NCT04949451

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 2, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

3.9 years

First QC Date

June 16, 2021

Last Update Submit

August 19, 2025

Conditions

OverweightObesity

Outcome Measures

Primary Outcomes (1)

  • Body composition

    Body composition measured using dual x-ray absorptiometry to determine the ration of lean/fat-free mass to fat mass.

    Change is being assessed at baseline and final day (day 120) of the intervention.

Secondary Outcomes (12)

  • Whole body protein turnover

    Change is being assessed at baseline and final day (day 120) of the intervention.

  • Muscle mass

    Change is being assessed at baseline and final day (day 120) of the intervention.

  • Body weight

    Change is being assessed at baseline, 4, 8, and 12 weeks.

  • Sleep

    Change is being assessed at baseline and 12 weeks

  • Sleep Quality

    Change is being assessed at baseline, 4, 8, and 12 weeks

  • +7 more secondary outcomes

Study Arms (3)

TRF-C

PLACEBO COMPARATOR

Follows time restricted feeding protocol.

Other: Control group - time restricted feeding only

TRF-P

EXPERIMENTAL

Follows time restricted feeding protocol, consumes protein supplement

Dietary Supplement: Whey protein supplement

TRF-S

EXPERIMENTAL

Follows time restricted feeding protocol, consumes ketogenic supplement

Dietary Supplement: Ketogenic aid

Interventions

Whey protein supplementDIETARY_SUPPLEMENT

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

TRF-P
Ketogenic aidDIETARY_SUPPLEMENT

Participants consume ketogenic aid upon waking.

TRF-S
Control group - time restricted feeding onlyOTHER

Time restricted feeding.

TRF-C

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas

Fayetteville, Arkansas, 72704, United States

RECRUITING

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Jamie Baum, PhD

CONTACT

479-575-4474baum@uark.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 16, 2021

First Posted

July 2, 2021

Study Start

June 13, 2021

Primary Completion

April 30, 2025

Study Completion

December 30, 2025

Last Updated

August 26, 2025

Record last verified: 2025-08

Locations

US(1)