[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published and unpublished pertinent scientific information will improve 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