Time Restricted Feeding, Muscle, and Metabolism (TRIMM)

Time Restricted Feeding Intervention for Muscle and Metabolic Health (TRIMM)

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Overweight
• Intervention / Treatment: Other: Control group - time restricted feeding only; Dietary supplement: Whey protein supplement; Dietary supplement: Ketogenic aid

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jamie Baum, PhD; Phone Number: 479-575-4474; Email: baum@uark.edu

Study Locations

• United States
  • Arkansas
    • Fayetteville, Arkansas, United States, 72704
      • Recruiting
      • University of Arkansas
      • Contact: Jamie I Baum, PhD; Phone Number: 479-575-4474; Email: baum@uark.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: TRF-C; Follows time restricted feeding protocol.	Other: Control group - time restricted feeding only; Time restricted feeding.
Experimental: TRF-P; Follows time restricted feeding protocol, consumes protein supplement	Dietary supplement: Whey protein supplement; Participants consume whey protein at the beginning of the eating period.
Experimental: TRF-S; Follows time restricted feeding protocol, consumes ketogenic supplement	Dietary supplement: Ketogenic aid; Participants consume ketogenic aid upon waking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whole body protein turnover	Whole body protein turnover will be measured using 15N-alanine	Change is being assessed at baseline and final day (day 120) of the intervention.
Muscle mass	Muscle mass will be measured using D3-creatine	Change is being assessed at baseline and final day (day 120) of the intervention.
Body weight	Body weight will be measured in kilograms.	Change is being assessed at baseline, 4, 8, and 12 weeks.
Sleep	Sleep will be assessed using wrist Actigraphy for sleep duration and total time in bed.	Change is being assessed at baseline and 12 weeks
Sleep Quality	Sleep quality will be measured using the Pittsburgh Sleep Quality Index survey	Change is being assessed at baseline, 4, 8, and 12 weeks
Mood	Mood will be assessed using the Profile of Mood States Questionnaire	Change is being assessed at baseline, 4, 8, and 12 weeks
Grit	Grit will be assessed using the grit questionnaire.	Change is being assessed at baseline, 4, 8, and 12 weeks
Self-reported physical activity	Physical activity will be measured using the iPAQ survey	Change is being assessed at baseline, 4, 8, and 12 weeks
Dietary intake	Dietary intake will be measured using weighed, 3-day food records	Change is being assessed at baseline, 4, 8, and 12 weeks
Fasting glucose	Glucose will be measured as mg/dl	Change is being assessed at baseline, 4, 8, and 12 weeks
Hand grip	Hand grip will be measured using a dynamometer.	Change is being assessed at baseline, 4, 8, and 12 weeks
Amino acids and metabolites	Blood will be collected and plasma amino acids and metabolites will be assessed using commercially available kit for amino acid analysis for all circulating amino acids.	Change is being assessed at baseline, 4, 8, and 12 weeks

Collaborators and Investigators

• Sponsor: University of Arkansas, Fayetteville

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2021
• Primary Completion (Actual): April 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: June 16, 2021
• First Submitted That Met QC Criteria: June 25, 2021
• First Posted (Actual): July 2, 2021

Study Record Updates

• Last Update Posted (Estimated): August 26, 2025
• Last Update Submitted That Met QC Criteria: August 19, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: TRIMM062021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No