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OpenTrials
Completed

NCT Number: NCT05610644

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.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Whole-body protein balance

    Time frame: 24 hours

    Volume of net protein produced per unit of time

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 9, 2022
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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