Skip to main content
Clinical Trials/NCT05610644
NCT05610644CompletedNot Applicable

Impact of Time Restricted Feeding on Daily Protein Requirements

University of Arkansas1 site in 1 country61 target enrollmentStarted: March 29, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
61
Locations
1
Primary Endpoint
Whole-body protein balance

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
50 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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 >
  • •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
  • •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.

Arms & Interventions

TRAD of 2RDA

Experimental

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

Intervention: isocaloric, isonitrogenous meals (Other)

TRF of RDA

Active Comparator

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

Intervention: isocaloric, isonitrogenous meals (Other)

TRAD of RDA

Active Comparator

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

Intervention: isocaloric, isonitrogenous meals (Other)

TRF of 2RDA

Experimental

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

Intervention: isocaloric, isonitrogenous meals (Other)

Outcomes

Primary Outcomes

Whole-body protein balance

Time Frame: 24 hours

Volume of net protein produced per unit of time

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials