFA, total
omega-6 PUFA, or total PUFA (omega-3 and
omega-6)
• Dietary intake of individual PUFA (examples: linoleic, alpha-linolenic, EPA, DHA)
• Dietary intake of a combination of long-chain
PUFA (example: EPA+DHA+DPA; DHA+ARA)
• Dietary intake of polyunsaturated fatty acids in
terms of a ratio (example, n-6:n-3 PUFA,
DHA:ARA)
KQ3:
• Total dietary fat intake (as either grams/day or %
of total energy intake from fat)
• A dietary pattern that describes and quantifies
intake of total dietary carbohydrate, total fat, and
total protein content (examples: low/high-fat diet;
low/high-carbohydrate diet; high-protein;
ketogenic diet)
Note: Dietary intake can be from foods, supplements,
and/or supplemented foods.b
• Non-human participants (e.g., animal studies, in-vitro
models).
• Studies that enroll participants taking medications or
with diseases/health-related conditions that impact
fatty acid absorption or metabolism (e.g., Crohn’s disease, ulcerative colitis, short-gut syndrome, cystic fibrosis, celiac). This includes cancer and malabsorption syndromes.
• Studies that exclusively enroll participants hospitalized with an illness or injury.
• Studies designed to induce weight loss or treat overweight and obesity through energy restriction or
hypocaloric diets for the purposes of treating additional or other medical conditions.
• Studies that exclusively enroll participants with severe undernourishment, underweight, stunting, or
wasting.
• Studies that enroll participants who are pre- or postbariatric surgery.
• Studies with enrollment exclusively of: pre-term babies (gestational age <37 weeks), babies admitted to
the NICU, babies that have low birth weight
(<2,500g) and/or babies that are small for gestational
age (for assessment of infant and child growth parameters and developmental outcomes).
• Studies that enroll infants with conditions treated/prevent by dietary supplementation (e.g., G- or GJtubes, fatty acid oxidation disorders, necrotizing
enterocolitis, attention deficit (and/or hyperactivity)
disorder, ADHD, autism, etc.).
KQ1, 2, and 4:
• Studies that do not quantify PUFA intake as either grams/day or % of total energy intake from
PUFA (e.g., studies where exposure is number
of fish servings per week).
• Studies that do not provide absolute intake of
fatty acids included in ratios.
• Studies that only assess fatty acid biomarker
wt% of total or concentrations.
• Studies that only assess fatty acid intake via infusions (parenteral [intralipid] or stable isotope).
• Studies that only assess exposure to fatty acids
from a single meal, or eating occasion such that
usual intake cannot be inferred.
• Studies that examine food products or dietary
supplements not widely available to U.S. consumers.
• Multi-component interventions that do not isolate
the effect or association of the PUFA exposure.
• Observational studies that do not account for
any confounders.
• Studies designed to induce weight loss or treat
participants who are determined to be overweight and obese through energy restriction or
hypocaloric diets for the purposes of treating additional or other medical conditions.
KQ3:
• Studies that do not describe the energy and entire macronutrient distribution of the diet (i.e.,
studies that do not report total carbohydrate,
total fat, and total protein contents of experimental or baseline diets).
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Federal Register / Vol. 89, No. 222 / Monday, November 18, 2024 / Notices
90697
PICOTS (POPULATION, INTERVENTION, COMPARATOR, OUTCOME, TIMING, SETTING/STUDY DESIGN)—Continued
Element
Inclusion criteria
Exclusion criteria
Comparator ..........................
KQ1, 2, and 4:
• Placebo
• Dietary intake of a different amount of fatty acids
relevant to the exposure:
Æ Total omega-3
Æ Total omega-6
Æ Individual PUFA
Æ Combination of long-chain PUFA
Æ Intake of PUFA in terms of a ratio
KQ3:
• Dietary intake of a different amount of total fat
KQ2, 3, and 4:
Infant and child (birth through 18 years) growth parameters
• Birth weight
• Weight and Weight-for-age percentile or Z-score
adjusted for gestational age
• Length or Height and Length-for-age or Heightfor-age percentile and Z-score adjusted for gestational age
• Head circumference and Head circumference
percentile and Z-score adjusted for gestational
age
Infant and child (birth through 18 years) developmental
outcomes c
• Cognitive/neurological
• Language/communication
• Movement/physical
• Visual function/acuity
• Social/emotional learning
KQ1:
• Risk of preterm birth
• All exposure or intervention durations will be included
• Outpatient; all settings except hospital and acute
care will be included
• Randomized controlled trials
• Prospective cohort studies
• Nested case-control studies
• Diet(s) with an energy intake that is statistically significantly higher or lower than the intervention/exposure diet (e.g., not isocaloric comparison).
