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Clinical Trials/NCT04949451
NCT04949451
Recruiting
Not Applicable

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

University of Arkansas, Fayetteville1 site in 1 country90 target enrollmentJune 13, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Overweight
Sponsor
University of Arkansas, Fayetteville
Enrollment
90
Locations
1
Primary Endpoint
Body composition
Status
Recruiting
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 13, 2021
End Date
December 30, 2025
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jamie Baum

Associate Professor

University of Arkansas, Fayetteville

Eligibility Criteria

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

Outcomes

Primary Outcomes

Body composition

Time Frame: 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 Outcomes

  • Grit(Change is being assessed at baseline, 4, 8, and 12 weeks)
  • Amino acids and metabolites(Change is being assessed at baseline, 4, 8, and 12 weeks)
  • 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)
  • Self-reported physical activity(Change is being assessed at baseline, 4, 8, and 12 weeks)
  • Mood(Change is being assessed at baseline, 4, 8, and 12 weeks)
  • Hand grip(Change is being assessed at baseline, 4, 8, and 12 weeks)
  • Dietary intake(Change is being assessed at baseline, 4, 8, and 12 weeks)
  • Fasting glucose(Change is being assessed at baseline, 4, 8, and 12 weeks)

Study Sites (1)

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