Time Restricted Feeding, Muscle, and Metabolism

Study Overview
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Brief Summary
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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.

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

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Dietary Supplement: Whey protein supplement
* Dietary Supplement: Ketogenic aid
* Other: Control group - time restricted feeding only


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |