Supplemental Evidence and Data Request on Dietary Saturated Fat Replacement and Plasma Lipid and Cardiovascular Events, 92932-92935 [2024-27488]
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Federal Register / Vol. 89, No. 227 / Monday, November 25, 2024 / Notices
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BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Dietary Saturated Fat
Replacement and Plasma Lipid and
Cardiovascular Events
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for supplemental
evidence and data submission.
AGENCY:
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 Saturated Fat Replacement and
Plasma Lipid and Cardiovascular
Events, which is currently being
conducted by the AHRQ’s Evidencebased 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Access to published and unpublished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 26, 2024.
ADDRESSES:
Email submissions: epc@
ahrq.hhs.gov.
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
SUMMARY:
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: epc@ahrq.hhs.gov.
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 Saturated Fat
Replacement and Plasma Lipid and
Cardiovascular Events. 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 Saturated Fat
Replacement and Plasma Lipid and
Cardiovascular Events. The entire
research protocol is available online at:
https://effectivehealthcare.ahrq.gov/
products/saturated-fat-replacement/
protocol.
This is to notify the public that the
EPC Program would find the following
information on Dietary Saturated Fat
Replacement and Plasma Lipid and
Cardiovascular Events helpful:
D 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.
D 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.
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 are the effects of replacing
dietary intake of total or individual
saturated fatty acids with unsaturated,
mono-unsaturated or polyunsaturated
fatty acids, carbohydrates, or protein on
plasma lipid concentrations in the
general population?
KQ 2: What are the effects of replacing
dietary intake of total or individual
saturated fatty acids with unsaturated,
mono-unsaturated or polyunsaturated
fatty acids, carbohydrates, or protein on
cardiovascular events in the general
population?
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PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING)
[Study eligibility criteria based on Population, Intervention, Comparator, Outcome (PICO), and other elements]
Element
Inclusion criteria
Population ..........................................................
Both Key Questions .........................................
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Both Key Questions
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92933
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING)—Continued
[Study eligibility criteria based on Population, Intervention, Comparator, Outcome (PICO), and other elements]
Element
Interventions ......................................................
Inclusion criteria
Exclusion criteria
General population, without CVD, with or without modifiable CV risk factors, including.
Æ Dyslipidemia (including if taking lipid
lowering medications).
Æ Overweight/obese .................................
Æ Hyperglycemia and related conditions,
including type 2 diabetes.
Æ Hypertension/high blood pressure ........
Key Question 1 .................................................
Children and adults ..........................................
Key Question 2 .................................................
Adults (≥18 years old) ......................................
• Participants with a health-related condition
or taking medications that impact fat absorption, fat metabolism.
• Participants taking weight loss medications,
including glucagon-like peptide-1 agonists.
• Undernourished, underweight, stunted, or
wasted participants.
• Participants who are pre- or post-bariatric
surgery.
• Participants with other chronic diseases
(e.g., cancer, gastrointestinal disease, rheumatic disease, chronic kidney disease,
neurologic diseases), including type 1 diabetes.
• Participants with clinical CVD (e.g., history
of myocardial infarction, angina, stroke, arrhythmia), including congenital heart diseases, or familial hypercholesterolemia.
Both Key Questions .........................................
• Diets with a lower intake of total saturated
fatty acids.
• Diets with a lower intake of individual saturated fatty acids.
• Diets with a lower intake of a combination
of saturated fatty acids other than stearic
acid (ranging from C8 to C16; i.e., caprylic,
caproic, lauric, myristic, palmitic).
• Saturated fatty acid intake is exchanged for:
Æ Carbohydrates, including different types
(complex including fiber, refined, sugars).
Æ Protein ...................................................
Æ Unsaturated fatty acids, any .................
Æ Mono-unsaturated fatty acids (MUFA) ..
Æ Polyunsaturated fatty acids (PUFA) ......
Æ Combination of the above .....................
• Dietary intake must be defined or described
prospectively (in real time).
• Must specify daily quantity of dietary saturated fat intake.
Both Key Questions
• Studies that do not quantify fatty acid intake
as either g/day or % of total energy intake
from saturated fat.
• Analyses with fat intake as a continuous
variable.
• Fatty acid intake during a single meal or
eating occasion.
• Fatty acid intake via infusion (not orally).
• Food products or dietary supplements not
widely available to U.S. consumers.
• Multi-component interventions (e.g., diet +
exercise vs. exercise or plant sterols + diet
vs. plant sterols) (adult studies).
• Multi-component interventions of statins +
diet where statins are being initiated. Dietary interventions among existing statin
users will be included.
