Time Restricted Feeding, Muscle, and Metabolism (TRIMM)

University of Arkansas, Fayetteville

Status: Enrolling

Conditions: Overweight; Obesity

Treatments: Dietary Supplement: Whey protein supplement; Other: Control group - time restricted feeding only; Dietary Supplement: Ketogenic aid

Study type: Interventional

Funder types: Other

Identifiers

NCT04949451

TRIMM062021

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 25 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups, including a placebo group

TRF-C

Placebo Comparator group

Description:

Follows time restricted feeding protocol.

Treatment:

Other: Control group - time restricted feeding only

TRF-P

Experimental group

Description:

Follows time restricted feeding protocol, consumes protein supplement

Treatment:

Dietary Supplement: Whey protein supplement

TRF-S

Experimental group

Description:

Follows time restricted feeding protocol, consumes ketogenic supplement

Treatment:

Dietary Supplement: Ketogenic aid