• Studies that do not have a statistically significant difference between groups in PUFA or total fat intake.
• Studies comparing undefined exposures (e.g., comparisons of undefined quartiles).
Outcome ...............................
Timing ..................................
Setting ..................................
Study Design ........................
Geographic Location ............
Study Size ............................
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Language .............................
Publication Dates .................
• Locations with food products or dietary supplements
widely available to U.S. and/or Canadian consumers
• Countries rated very high on the Human Development Index (HDI) d at the time of data collection
• Studies including power calculations or effect sizes
• Studies with N ≥30 participants (for randomized clinical trials [RCTs]): ≥10 participants analyzed per
study arm)
• Articles published in English
• Articles published during or after 2000
• BMI, BMI z-score.
• Body composition and distribution (e.g., % fat mass,
fat-free mass, skin fold thicknesses).
• Incidence and prevalence of overweight, obesity.
• Inpatient; hospital and acute care.
•
•
•
•
•
•
•
•
•
•
•
Narrative reviews.
Systematic reviews.
Meta-analyses.
Scoping reviews.
Umbrella reviews.
Retrospective cohort studies.
Non-randomized controlled trials, including quasi-experimental and controlled before-and-after studies.
Cross-sectional studies.
Case-control studies.
All other study designs.
Locations not rated very high on the HDI.
• Studies with N <30 participants (for RCTs: <10 participants analyzed per study arm), without power calculations or effect sizes.
• Case studies and n = 1 samples.
• Non-randomized studies that do not account for any
potential confounders.
• Articles published in languages other than English.
• Articles published prior to 2000.
a For studies meeting all other eligibility criteria, studies enrolling populations aged 0 to older than 19 years will be included if: (a) results are
stratified by age group, allowing extraction of data for participants aged through 18 years; or (b) 85% of the population is aged through 18 years,
if results are not stratified by age group. The one exception is studies of adolescents; for those meeting all other eligibility criteria, studies enrolling adolescents through age 26, regardless of result stratification or percentage of population aged through 18 years, will be included. See the
Study Selection section.
b Dietary supplement is defined as a product intended to supplement the diet that contains one or more dietary ingredients (including vitamins,
minerals, herbs or other botanicals, amino acids, and other substances) intended to be taken by mouth as a pill, capsule, table, or liquid, and
that is labeled on the front panel as being a dietary supplement.
c See Section IV for an example table of measures with periodicity.
d United Nations Development Programme Human Development Reports, https://hdr.undp.org/data-center/human-development-index#/indicies/
HDI.
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90698
Federal Register / Vol. 89, No. 222 / Monday, November 18, 2024 / Notices
Dated: November 8, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024–26783 Filed 11–15–24; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–25–25AW; Docket No. CDC–2024–
0094]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other federal
agencies the opportunity to comment on
a proposed information collection, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on a proposed information
collection project titled National
Concussion Surveillance System. This
data collection is designed to allow CDC
to calculate the prevalence and
incidence of traumatic brain injuries
(TBI) for both adults and children, and
the circumstances related to TBIs
occurring in the preceding year.
DATES: CDC must receive written
comments on or before January 17,
2025.
SUMMARY:
You may submit comments,
identified by Docket No. CDC–2024–
0094 by either of the following methods:
• Federal eRulemaking Portal:
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Jeffrey M. Zirger, Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, MS H21–8, Atlanta,
Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
www.regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(www.regulations.gov) or by U.S. mail to
the address listed above.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
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ADDRESSES:
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proposed project or to obtain a copy of
the information collection plan and
instruments, contact Jeffrey M. Zirger,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road, NE,
H21–8, Atlanta, Georgia 30329;
Telephone: 404–639–7570; Email: omb@
cdc.gov.
SUPPLEMENTARY INFORMATION:
Under the Paperwork Reduction Act
of 1995 (PRA) (44 U.S.C. 3501–3520),
federal agencies must obtain approval
from the Office of Management and
Budget (OMB) for each collection of
information they conduct or sponsor. In
addition, the PRA also requires federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each new proposed
collection, each proposed extension of
existing collection of information, and
each reinstatement of previously
approved information collection before
submitting the collection to the OMB for
approval. To comply with this
requirement, we are publishing this
notice of a proposed data collection as
described below.
The OMB is particularly interested in
comments that will help:
1. Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected;
4. Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submissions
of responses; and
5. Assess information collection costs.
Proposed Project
National Concussion Surveillance
System—New—National Center for
Injury Prevention and Control (NCIPC),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
In 2014, an Institute of Medicine
(IOM) report titled ‘‘Sports-Related
Concussions in Youth: Improving the
Science, Changing the Culture,’’
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recommended that the U.S. Centers for
Disease Control and Prevention (CDC)
establish and oversee a national
surveillance system to accurately
determine the incidence of sportsrelated concussions [i.e., mild traumatic
brain injuries, or TBIs], including those
in youth ages five to 21. The report
further recommended that the cause,
nature, and extent of the concussive
injury also should be collected,
including the sport or activity, level of
competition, and signs and symptoms
consistent with a concussion. The IOM
recommendation was made because
there were significant gaps in
understanding of TBI, including
concussion, incidence and prevalence
estimates. Current non-fatal TBI
surveillance estimates typically utilize
emergency department (ED) or
hospitalization-focused data sources.
But these sources cannot account for
injuries that go untreated or injuries
diagnosed in primary care, urgent care,
or specialty care settings, potentially
missing information on millions of TBIs
sustained each year. Without an
accurate understanding of the burden,
trends, and characteristics of these
injuries, it is challenging to design or
focus effective prevention programs,
policies, or practices. The consequences
from TBI are staggering, with many
resulting in intensive and long-term care
needs. This data collection could help
fill significant knowledge gaps and
inform prevention efforts across the
country.
The purpose of this data collection is
to calculate the 12-month prevalence
and incidence of TBI for both adults and
children, and the circumstances related
to TBIs occurring in the preceding 12
months. The data collection instrument
is largely based on the instrument used
during the pilot that utilized cognitive
testing prior to deployment. Data
collected will include reports of head
injuries experienced in the preceding 12
months, and the most recent head injury
reported will be assessed for symptoms
of TBI. We will also query respondents
who sustained a head injury regarding
the mechanism of injury (cause) and
circumstances related to the TBI,
medical care received, impact on social
and school functioning, and information
related to returning to work/school/
play.
Data will be analyzed to produce
nationally representative 12-month
incidence and prevalence estimates of
non-fatal TBI in children (ages 5–17)
and adults. Data collected are likely to
be used by state and local governments,
researchers, voluntary health
organizations, physicians, health
educators, workplace wellness
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]]>Agencies
[Federal Register Volume 89, Number 222 (Monday, November 18, 2024)]
[Notices]
[Pages 90695-90698]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-26783]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Dietary Total Fat
Intake and Dietary Polyunsaturated Fatty Acid Intake and Child Growth
and Development Outcomes: A Systematic Review
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for supplemental evidence and data submission.
-----------------------------------------------------------------------
SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is
seeking scientific information submissions from the public. Scientific
information is being solicited to inform our review on Dietary Total
Fat Intake and Dietary Polyunsaturated Fatty Acid Intake and Child
Growth and Development Outcomes: A Systematic Review, which is
currently being conducted by the AHRQ's Evidence-based Practice Centers
(EPC) Program. Access to published and unpublished pertinent scientific
information will improve the quality of this review.
DATES: Submission Deadline on or before December 18, 2024.
ADDRESSES:
Email submissions: [email protected].
