Impact of Time Restricted Feeding on Daily Protein Requirements

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.

Study Overview

• Status: Recruiting
• Conditions: Nutrition Disorders in Old Age
• Intervention / Treatment: Other: isocaloric, isonitrogenous meals

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Church; Phone Number: 501-526-5769; Email: dchurch@uams.edu
• Study Contact Backup: Name: Scott Schutzler; Phone Number: 501-526-5734; Email: SESchutzler@uams.edu

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Recruiting
      • University of Arkansas for Medical Sciences
      • Contact: David Church, Ph.D.; Phone Number: 501-526-5769; Email: DChurch@uams.edu
      • Contact: Scott Schutzler, RN; Phone Number: 5015265734; Email: seschutzler@uams.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Men and women ages 50-75 years.
2. BMI 20-30 kg/m2 inclusive.
3. Capable of providing informed consent.
4. COVID-19 negative and/or asymptomatic

Exclusion Criteria:

1. Subject who does not/will not eat animal protein sources.
2. Body mass index <20 or >30.
3. Hemoglobin <10g/dL at screening.
4. Platelets <150,000/uL at screening.
5. History of diabetes.
6. History of chemotherapy or radiation therapy for cancer in the 6 months prior to enrollment.
7. History of gastrointestinal bypass/reduction surgery.
8. History of a chronic inflammatory disease (e.g. what?)
9. Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy.
10. Currently using prescription blood thinning medications.
11. Currently using corticosteroid medications.
12. Unable or unwilling to suspend aspirin use for 7 days prior to Visit 3.
13. Unwilling to avoid using protein or amino-acid supplements during participation.
14. Subjects who are unwilling to fast overnight.
15. Participating in >200 minutes/week of vigorous exercise and/or >4 days/week of resistance training.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TRF of RDA; A time-restricted model of consumption of the RDA of protein/day.	Other: isocaloric, isonitrogenous meals; 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.
Active Comparator: TRAD of RDA; A typical American dietary ingestion pattern of the RDA of protein/day.	Other: isocaloric, isonitrogenous meals; 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.
Experimental: TRF of 2RDA; A time-restricted model of consumption of twice the RDA of protein/day.	Other: isocaloric, isonitrogenous meals; 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.
Experimental: TRAD of 2RDA; A typical American dietary ingestion pattern of twice the RDA of protein/day.	Other: isocaloric, isonitrogenous meals; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whole-body protein balance	Volume of net protein produced per unit of time	24 hours

Collaborators and Investigators

• Sponsor: University of Arkansas
• Investigators: Principal Investigator: David Church, UAMS (University of Arkansas for Medical Sciences)

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: November 2, 2022
• First Submitted That Met QC Criteria: November 2, 2022
• First Posted (Actual): November 9, 2022

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders
• Other Study ID Numbers: 275081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No