Recruiting

Time Restricted Feeding

Sponsor:

University of Arkansas, Fayetteville

Code:

NCT04949451

Conditions

Overweight

Obesity

Eligibility Criteria

Sex: All

Age: 25 - 50

Healthy Volunteers: Accepted

Interventions

Whey protein supplement

Ketogenic aid

Control group - time restricted feeding only

Study Details

Brief summary:

Effective nutrition strategies for combatting and/or preventing obesity still need to be identified. This has been the case despite the numerous and different approaches that have been taken. Potential targets for combatting/preventing obesity have been identified, but long-term solutions have not emerged. This study uses time restricted feeding to study the role of dietary protein in obesity prevention and/or treatment. The objectives are to determine the role of skeletal muscle mass as a driver of energy-sensing mechanisms and peripheral signals that regulate appetite and energy intake in overweight and obese adults and to determine the effects of protein timing on muscle mass to regulate appetite and energy intake in overweight and obese adults.

Conditions

Overweight

Obesity

Study ID

NCT04949451

Start date

Jun 13, 2021

Status verified date

Aug, 2025

Completion date

Dec 30, 2025

Anticipated

Primary completion date

Apr 30, 2025

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Resides in Northwest Arkansas
  • Age 25-50 years
  • BMI > 25
  • All ethnicities
  • Female and male

Exclusion Criteria:

  • Food allergies
  • Pregnant or breastfeeding
  • Dietary restrictions (e.g. vegetarian, vegan, etc.)
  • Trying to lose weight in last 3 months
  • Pre-existing health conditions related to obesity (e.g. cardiovascular disease, diabetes, hypertension)
  • Prescription medications related to heart disease or type 2 diabetes
  • Fear of needles
  • Smoker or vaping
  • Currently taking protein supplements or other nutritional supplements which may interfere with study outcomes
  • Consumes >4 alcoholic beverages per week

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: TRF-C

Follows time restricted feeding protocol.

experimental: TRF-P

Follows time restricted feeding protocol, consumes protein supplement

experimental: TRF-S

Follows time restricted feeding protocol, consumes ketogenic supplement

Interventions

Whey protein supplement

Participants consume whey protein at the beginning of the eating period.

Ketogenic aid

Participants consume ketogenic aid upon waking.

Control group - time restricted feeding only

Time restricted feeding.

Primary outcome measure

  • Body composition [ Time Frame: Change is being assessed at baseline and final day (day 120) of the intervention. ]

Central Contacts and Locations

Central contacts

Locations

University of Arkansas

Recruiting

Fayetteville, Arkansas, United States, 72704

Contacts

More Information

Sponsor

University of Arkansas, Fayetteville

Last update posted

Aug 26, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arkansas, Fayetteville on 2025-08-26.