Print submissions:
Mailing Address: Center for Evidence and Practice Improvement,
Agency for Healthcare Research and Quality, ATTN: EPC SEADs
Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857.
Shipping Address (FedEx, UPS, etc.): Center for Evidence and
Practice Improvement, Agency for Healthcare Research and Quality, ATTN:
EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: Kelly Carper, Telephone: 301-427-1656
or Email: [email protected].
SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and
Quality has commissioned the Evidence-based Practice Centers (EPC)
Program to complete a review of the evidence for Dietary Total Fat
Intake and Dietary Polyunsaturated Fatty Acid Intake and Child Growth
and Development Outcomes: A Systematic Review. AHRQ is conducting this
review pursuant to Section 902 of the Public Health Service Act, 42
U.S.C. 299a.
The EPC Program is dedicated to identifying as many studies as
possible that are relevant to the questions for each of its reviews. In
order to do so, we are supplementing the usual manual and electronic
database searches of the literature by requesting information from the
public (e.g., details of studies conducted). We are looking for studies
that report on Dietary Total Fat Intake and Dietary Polyunsaturated
Fatty Acid Intake and Child Growth and Development Outcomes: A
Systematic Review. The entire research protocol is available online at:
https://effectivehealthcare.ahrq.gov/products/child-growth-development-outcomes/protocol.
This is to notify the public that the EPC Program would find the
following information on Dietary Total Fat Intake and Dietary
Polyunsaturated Fatty Acid Intake and Child Growth and Development
Outcomes: A Systematic Review helpful:
[ssquf] A list of completed studies that your organization has
sponsored for this topic. In the list, please indicate whether results
are available on ClinicalTrials.gov along with the ClinicalTrials.gov
trial number.
[ssquf] For completed studies that do not have results on
ClinicalTrials.gov, a summary, including the following elements, if
relevant: study number, study period, design, methodology, indication
and diagnosis, proper use instructions, inclusion and exclusion
criteria, primary and secondary outcomes, baseline characteristics,
number of patients screened/eligible/enrolled/lost to follow-up/
withdrawn/analyzed, effectiveness/efficacy, and safety results.
[ssquf] A list of ongoing studies that your organization has
sponsored for this topic. In the list, please provide the
ClinicalTrials.gov trial number or, if the trial is not registered, the
protocol for the study including, if relevant, a study number, the
study period, design, methodology, indication and diagnosis, proper use
instructions, inclusion and exclusion criteria, and primary and
secondary outcomes.
[ssquf] Description of whether the above studies constitute ALL
Phase II and above clinical trials sponsored by your organization for
this topic and an index outlining the relevant information in each
submitted file.
Your contribution is very beneficial to the Program. Materials
submitted must be publicly available or able to be made public.
Materials that are considered confidential; marketing materials; study
types not included in the review; or information on topics not included
in the review cannot be used by the EPC Program. This is a voluntary
request for information, and all costs for complying with this request
must be borne by the submitter.
The draft of this review will be posted on AHRQ's EPC Program
website and available for public comment for a period of 4 weeks. If
you would like to be notified when the draft is posted, please sign up
for the email list at: https://effectivehealthcare.ahrq.gov/email-updates.
The review will answer the following questions. This information is
provided as background. AHRQ is not requesting that the public provide
answers to these questions.
Key Questions (KQ)
KQ 1: What is the association between dietary intake of omega-6
and/or omega-3 polyunsaturated fatty acids during pregnancy and risk of
preterm birth?
KQ 1a: How are these associations affected by intervention/exposure
characteristics (for example, the ratio of different fatty acids)?
KQ 2: What is the association between dietary intake of omega-6
and/or omega-3 polyunsaturated fatty acids during pregnancy and/or
lactation and infant/child growth and developmental outcomes?
KQ 2a: How are these associations affected by intervention/exposure
characteristics (for example, the ratio of different fatty acids)?
[[Page 90696]]
KQ 3: What is the association between dietary intake of total fat
in individuals birth through 18 years of age and measures of growth and
development?
KQ4: What is the association between dietary intake of omega-6 and/
or omega-3 polyunsaturated fatty acids in individuals birth through 18
years of age and measures of growth and development?
PICOTS (Population, Intervention, Comparator, Outcome, Timing, Setting/Study Design)
----------------------------------------------------------------------------------------------------------------
Element Inclusion criteria Exclusion criteria
----------------------------------------------------------------------------------------------------------------
Population........................... Exposure population: Non-human
Individuals who are pregnant participants (e.g., animal
(KQ1) and/or lactating (KQ2) of any age studies, in-vitro models).
or individuals from birth through 18 Studies that enroll
years of age (KQ3 and 4) from the general participants taking
population (including those with medications or with diseases/
overweight/obesity) not affected by a health-related conditions
disease or health-related condition that that impact fatty acid
impacts fat absorption and/or metabolism; absorption or metabolism
or taking medications that alter the (e.g., Crohn's disease,
absorption or metabolism of dietary fatty ulcerative colitis, short-
acid gut syndrome, cystic
Outcome population: fibrosis, celiac). This
Offspring of the pregnant includes cancer and
individual (birth through 18 years) not malabsorption syndromes.
taking medications or affected by a Studies that
disease or health-related condition that exclusively enroll
impacts fat absorption and/or metabolism participants hospitalized
Note: given the distinction between with an illness or injury.
chronological age versus pubertal stage, Studies designed to
as well as heterogeneity in enrollment induce weight loss or treat
across age ranges, for studies meeting overweight and obesity
all other eligibility criteria, we will through energy restriction
consider exceptions to the age or hypocaloric diets for the
criterion.\a\ purposes of treating
additional or other medical
conditions.
Studies that
exclusively enroll
participants with severe
undernourishment,
underweight, stunting, or
wasting.
Studies that enroll
participants who are pre- or
post-bariatric surgery.
Studies with
enrollment exclusively of:
pre-term babies (gestational
age <37 weeks), babies
admitted to the NICU, babies
that have low birth weight
(<2,500g) and/or babies that
are small for gestational
age (for assessment of
infant and child growth
parameters and developmental
outcomes).
Studies that enroll
infants with conditions
treated/prevent by dietary
supplementation (e.g., G- or
GJ-tubes, fatty acid
oxidation disorders,
necrotizing enterocolitis,
attention deficit (and/or
hyperactivity) disorder,
ADHD, autism, etc.).
Intervention (Exposure).............. KQ1, 2, and 4: KQ1, 2, and 4:
Dietary intake of total omega-3 Studies that do not
PUFA, total omega-6 PUFA, or total PUFA quantify PUFA intake as
(omega-3 and omega-6) either grams/day or % of
Dietary intake of individual PUFA total energy intake from
(examples: linoleic, alpha-linolenic, PUFA (e.g., studies where
EPA, DHA) exposure is number of fish
Dietary intake of a combination servings per week).
of long-chain PUFA (example: EPA+DHA+DPA; Studies that do not
DHA+ARA) provide absolute intake of
Dietary intake of polyunsaturated fatty acids included in
fatty acids in terms of a ratio (example, ratios.
n-6:n-3 PUFA, DHA:ARA) Studies that only
KQ3: assess fatty acid biomarker
Total dietary fat intake (as wt% of total or
either grams/day or % of total energy concentrations.
intake from fat) Studies that only
A dietary pattern that describes assess fatty acid intake via
and quantifies intake of total dietary infusions (parenteral
carbohydrate, total fat, and total [intralipid] or stable
protein content (examples: low/high-fat isotope).
diet; low/high-carbohydrate diet; high- Studies that only
protein; ketogenic diet) assess exposure to fatty
Note: Dietary intake can be from foods, acids from a single meal, or
supplements, and/or supplemented eating occasion such that
foods.\b\ usual intake cannot be
inferred.
Studies that examine
food products or dietary
supplements not widely
available to U.S. consumers.
Multi-component
interventions that do not
isolate the effect or
association of the PUFA
exposure.
Observational
studies that do not account
for any confounders.
Studies designed to
induce weight loss or treat
participants who are
determined to be overweight
and obese through energy
restriction or hypocaloric
diets for the purposes of
treating additional or other
medical conditions.
