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NCT Number: NCT04949451

Time Restricted Feeding, Muscle, and Metabolism

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas

Fayetteville, Arkansas, 72704, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whey Protein Supplement

Dietary Supplement

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

Ketogenic aid

Dietary Supplement

Participants consume ketogenic aid upon waking.

Control group - time restricted feeding only

Other

Time restricted feeding.

Primary outcomes

  1. 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

  1. Whole body protein turnover

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

    Whole body protein turnover will be measured using 15N-alanine

  2. Muscle mass

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

    Muscle mass will be measured using D3-creatine

  3. Body weight

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

    Body weight will be measured in kilograms.

  4. Sleep

    Time frame: Change is being assessed at baseline and 12 weeks

    Sleep will be assessed using wrist Actigraphy for sleep duration and total time in bed.

  5. Sleep Quality

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

    Sleep quality will be measured using the Pittsburgh Sleep Quality Index survey

  6. Mood

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

    Mood will be assessed using the Profile of Mood States Questionnaire

  7. Grit

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

    Grit will be assessed using the grit questionnaire.

  8. Self-reported physical activity

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

    Physical activity will be measured using the iPAQ survey

  9. Dietary intake

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

    Dietary intake will be measured using weighed, 3-day food records

  10. Fasting glucose

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

    Glucose will be measured as mg/dl

  11. Hand grip

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

    Hand grip will be measured using a dynamometer.

  12. Amino acids and metabolites

    Time frame: 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.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

University of Arkansas, Fayetteville

Other

Registry information

Official study title

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

Acronym: TRIMM

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jul 2, 2021
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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