• Interventions designed to induce weight loss
or treat overweight and obesity through energy restriction or hypocaloric diets.
• Interventions designed for the purposes of
treating medical conditions other than modifiable CV risk factors.
• Enteral feeding.
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Key Question 1 .................................................
For studies in children,
Æ Include multicomponent interventions
(e.g., diet + exercise vs. exercise).
Æ Infant formula.
Comparators ......................................................
Both Key Questions .........................................
• Diets with no exchange and, thus, a higher
intake of total saturated fatty acids, individual saturated fatty acids, or combination
of saturated fatty acids.
• Well defined conventional or usual diet .......
• Diets with same reduction in saturated fat
intake but different replacement (e.g., 6%
saturated fatty acids in all arms, replaced
with protein vs. replaced with carbohydrates).
Both Key Questions
Diets with a caloric intake that are significantly
higher or lower than the intervention/exposure diet.
Diets or interventions that vary substantially in
intake of macronutrients (or other factors)
other than the intervention and comparator
of interest.
Different dietary fat exposure (e.g., comparison of undefined quantiles).
Outcomes ..........................................................
Key Question 1 .................................................
Key Question 1
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92934
Federal Register / Vol. 89, No. 227 / Monday, November 25, 2024 / Notices
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING)—Continued
[Study eligibility criteria based on Population, Intervention, Comparator, Outcome (PICO), and other elements]
Element
Inclusion criteria
Exclusion criteria
• Plasma lipoprotein concentrations ................
Æ LDL cholesterol (LDL-c) ........................
Æ HDL cholesterol (HDL-c) .......................
Æ Non-HDL-cholesterol .............................
Æ Triglycerides (triacylglycerol) (Tg) .........
Æ Lipoprotein(a) ........................................
Æ Apolipoprotein B (ApoB) .......................
• Total cholesterol (TC).
• TC:HDL ratio.
• LDL:HDL ratio.
• Chylomicrons.
• VLDL-c.
• IDL-c.
• Other apolipoproteins.
• Lipoprotein profiles.
• Evaluations of fatty acid biomarker levels.
Key Question 2
• Other cardiac or vascular related outcomes.
• Participant reported events.
Key Question 2 .................................................
• Cardiovascular events
Æ Atherosclerotic cardiovascular disease
(total).
Æ Major adverse cardiac (or cerebral)
events (MAC[C]E).
Æ Specific cardiovascular events
D Myocardial infarction
D Coronary heart/artery disease
D Peripheral vascular/artery disease
Æ Revascularization (for studies published after 1995).
Æ Cardiovascular disease-related mortality.
Æ Stroke ....................................................
Æ Incident atrial fibrillation ........................
Subgroups/effect modifiers of interest ...............
Both Key Questions .........................................
Æ Specific life stages
Æ Infants (for Key Question 1 only)
Æ Children and adolescents (for Key
Question 1 only).
Æ Adults (19–64)
Æ Older adults (≥65)
Æ Pregnant or postpartum
Æ Menopausal status.
None.
• Other characteristics
Æ Sex (male, female)
Æ Socioeconomic status
Æ Social determinants of health
Æ Race/ethnicity
Æ Physical activity level
Æ Anthropometry
Æ Health status, including type 2 diabetes
Æ Percent of total energy intake replaced
Æ Dietary trans fatty acid intake
Æ Baseline lipid concentrations
Æ Dietary cholesterol intake.
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Design ................................................................
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Key Question 1 .................................................
• Studies of adults ...........................................
Æ Parallel or cross-over randomized controlled trials (RCTs).
D n ≥25/group * ..................................
• Studies of children ........................................
Æ Parallel or cross-over RCTs ..................
D n ≥25/group * ..................................
Æ Nonrandomized comparative studies
D Must account for potential confounders.
D Dietary intake must be defined or
described prospectively.
D n ≥50/group *
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Both Key Questions
• Observational studies that do not account
for confounders.
• Analyses of dietary fat as a continuous variable (e.g., RR per g/day intake) without an
analysis at a threshold (e.g., RR for > vs <
threshold).
• All other study designs.
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Federal Register / Vol. 89, No. 227 / Monday, November 25, 2024 / Notices
92935
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING)—Continued
[Study eligibility criteria based on Population, Intervention, Comparator, Outcome (PICO), and other elements]
Element
Inclusion criteria
Exclusion criteria
Key Question 2 .................................................
• Studies of adults
Æ Parallel or cross-over RCTs
D n ≥25/group *
Æ Nonrandomized comparative studies
D Must account for potential confounders.
