Time Restricted Feeding, Muscle, and Metabolism (TRIMM)

August 19, 2025 updated by: Jamie Baum, University of Arkansas, Fayetteville

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Jamie Baum, PhD
  • Phone Number: 479-575-4474
  • Email: baum@uark.edu

Study Locations

  • United States
    • Arkansas
      • Fayetteville, Arkansas, United States, 72704
        • Recruiting
        • University of Arkansas
        • Contact:
          • Jamie I Baum, PhD
          • Phone Number: 479-575-4474
          • Email: baum@uark.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: TRF-C
Follows time restricted feeding protocol.
Other: Control group - time restricted feeding only
Time restricted feeding.
Experimental: TRF-P
Follows time restricted feeding protocol, consumes protein supplement
Dietary supplement: Whey protein supplement
Participants consume whey protein at the beginning of the eating period.
Experimental: TRF-S
Follows time restricted feeding protocol, consumes ketogenic supplement
Dietary supplement: Ketogenic aid
Participants consume ketogenic aid upon waking.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Change is being assessed at baseline and final day (day 120) of the intervention.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Change is being assessed at baseline and final day (day 120) of the intervention.
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
Change is being assessed at baseline and final day (day 120) of the intervention.
Body weight
Time Frame: Change is being assessed at baseline, 4, 8, and 12 weeks.
Body weight will be measured in kilograms.
Change is being assessed at baseline, 4, 8, and 12 weeks.
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.
Change is being assessed at baseline and 12 weeks
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
Change is being assessed at baseline, 4, 8, and 12 weeks
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
Change is being assessed at baseline, 4, 8, and 12 weeks
Grit
Time Frame: Change is being assessed at baseline, 4, 8, and 12 weeks
Grit will be assessed using the grit questionnaire.
Change is being assessed at baseline, 4, 8, and 12 weeks
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
Change is being assessed at baseline, 4, 8, and 12 weeks
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
Change is being assessed at baseline, 4, 8, and 12 weeks
Fasting glucose
Time Frame: Change is being assessed at baseline, 4, 8, and 12 weeks
Glucose will be measured as mg/dl
Change is being assessed at baseline, 4, 8, and 12 weeks
Hand grip
Time Frame: Change is being assessed at baseline, 4, 8, and 12 weeks
Hand grip will be measured using a dynamometer.
Change is being assessed at baseline, 4, 8, and 12 weeks
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.
Change is being assessed at baseline, 4, 8, and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Arkansas, Fayetteville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 13, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 2, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TRIMM062021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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