Time Restricted Feeding, Muscle, and Metabolism

Not Applicable

Recruiting

• Conditions: Overweight; Obesity
• Interventions: Other: Control group - time restricted feeding only; Dietary Supplement: Whey protein supplement; Dietary Supplement: Ketogenic aid

• Registration Number: NCT04949451
• Lead Sponsor: University of Arkansas, Fayetteville

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-13
• Study First Submitted: 2021-06-16
• Study First Submitted QC: 2021-06-25
• Study First Posted: 2021-07-02
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-13
• Primary Completion: 2025-04-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TRF-C	Control group - time restricted feeding only	Follows time restricted feeding protocol.
TRF-P	Whey protein supplement	Follows time restricted feeding protocol, consumes protein supplement
TRF-S	Ketogenic aid	Follows time restricted feeding protocol, consumes ketogenic supplement

Primary Outcome Measures

Name	Time	Method
Body composition	Change is being assessed at baseline and final day (day 120) of the intervention.	Body composition measured using dual x-ray absorptiometry to determine the ration of lean/fat-free mass to fat mass.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Arkansas; 🇺🇸 Fayetteville, Arkansas, United States