Clinical trial NCT04949451: Time Restricted Feeding, Muscle, and Metabolism
Official title: Time Restricted Feeding Intervention for Muscle and Metabolic Health (TRIMM)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight
Obesity
Lead sponsor: University of Arkansas, Fayetteville
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 90
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Body composition
timeFrame: Change is being assessed at baseline and final day (day 120) of the intervention.
Secondary outcomes:
measure: Whole body protein turnover
timeFrame: Change is being assessed at baseline and final day (day 120) of the intervention.
measure: Muscle mass
timeFrame: Change is being assessed at baseline and final day (day 120) of the intervention.
measure: Body weight
timeFrame: Change is being assessed at baseline, 4, 8, and 12 weeks.
measure: Sleep
timeFrame: Change is being assessed at baseline and 12 weeks
measure: Sleep Quality
timeFrame: Change is being assessed at baseline, 4, 8, and 12 weeks
measure: Mood
timeFrame: Change is being assessed at baseline, 4, 8, and 12 weeks
measure: Grit
timeFrame: Change is being assessed at baseline, 4, 8, and 12 weeks
measure: Self-reported physical activity
timeFrame: Change is being assessed at baseline, 4, 8, and 12 weeks
measure: Dietary intake
timeFrame: Change is being assessed at baseline, 4, 8, and 12 weeks
measure: Fasting glucose
timeFrame: Change is being assessed at baseline, 4, 8, and 12 weeks
measure: Hand grip
timeFrame: Change is being assessed at baseline, 4, 8, and 12 weeks
measure: Amino acids and metabolites
timeFrame: Change is being assessed at baseline, 4, 8, and 12 weeks
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: University of Arkansas
state: Arkansas
Study officials:
References: