[Federal Register Volume 88, Number 114 (Wednesday, June 14, 2023)]
[Notices]
[Pages 38867-38869]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-12678]



[[Page 38867]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on The Effect of Protein 
Intake on Health

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 The Effect of 
Protein Intake on Health, 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published and unpublished pertinent scientific information will improve 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, 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 The Effect of Protein 
Intake on Health. 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 The Effect of Protein Intake on Health, including those 
that describe adverse events. The entire research protocol is available 
online at: https://effectivehealthcare.ahrq.gov/products/effect-protein-intake/protocol.
    This is to notify the public that the EPC Program would find the 
following information on The Effect of Protein Intake on Health 
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 association between dietary protein intake and 
risk of bone disease?
    KQ 2: What is the association between dietary protein intake and 
risk of kidney disease?
    KQ 3: What is the association between dietary protein intake and 
risk of sarcopenia?

[[Page 38868]]



  Population, Intervention, Comparator, Outcome, Timing, Setting/Study
                             Design (PICOTS)
------------------------------------------------------------------------
           Element                  Inclusion             Exclusion
------------------------------------------------------------------------
Population KQ1..............  Participants who are  Participants sample
                               healthy and/or have   exclusively
                               chronic diseases or   diagnosed with a
                               chronic disease       disease or
                               risk factors,         hospitalized or in
                               including those       a long-term care
                               with obesity.         facility with an
                              Participants who are   illness or injury.
                               pregnant and         Participants who
                               lactating..           have already been
                              Age of participants    diagnosed with bone
                               (at intervention or   disease.
                               exposure):.          Participants with
                              [cir] Infants,         existing conditions
                               children, and         that clearly are
                               adolescents (0-18     known to alter
                               years)..              nutrient metabolism
                              [cir] Adults (19-64    or requirements, or
                               years)..              those being treated
                              [cir] Older adults     with medications
                               (65 years and         that alter nutrient
                               older)..              metabolism.
                                                    Participant sample
                                                     exclusively
                                                     undernourished.
                                                    Participant sample
                                                     exclusively with a
                                                     baseline diet
                                                     deficient in
                                                     protein.
                                                    Participant sample
                                                     exclusively pre-
                                                     term infant.
                                                    Participant sample
                                                     exclusively post-
                                                     bariatric surgery
                                                     subjects.
                                                    Participant sample
                                                     exclusively elite
                                                     athletes.
                                                    Non-human
                                                     participants (e.g.,
                                                     animal studies, in-
                                                     vitro models).
Population KQ2&3............  Participants who are  Participants sample
                               healthy and/or have   exclusively
                               chronic diseases or   diagnosed with a
                               chronic disease       disease or
                               risk factors,         hospitalized or in
                               including those       a long-term care
                               with obesity.         facility with an
                              Participants who are   illness or injury
                               pregnant and         Participants who
                               lactating..           have already been
                              Age of participants    diagnosed with
                               (at intervention or   kidney disease and/
                               exposure):.           or sarcopenia.
                              [cir] Adults (19-64   Participants with
                               years)..              existing conditions
                              [cir] Older adults     that clearly are
                               (65 years and         known to alter
                               older)..              nutrient metabolism
                                                     or requirements, or
                                                     those being treated
                                                     with medications
                                                     that alter nutrient
                                                     metabolism.
                                                    Participant sample
                                                     exclusively
                                                     undernourished.
                                                    Participant sample
                                                     exclusively with a
                                                     baseline diet
                                                     deficient in
                                                     protein.
                                                    Participant sample
                                                     exclusively post-
                                                     bariatric surgery
                                                     subjects.
                                                    Participant sample
                                                     exclusively elite
                                                     athletes.
                                                    Non-human
                                                     participants (e.g.,
                                                     animal studies, in-
                                                     vitro models).
Interventions KQ1-3.........  Total dietary         No specification on
                               protein intake from   the amount of
                               food, beverages,      protein intake
                               and dietary           (e.g., only the
                               supplements.          type of protein or
                                                     source of protein
                                                     reported).
                                                    Assessment of %AMDR,
                                                     but no description
                                                     of the entire
                                                     macronutrient
                                                     distribution of the
                                                     diet (i.e.,
                                                     examination a
                                                     single
                                                     macronutrient in
                                                     relation to
                                                     outcomes).
                                                    Protein intake via
                                                     infusions (rather
                                                     than the GI tract).
                                                    Food products or
                                                     dietary supplements
                                                     not widely
                                                     available to U.S.
                                                     consumers.
                                                    Protein intake
                                                     evaluated with
                                                     exercise.
Comparison KQ1-3............   Consumption  Comparison of
                               of different levels   different sources
                               of total dietary      of protein (i.e.,
                               protein intake.       animal versus plant
                               No            protein) without
                               comparator..          specification on
                                                     the levels of total
                                                     dietary protein
                                                     intake
Outcomes KQ1................  Bone outcomes:        ....................
                              [cir] Osteoporosis..
                              [cir] Osteopenia....
                              [cir] Fracture......
                              [cir] Bone mass
                               including bone
                               mineral density,
                               bone mineral
                               content..
Outcomes KQ2................  Kidney outcomes:      ....................
                              [cir] Incidence of
                               kidney stones or
                               ureteral stones..
                              [cir] Incidence of
                               CKD (including
                               evaluations from
                               estimated
                               glomerular
                               filtration (eGFR)
                               rate with or
                               without a parameter
                               for race)..
                              [cir] Kidney
                               insufficiency..
Outcomes KQ3................  Aging associated      ....................
                               sarcopenia and its
                               diagnostic
                               indicators,
                               including but not
                               limited to muscle
                               mass, muscle
                               function, muscle
                               strength.
Timing KQ1-3................  All duration and      ....................
                               follow up.
Setting KQ1-3...............  All settings.         ....................

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Study design KQ1-3..........   Randomized    Narrative
                               controlled trials     reviews.
                               (RCTs).               Systematic
                               Non-          reviews, meta-
                               randomized            analyses, umbrella
                               controlled trials,    reviews, scoping
                               including quasi-      reviews.
                               experimental and      Systematic
                               controlled before-    reviews or meta-
                               and-after studies.    analyses that
                               Prospective   exclusively include
                               cohort studies with   cross-sectional and/
                               or without            or uncontrolled
                               comparison group      studies.
                               with appropriate     
                               analytic technique.   Retrospective
                               Nested case-  cohort studies.
                               control studies..     All other
                                                     study designs.
Language KQ1-3..............  English only (due to  ....................
                               resource
                               limitations).
Geographic Location KQ1-3...  Locations with food   ....................
                               products or dietary
                               supplements widely
                               available to U.S.
                               consumers,
                               including those
                               rated very high on
                               the Human
                               Development Index.
Study size KQ1-3............  ....................  Studies with N < 50
                                                     participants (for
                                                     RCTs--25
                                                     participants
                                                     analyzed per study
                                                     arm), and without
                                                     power calculation.
Publication date KQ1-3......  2000 to present.      ....................
Publication status KQ1-3....  Articles published    Articles that have
                               in peer-reviewed      not been peer
                               journals.             reviewed and are
                                                     not published in
                                                     peer-reviewed
                                                     journals (e.g.,
                                                     unpublished data,
                                                     manuscripts, pre-
                                                     prints, reports,
                                                     abstracts,
                                                     conference
                                                     proceedings).
------------------------------------------------------------------------
Abbreviations: AMDR = Acceptable macronutrient distribution range; GI =
  gastrointestinal; U.S. = United States; KQ = key question; CKD =
  chronic kidney disease; eGFR = estimated glomerular filtration rate;
  RCT = randomized controlled trial.


    Dated: June 8, 2023.
Marquita Cullom,
Associate Director.
[FR Doc. 2023-12678 Filed 6-13-23; 8:45 am]
BILLING CODE 4160-90-P