Time Restricted Feeding, Muscle, and Metabolism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-13

Study Completion Date

2025-12-30

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.

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Detailed Description

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Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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TRF-C

Follows time restricted feeding protocol.

Group Type PLACEBO_COMPARATOR

Control group - time restricted feeding only

Intervention Type OTHER

Time restricted feeding.

TRF-P

Follows time restricted feeding protocol, consumes protein supplement

Group Type EXPERIMENTAL

Whey protein supplement

Intervention Type DIETARY_SUPPLEMENT

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

TRF-S

Follows time restricted feeding protocol, consumes ketogenic supplement

Group Type EXPERIMENTAL

Ketogenic aid

Intervention Type DIETARY_SUPPLEMENT

Participants consume ketogenic aid upon waking.

Interventions

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Whey protein supplement

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

Intervention Type DIETARY_SUPPLEMENT

Ketogenic aid

Participants consume ketogenic aid upon waking.

Intervention Type DIETARY_SUPPLEMENT

Control group - time restricted feeding only

Time restricted feeding.

Intervention Type OTHER

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

Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes