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Impact of Time Restricted Feeding on Daily Protein Requirements

Primary Purpose

Nutrition Disorders in Old Age

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
isocaloric, isonitrogenous meals
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Nutrition Disorders in Old Age

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Men and women ages 50-75 years. BMI 20-30 kg/m2 inclusive. Capable of providing informed consent. COVID-19 negative and/or asymptomatic Exclusion Criteria: Subject who does not/will not eat animal protein sources. Body mass index <20 or >30. Hemoglobin <10g/dL at screening. Platelets <150,000/uL at screening. History of diabetes. History of chemotherapy or radiation therapy for cancer in the 6 months prior to enrollment. History of gastrointestinal bypass/reduction surgery. History of a chronic inflammatory disease (e.g. what?) Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy. Currently using prescription blood thinning medications. Currently using corticosteroid medications. Unable or unwilling to suspend aspirin use for 7 days prior to Visit 3. Unwilling to avoid using protein or amino-acid supplements during participation. Subjects who are unwilling to fast overnight. Participating in >200 minutes/week of vigorous exercise and/or >4 days/week of resistance training.

Sites / Locations

  • University of Arkansas for Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Experimental

Experimental

Arm Label

TRF of RDA

TRAD of RDA

TRF of 2RDA

TRAD of 2RDA

Arm Description

A time-restricted model of consumption of the RDA of protein/day.

A typical American dietary ingestion pattern of the RDA of protein/day.

A time-restricted model of consumption of twice the RDA of protein/day.

A typical American dietary ingestion pattern of twice the RDA of protein/day.

Outcomes

Primary Outcome Measures

Whole-body protein balance
Volume of net protein produced per unit of time

Secondary Outcome Measures

Full Information

First Posted
November 2, 2022
Last Updated
April 6, 2023
Sponsor
University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT05610644
Brief Title
Impact of Time Restricted Feeding on Daily Protein Requirements
Official Title
Impact of Time Restricted Feeding on Daily Protein Requirements
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators aim to assess 24-hour protein kinetics at two different levels of protein intake: 0.8 (RDA) and 1.6g/kg/day (2RDA) during a normal dietary (TRAD) and a time restricted feeding (TRF) pattern in older adults.
Detailed Description
The investigators aim to assess 24-hour protein kinetics at two different levels of protein intake: 0.8 (RDA) and 1.6g/kg/day (2RDA) during a normal dietary (TRAD) and a time restricted feeding (TRF) pattern in older adults. Individuals in the TRF pattern will only consume food during a 6-hour eating period and fast for the remaining 18 hours. Individuals in the TRAD pattern will consume isocaloric and isonitrogenous (RDA or 2RDA) diet but consume an all-beef-breakfast. Participants will consume oral stable isotopes to measure muscle protein synthesis (MPS), whole-body muscle protein breakdown (MPB), and whole-body protein balance (WBPB). Appropriate muscle, blood samples, and urine will be collected throughout a 24-hour metabolic trial following a 2-day controlled diet.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutrition Disorders in Old Age

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TRF of RDA
Arm Type
Active Comparator
Arm Description
A time-restricted model of consumption of the RDA of protein/day.
Arm Title
TRAD of RDA
Arm Type
Active Comparator
Arm Description
A typical American dietary ingestion pattern of the RDA of protein/day.
Arm Title
TRF of 2RDA
Arm Type
Experimental
Arm Description
A time-restricted model of consumption of twice the RDA of protein/day.
Arm Title
TRAD of 2RDA
Arm Type
Experimental
Arm Description
A typical American dietary ingestion pattern of twice the RDA of protein/day.
Intervention Type
Other
Intervention Name(s)
isocaloric, isonitrogenous meals
Intervention Description
Participants will eat prepared study meals for 3 days that have either the RDA of protein per day or twice the RDA of protein per day.
Primary Outcome Measure Information:
Title
Whole-body protein balance
Description
Volume of net protein produced per unit of time
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Men and women ages 50-75 years. BMI 20-30 kg/m2 inclusive. Capable of providing informed consent. COVID-19 negative and/or asymptomatic Exclusion Criteria: Subject who does not/will not eat animal protein sources. Body mass index <20 or >30. Hemoglobin <10g/dL at screening. Platelets <150,000/uL at screening. History of diabetes. History of chemotherapy or radiation therapy for cancer in the 6 months prior to enrollment. History of gastrointestinal bypass/reduction surgery. History of a chronic inflammatory disease (e.g. what?) Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy. Currently using prescription blood thinning medications. Currently using corticosteroid medications. Unable or unwilling to suspend aspirin use for 7 days prior to Visit 3. Unwilling to avoid using protein or amino-acid supplements during participation. Subjects who are unwilling to fast overnight. Participating in >200 minutes/week of vigorous exercise and/or >4 days/week of resistance training.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Church
Phone
501-526-5769
Email
dchurch@uams.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Scott Schutzler
Phone
501-526-5734
Email
SESchutzler@uams.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Church
Organizational Affiliation
UAMS (University of Arkansas for Medical Sciences)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Church, Ph.D.
Phone
501-526-5769
Email
DChurch@uams.edu
First Name & Middle Initial & Last Name & Degree
Scott Schutzler, RN
Phone
5015265734
Email
seschutzler@uams.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Time Restricted Feeding on Daily Protein Requirements

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