D Dietary intake must be defined or
described prospectively.
D We will aim for a minimum of about
10 observational studies for each
specific intervention—CV event
pair (e.g., reduced saturated fat
and stroke). We will thus select the
largest observational studies within
each category.†.
D n ≥100/group.
Timing ................................................................
Key Question 1 .................................................
• Minimum intervention length: 4 weeks .........
• In cross-over studies, any change in outcome measure must exclude data from the
first week after end of any prior treatments
Key Question 2 .................................................
• Minimum follow-up
Æ If population has no CV risk factors: 10
years.
Æ If population has one or more CV risk
factors (or unselected general population): 5 years.
None.
Setting ................................................................
• General community settings, including nursing homes, assisted living facilities, etc.
• Hospital or other acute care settings.
• Institutionalized, confined settings (e.g.,
prisons)
Publication .........................................................
• English language
• Published in peer-reviewed journals.
* Minimum sample size may be altered depending on the number of eligible studies found.
† Applying this approach for the 2016 AHRQ report n-3 fatty acids and cardiovascular disease (https://doi.org/10.23970/AHRQEPCERTA223),
we included: for cardiac event outcomes, observational studies with at least 10,000 participants; for stroke outcomes, at least 3000 participants;
for arrhythmia outcomes, at least 2000 participants; congestive heart failure outcomes, at least 700 participants; and for peripheral vascular disease events and MACE outcomes, at least 500 participants. In all instances, if a study meets eligibility criteria for any outcome, we will extract all
outcomes of interest from that study; therefore, there will be multiple instances of studies being included for an outcome even though the study
might not have met study size criteria for that specific outcome.
CV = cardiovascular; CVD = cardiovascular disease; MUFA = mono-unsaturated fatty acids; PUFA = polyunsaturated fatty acids; c = cholesterol; LDL = low-density lipoprotein; IDL = intermediate-density lipoprotein; HDL high-density lipoprotein; TC—total cholesterol; Tg = Triglycerides/
Triacylglycerols; apoA = apolipoprotein; MAC[C]E = Major adverse cardiac (or cerebro) events; BMI = body mass index; KQ = key question; N =
number of participants.
Dated: November 19, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024–27488 Filed 11–22–24; 8:45 am]
BILLING CODE 4160–90–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Toxic Substances and
Disease Registry
[30Day–25–0047]
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Agency for
Toxic Substances and Disease Registry
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for Public Comment and
Recommendations’’ notice on August
16, 2024, to obtain comments from the
public and affected agencies. ATSDR
did not receive comments related to the
previous notice. This notice serves to
allow an additional 30 days for public
and affected agency comments.
ATSDR will accept all comments for
this proposed information collection
project. The Office of Management and
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]]>Agencies
[Federal Register Volume 89, Number 227 (Monday, November 25, 2024)]
[Notices]
[Pages 92932-92935]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27488]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Dietary Saturated Fat
Replacement and Plasma Lipid and Cardiovascular Events
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
Saturated Fat Replacement and Plasma Lipid and Cardiovascular Events,
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 26, 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 Saturated Fat
Replacement and Plasma Lipid and Cardiovascular Events. 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 Saturated Fat Replacement and Plasma Lipid and
Cardiovascular Events. The entire research protocol is available online
at: https://effectivehealthcare.ahrq.gov/products/saturated-fat-replacement/protocol.
This is to notify the public that the EPC Program would find the
following information on Dietary Saturated Fat Replacement and Plasma
Lipid and Cardiovascular Events 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 are the effects of replacing dietary intake of total or
individual saturated fatty acids with unsaturated, mono-unsaturated or
polyunsaturated fatty acids, carbohydrates, or protein on plasma lipid
concentrations in the general population?
KQ 2: What are the effects of replacing dietary intake of total or
individual saturated fatty acids with unsaturated, mono-unsaturated or
polyunsaturated fatty acids, carbohydrates, or protein on
cardiovascular events in the general population?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and
Setting)
[Study eligibility criteria based on Population, Intervention,
Comparator, Outcome (PICO), and other elements]
------------------------------------------------------------------------
Element Inclusion criteria Exclusion criteria
------------------------------------------------------------------------
Population...................... Both Key Questions Both Key Questions
[[Page 92933]]
General
population, Participants with
without CVD, with a health-related
or without condition or
modifiable CV taking
risk factors, medications that
including. impact fat
[cir] Dyslipidemia absorption, fat
(including if metabolism.
taking lipid
lowering Participants
medications). taking weight
[cir] Overweight/ loss medications,
obese. including
[cir] glucagon-like
Hyperglycemia and peptide-1
related agonists.
conditions,
including type 2 Undernourished,
diabetes. underweight,
[cir] Hypertension/ stunted, or
high blood wasted
pressure. participants.
