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Recruiting NCT04949451

Time Restricted Feeding, Muscle, and Metabolism

No phase Interventional Overweight Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Whey protein supplement, Ketogenic aid, Control group - time restricted feeding only.
Who it may be relevant to
Registry conditions: Overweight, Obesity. Basic parameters: 25 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Dietary supplement Whey protein supplement
    Participants consume whey protein at the beginning of the eating period.
  • Dietary supplement Ketogenic aid
    Participants consume ketogenic aid upon waking.
  • Other Control group - time restricted feeding only
    Time restricted feeding.

Primary outcome measures

  • Body composition [Time frame: Change is being assessed at baseline and final day (day 120) of the intervention.]
Secondary outcome measures (12)
  • Whole body protein turnover [Time frame: Change is being assessed at baseline and final day (day 120) of the intervention.]
  • Muscle mass [Time frame: Change is being assessed at baseline and final day (day 120) of the intervention.]
  • Body weight [Time frame: Change is being assessed at baseline, 4, 8, and 12 weeks.]
  • Sleep [Time frame: Change is being assessed at baseline and 12 weeks]
  • Sleep Quality [Time frame: Change is being assessed at baseline, 4, 8, and 12 weeks]
  • Mood [Time frame: Change is being assessed at baseline, 4, 8, and 12 weeks]
  • Grit [Time frame: Change is being assessed at baseline, 4, 8, and 12 weeks]
  • Self-reported physical activity [Time frame: Change is being assessed at baseline, 4, 8, and 12 weeks]
  • Dietary intake [Time frame: Change is being assessed at baseline, 4, 8, and 12 weeks]
  • Fasting glucose [Time frame: Change is being assessed at baseline, 4, 8, and 12 weeks]
  • Hand grip [Time frame: Change is being assessed at baseline, 4, 8, and 12 weeks]
  • Amino acids and metabolites [Time frame: Change is being assessed at baseline, 4, 8, and 12 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • University of Arkansas — Fayetteville

Identifiers

NCT: NCT04949451 · TRIMM062021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