KQ3:
Studies that do not
describe the energy and
entire macronutrient
distribution of the diet
(i.e., studies that do not
report total carbohydrate,
total fat, and total protein
contents of experimental or
baseline diets).
[[Page 90697]]
Comparator........................... KQ1, 2, and 4: Diet(s) with an
Placebo energy intake that is
Dietary intake of a different statistically significantly
amount of fatty acids relevant to the higher or lower than the
exposure: intervention/exposure diet
[cir] Total omega-3 (e.g., not isocaloric
[cir] Total omega-6 comparison).
[cir] Individual PUFA Studies that do not
[cir] Combination of long-chain PUFA have a statistically
[cir] Intake of PUFA in terms of a ratio significant difference
KQ3: between groups in PUFA or
Dietary intake of a different total fat intake.
amount of total fat Studies comparing
undefined exposures (e.g.,
comparisons of undefined
quartiles).
Outcome.............................. KQ2, 3, and 4: BMI, BMI z-score.
Infant and child (birth through 18 years) Body composition and
growth parameters distribution (e.g., % fat
Birth weight mass, fat-free mass, skin
Weight and Weight-for-age fold thicknesses).
percentile or Z-score adjusted for Incidence and
gestational age prevalence of overweight,
Length or Height and Length-for- obesity.
age or Height-for-age percentile and Z-
score adjusted for gestational age
Head circumference and Head
circumference percentile and Z-score
adjusted for gestational age
Infant and child (birth through 18 years)
developmental outcomes \c\
Cognitive/neurological
Language/communication
Movement/physical
Visual function/acuity
Social/emotional learning
KQ1:
Risk of preterm birth
Timing............................... All exposure or intervention
durations will be included
Setting.............................. Outpatient; all settings except Inpatient; hospital
hospital and acute care will be included and acute care.
Study Design......................... Randomized controlled trials Narrative reviews.
Prospective cohort studies Systematic reviews.
Nested case-control studies Meta-analyses.
Scoping reviews.
Umbrella reviews.
Retrospective cohort
studies.
Non-randomized
controlled trials, including
quasi-experimental and
controlled before-and-after
studies.
Cross-sectional
studies.
Case-control
studies.
All other study
designs.
Geographic Location.................. Locations with food products or Locations not rated
dietary supplements widely available to very high on the HDI.
U.S. and/or Canadian consumers
Countries rated very high on the
Human Development Index (HDI) \d\ at the
time of data collection
Study Size........................... Studies including power Studies with N <30
calculations or effect sizes participants (for RCTs: <10
Studies with N >=30 participants participants analyzed per
(for randomized clinical trials [RCTs]): study arm), without power
>=10 participants analyzed per study arm) calculations or effect
sizes.
Case studies and n =
1 samples.
Non-randomized
studies that do not account
for any potential
confounders.
Language............................. Articles published in English Articles published
in languages other than
English.
Publication Dates.................... Articles published during or Articles published
after 2000 prior to 2000.
----------------------------------------------------------------------------------------------------------------
\a\ For studies meeting all other eligibility criteria, studies enrolling populations aged 0 to older than 19
years will be included if: (a) results are stratified by age group, allowing extraction of data for
participants aged through 18 years; or (b) 85% of the population is aged through 18 years, if results are not
stratified by age group. The one exception is studies of adolescents; for those meeting all other eligibility
criteria, studies enrolling adolescents through age 26, regardless of result stratification or percentage of
population aged through 18 years, will be included. See the Study Selection section.
\b\ Dietary supplement is defined as a product intended to supplement the diet that contains one or more dietary
ingredients (including vitamins, minerals, herbs or other botanicals, amino acids, and other substances)
intended to be taken by mouth as a pill, capsule, table, or liquid, and that is labeled on the front panel as
being a dietary supplement.
\c\ See Section IV for an example table of measures with periodicity.
\d\ United Nations Development Programme Human Development Reports, https://hdr.undp.org/data-center/human-development-index#/indicies/HDI.
[[Page 90698]]
Dated: November 8, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024-26783 Filed 11-15-24; 8:45 am]
BILLING CODE 4160-90-P
