Impact of Time Restricted Feeding on Daily Protein Requirements

Not Applicable

Completed

• Conditions: Nutrition Disorders in Old Age
• Interventions: Other: isocaloric, isonitrogenous meals

• Registration Number: NCT05610644
• Lead Sponsor: University of Arkansas

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.

Study Timeline

• Study First Submitted: 2022-11-02
• Study First Submitted QC: 2022-11-02
• Study First Posted: 2022-11-09
• Study Start: 2023-03-29
• Primary Completion: 2024-10-03
• Study Completion: 2024-10-03
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TRF of RDA	isocaloric, isonitrogenous meals	A time-restricted model of consumption of the RDA of protein/day.
TRAD of 2RDA	isocaloric, isonitrogenous meals	A typical American dietary ingestion pattern of twice the RDA of protein/day.
TRAD of RDA	isocaloric, isonitrogenous meals	A typical American dietary ingestion pattern of the RDA of protein/day.
TRF of 2RDA	isocaloric, isonitrogenous meals	A time-restricted model of consumption of twice the RDA of protein/day.

Primary Outcome Measures

Name	Time	Method
Whole-body protein balance	24 hours	Volume of net protein produced per unit of time

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States