Key Question 1....
Children and Participants who
adults. are pre- or post-
Key Question 2.... bariatric
Adults (>=18 years surgery.
old).
Participants with
other chronic
diseases (e.g.,
cancer,
gastrointestinal
disease,
rheumatic
disease, chronic
kidney disease,
neurologic
diseases),
including type 1
diabetes.
Participants with
clinical CVD
(e.g., history of
myocardial
infarction,
angina, stroke,
arrhythmia),
including
congenital heart
diseases, or
familial
hypercholesterole
mia.
------------------------------------------------------------------------
Interventions................... Both Key Questions Both Key Questions
Diets Studies
with a lower that do not
intake of total quantify fatty
saturated fatty acid intake as
acids. either g/day or %
Diets of total energy
with a lower intake from
intake of saturated fat.
individual Analyses
saturated fatty with fat intake
acids. as a continuous
Diets variable.
with a lower Fatty
intake of a acid intake
combination of during a single
saturated fatty meal or eating
acids other than occasion.
stearic acid Fatty
(ranging from C8 acid intake via
to C16; i.e., infusion (not
caprylic, orally).
caproic, lauric, Food
myristic, products or
palmitic). dietary
Saturated supplements not
fatty acid intake widely available
is exchanged for:. to U.S.
[cir] consumers.
Carbohydrates, Multi-
including component
different types interventions
(complex (e.g., diet +
including fiber, exercise vs.
refined, sugars). exercise or plant
[cir] Protein..... sterols + diet
[cir] Unsaturated vs. plant
fatty acids, any. sterols) (adult
[cir] Mono- studies).
unsaturated fatty Multi-
acids (MUFA). component
[cir] interventions of
Polyunsaturated statins + diet
fatty acids where statins are
(PUFA). being initiated.
[cir] Combination Dietary
of the above. interventions
Dietary among existing
intake must be statin users will
defined or be included.
described
prospectively (in Interventions
real time). designed to
Must induce weight
specify daily loss or treat
quantity of overweight and
dietary saturated obesity through
fat intake. energy
restriction or
hypocaloric
diets.
Interventions
designed for the
purposes of
treating medical
conditions other
than modifiable
CV risk factors.
Enteral
feeding.
Key Question 1....
For studies in
children,.
[cir] Include
multicomponent
interventions
(e.g., diet +
exercise vs.
exercise).
[cir] Infant
formula.
------------------------------------------------------------------------
Comparators..................... Both Key Questions Both Key Questions
Diets Diets with a
with no exchange caloric intake
and, thus, a that are
higher intake of significantly
total saturated higher or lower
fatty acids, than the
individual intervention/
saturated fatty exposure diet.
acids, or Diets or
combination of interventions
saturated fatty that vary
acids. substantially in
Well intake of
defined macronutrients
conventional or (or other
usual diet. factors) other
Diets than the
with same intervention and
reduction in comparator of
saturated fat interest.
intake but Different dietary
different fat exposure
replacement (e.g., comparison
(e.g., 6% of undefined
saturated fatty quantiles).
acids in all
arms, replaced
with protein vs.
replaced with
carbohydrates).
------------------------------------------------------------------------
Outcomes........................ Key Question 1.... Key Question 1
[[Page 92934]]
Plasma Total
lipoprotein cholesterol (TC).
concentrations. TC:HDL
[cir] LDL ratio.
cholesterol (LDL- LDL:HDL
c). ratio.
[cir] HDL
cholesterol (HDL- Chylomicrons.
c). VLDL-c.
[cir] Non-HDL- IDL-c.
cholesterol. Other
[cir] apolipoproteins.
Triglycerides
(triacylglycerol) Lipoprotein
(Tg). profiles.
[cir]
Lipoprotein(a). Evaluations of
[cir] fatty acid
Apolipoprotein B biomarker levels.
(ApoB).
Key Question 2.... Key Question 2
Other
Cardiovascular cardiac or
events. vascular related
[cir] outcomes.
Atherosclerotic
cardiovascular Participant
disease (total). reported events.
[cir] Major
adverse cardiac
(or cerebral)
events (MAC[C]E).
[cir] Specific
cardiovascular
events.
[ssquf] Myocardial
infarction.
[ssquf] Coronary
heart/artery
disease.
[ssquf] Peripheral
vascular/artery
disease.
[cir]
Revascularization
(for studies
published after
1995).
[cir]
Cardiovascular
disease-related
mortality.
[cir] Stroke......
[cir] Incident
atrial
fibrillation.
------------------------------------------------------------------------
Subgroups/effect modifiers of Both Key Questions None.
interest.
[cir] Specific
life stages
[cir] Infants (for
Key Question 1
only).
[cir] Children and
adolescents (for
Key Question 1
only).
[cir] Adults (19-
64).
[cir] Older adults
(>=65).
[cir] Pregnant or
postpartum.
[cir] Menopausal
status.
------------------------------------------------------------------------
Other
characteristics
[cir] Sex (male,
female).
[cir]
Socioeconomic
status.
[cir] Social
determinants of
health.
[cir] Race/
ethnicity.
[cir] Physical
activity level.
[cir]
Anthropometry.
[cir] Health
status, including
type 2 diabetes.
[cir] Percent of
total energy
intake replaced.
[cir] Dietary
trans fatty acid
intake.
[cir] Baseline
lipid
concentrations.
[cir] Dietary
cholesterol
intake.
------------------------------------------------------------------------
Design.......................... Key Question 1.... Both Key Questions
Studies
of adults. Observational
[cir] Parallel or studies that do
cross-over not account for
randomized confounders.
controlled trials Analyses
(RCTs). of dietary fat as
[ssquf] n >=25/ a continuous
group *. variable (e.g.,
Studies RR per g/day
of children. intake) without
[cir] Parallel or an analysis at a
cross-over RCTs. threshold (e.g.,
[ssquf] n >=25/ RR for > vs <
group *. threshold).
[cir] All other
Nonrandomized study designs.
comparative
studies.
[ssquf] Must
account for
potential
confounders.
[ssquf] Dietary
intake must be
defined or
described
prospectively.
[ssquf] n >=50/
group *.
[[Page 92935]]
Key Question 2....
Studies
of adults.
[cir] Parallel or
cross-over RCTs.
[ssquf] n >=25/
group *.
[cir]
Nonrandomized
comparative
studies.
[ssquf] Must
account for
potential
confounders.
[ssquf] Dietary
intake must be
defined or
described
prospectively.
[ssquf] We will
aim for a minimum
of about 10
observational
studies for each
specific
intervention--CV
event pair (e.g.,
reduced saturated
fat and stroke).
We will thus
select the
largest
observational
studies within
each
category.[dagger].
[ssquf] n >=100/
group.
------------------------------------------------------------------------
Timing.......................... Key Question 1.... None.
Minimum
intervention
length: 4 weeks.
In cross-
over studies, any
change in outcome
measure must
exclude data from
the first week
after end of any
prior treatments.
Key Question 2....
Minimum
follow-up.
[cir] If
population has no
CV risk factors:
10 years.
[cir] If
population has
one or more CV
risk factors (or
unselected
general
population): 5
years.
------------------------------------------------------------------------
Setting......................... General Hospital
community or other acute
settings, care settings.
including nursing
homes, assisted Institutionalized
living , confined
facilities, etc. settings (e.g.,
prisons)
------------------------------------------------------------------------
Publication..................... English
language
Published
in peer-reviewed
journals.
------------------------------------------------------------------------
* Minimum sample size may be altered depending on the number of eligible
studies found.
[dagger] Applying this approach for the 2016 AHRQ report n-3 fatty acids
and cardiovascular disease (https://doi.org/10.23970/AHRQEPCERTA223),
we included: for cardiac event outcomes, observational studies with at
least 10,000 participants; for stroke outcomes, at least 3000
participants; for arrhythmia outcomes, at least 2000 participants;
congestive heart failure outcomes, at least 700 participants; and for
peripheral vascular disease events and MACE outcomes, at least 500
participants. In all instances, if a study meets eligibility criteria
for any outcome, we will extract all outcomes of interest from that
study; therefore, there will be multiple instances of studies being
included for an outcome even though the study might not have met study
size criteria for that specific outcome.
CV = cardiovascular; CVD = cardiovascular disease; MUFA = mono-
unsaturated fatty acids; PUFA = polyunsaturated fatty acids; c =
cholesterol; LDL = low-density lipoprotein; IDL = intermediate-density
lipoprotein; HDL high-density lipoprotein; TC--total cholesterol; Tg =
Triglycerides/Triacylglycerols; apoA = apolipoprotein; MAC[C]E = Major
adverse cardiac (or cerebro) events; BMI = body mass index; KQ = key
question; N = number of participants.
Dated: November 19, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024-27488 Filed 11-22-24; 8:45 am]
BILLING CODE 4160-90-P
