[Federal Register Volume 88, Number 114 (Wednesday, June 14, 2023)]
[Notices]
[Pages 38864-38866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-12677]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Evaluation of Dietary
Protein Intake Requirements
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for supplemental evidence and data submissions.
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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 Evaluation of
Dietary Protein Intake Requirements, 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published and unpublished pertinent scientific information will improve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 July 14, 2023.
ADDRESSES:
Email submissions: [email protected].
Print submissions:
Mailing Address: Center for Evidence and Practice Improvement,
Agency for Healthcare Research and Quality,
[[Page 38865]]
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 06E53A, 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 Evaluation of Dietary
Protein Intake Requirements. AHRQ is conducting this systematic 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 Evaluation of Dietary Protein Intake Requirements,
including those that describe adverse events. The entire research
protocol is available online at: https://effectivehealthcare.ahrq.gov/products/dietary-protein-intake/protocol.
This is to notify the public that the EPC Program would find the
following information on Evaluation of Dietary Protein Intake
Requirements helpful:
[ssquf] A list of completed studies that your organization has
sponsored for this indication. 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: 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 indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the trial is not registered, the
protocol for the study including 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 indication 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 indications 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://www.effectivehealthcare.ahrq.gov/email-updates.
The systematic 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 average daily dietary protein intake requirements
of apparently healthy individuals by life stage and sex?
KQ 2: What is the average daily dietary individual indispensable
amino acid intake requirements of apparently healthy individuals by
life stage and sex?
Population, Intervention, Comparator, Outcome, Timing, Setting/Study Design (PICOTS)
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Element Inclusion criteria Exclusion criteria
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Population KQ1 & 2............... Participants who are healthy Studies that exclusively
and/or have chronic diseases or enroll participants diagnosed with a
chronic disease risk factors, disease, hospitalized, or in a long-
including those with obesity term care facility with an illness
Studies that enroll some or injury (for this criterion,
participants diagnosed with a disease studies that exclusively enroll
or hospitalized or in a long-term participants with obesity will not
care facility with an illness or be excluded).
injury Studies that aim to treat
Studies that enroll some participants who have already been
participants diagnosed with a disease diagnosed with the outcome of
or with the health outcome of interest (except weight loss
interest interventions in overweight or obese
Participants who are pregnant subjects).
and lactating. Studies that exclusively
Age at intervention exposure: enroll undernourished participants.
[cir] Infants, children, adolescents Studies that exclusively
(0-18 years). enroll participants with a baseline
[cir] Adults (19-64). diet deficient in protein.
[cir] Older adults (65 years and Studies that exclusively
older). enroll preterm infants.
Studies that exclusively
enroll post-bariatric surgery
subjects.
Studies that exclusively
recruit elite athletes.
Participants with existing
conditions that clearly are known to
alter nutrient metabolism or
requirements, or those being treated
with medications that alter nutrient
metabolism.
Interventions KQ1 & 2............ Total daily protein intake Studies that only assess
level protein intake via infusions (rather
Total daily intake of than the GI tract).
indispensable AAs (Histidine, Studies that examine food
Isoleucine, Leucine, Lysine, products or dietary supplements not
Methionine, Phenylalanine, Threonine, widely available to U.S. consumers.
Tryptophan, Valine)
[[Page 38866]]
Multi-component
interventions that do not isolate
the effect or association of protein
(including protein and exercise
combinations).
Comparison KQ1 & 2............... Different total daily protein No comparator.
intake level
Different total daily intake
of indispensable AAs
Outcomes KQ1..................... Total protein requirement * as defined
by the following indicators or
criterion of adequacy, including but
not limited to:
Nitrogen balance method
Factorial method
Indicator AA oxidation method
Mean protein intake of
infants fed principally human milk (0-
6 months)
Mean protein content of human
milk (0-6 months)
Body composition (lean mass)
Linear growth for infants,
children, adolescents (0-18 years)
Activities of daily living
for older adults (65 years and older)
Outcomes KQ2..................... Indispensable AA requirement* as
defined by the following indicators
of adequacy, including but not
limited to:
Plasma AA response method
Direct AA oxidation method
24-hour AA balance method
Indicator AA oxidation method
Mean AA intake of infants fed
principally human milk (0-6 months)
Mean protein content of human
milk (0-6 months)
Timing KQ1 & 2................... All duration and follow up
Setting KQ1 & 2.................. All settings
Study Design KQ1 & 2............. Randomized controlled trials International and government
Non-randomized controlled reports.
trials, including quasi-experimental
and controlled before-and-after
studies
Narrative reviews.
Prospective cohort studies Systematic reviews, meta-
Nested case-control studies analyses, umbrella reviews, scoping
reviews.
Uncontrolled trials.
Case-control studies.
Uncontrolled before-and-
after studies.
Retrospective cohort
studies.
Study Size KQ1 & 2............... N < 6 participants and
without power for crossover studies.
Other studies with N < 50
participants (for RCTs--25
participants analyzed per study
arm), and without power
calculations.
Language KQ1 & 2................. English only (due to resource
limitations)
Geographic Location KQ1 & 2...... Locations with food products
or dietary supplements widely
available to U.S. consumers,
including those rated very high on
the Human Development Index
Publication Date KQ1 & 2......... 2000 to present
Publication Status KQ1 & 2....... Articles published in peer- Articles that have not been
reviewed journals peer reviewed and are not published
in peer-reviewed journals (e.g.,
unpublished data, manuscripts, pre-
prints, reports, abstracts,
conference proceedings).
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* Requirement is defined as the lowest daily intake value for a nutrient that will meet the need as defined by a
specified indicator or criterion of adequacy, of apparently healthy individuals.
Dated: June 8, 2023.
Marquita Cullom,
Associate Director.
[FR Doc. 2023-12677 Filed 6-13-23; 8:45 am]
BILLING CODE 4160-90-P