Impact of Time Restricted Feeding on Daily Protein Requirements

NCT05610644 | Completed

• 1 other identifier: 275081
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutrition Disorders in Old Age

Outcome Measures

Primary Outcomes (1)

• Whole-body protein balance

  Volume of net protein produced per unit of time

  24 hours

Study Arms (4)

TRF of RDA

ACTIVE COMPARATOR

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

Other: isocaloric, isonitrogenous meals

TRAD of RDA

ACTIVE COMPARATOR

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

Other: isocaloric, isonitrogenous meals

TRF of 2RDA

EXPERIMENTAL

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

Other: isocaloric, isonitrogenous meals

TRAD of 2RDA

EXPERIMENTAL

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

Other: isocaloric, isonitrogenous meals

Interventions

isocaloric, isonitrogenous meals OTHER

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.

TRAD of 2RDA; TRAD of RDA; TRF of 2RDA; TRF of RDA

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Study Officials

• David Church

  UAMS (University of Arkansas for Medical Sciences)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 9, 2022
• Study Start: March 29, 2023
• Primary Completion: October 3, 2024
• Study Completion: October 3, 2024
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)