OverweightTRIMMNCT04949451
Time Restricted Feeding, Muscle, and Metabolism
A study testing Whey protein supplement and Ketogenic aid in people with Overweight and Obesity, run by University of Arkansas, Fayetteville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Whey protein supplement and Ketogenic aid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2021to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Resides in Northwest Arkansas
- Age 25-50 years
- BMI > 25
- All ethnicities
- Female and male
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Arkansas
Fayetteville, Arkansas, 72704
Jamie I Baum, PhD, 479-575-4474, baum@uark.edu
About this study
Official title: 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.
- Conditions
- Overweight, Obesity
- Being tested
- Whey protein supplement, Ketogenic aid, Control group - time restricted feeding only
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey protein supplementDietary supplement
Participants consume whey protein at the beginning of the eating period.
Ketogenic aidDietary supplement
Participants consume ketogenic aid upon waking.
Control group - time restricted feeding onlyOther
Time restricted feeding.
| Study group | Role | What they receive |
|---|---|---|
| TRF-C | Placebo comparator | Follows time restricted feeding protocol. Receives: Other: Control group - time restricted feeding only |
| TRF-P | Experimental | Follows time restricted feeding protocol, consumes protein supplement Receives: Dietary Supplement: Whey protein supplement |
| TRF-S | Experimental | Follows time restricted feeding protocol, consumes ketogenic supplement Receives: Dietary Supplement: Ketogenic aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition
Body composition measured using dual x-ray absorptiometry to determine the ration of lean/fat-free mass to fat mass.
Measured: Change is being assessed at baseline and final day (day 120) of the intervention.
Secondary outcomes (12)
Whole body protein turnover
Whole body protein turnover will be measured using 15N-alanine
Measured: Change is being assessed at baseline and final day (day 120) of the intervention.
Muscle mass
Muscle mass will be measured using D3-creatine
Measured: Change is being assessed at baseline and final day (day 120) of the intervention.
Body weight
Body weight will be measured in kilograms.
Measured: 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.
Measured: Change is being assessed at baseline and 12 weeks
Sleep Quality
Sleep quality will be measured using the Pittsburgh Sleep Quality Index survey
Measured: Change is being assessed at baseline, 4, 8, and 12 weeks
Mood
Mood will be assessed using the Profile of Mood States Questionnaire
Measured: Change is being assessed at baseline, 4, 8, and 12 weeks
Grit
Grit will be assessed using the grit questionnaire.
Measured: Change is being assessed at baseline, 4, 8, and 12 weeks
Self-reported physical activity
Physical activity will be measured using the iPAQ survey
Measured: Change is being assessed at baseline, 4, 8, and 12 weeks
Dietary intake
Dietary intake will be measured using weighed, 3-day food records
Measured: Change is being assessed at baseline, 4, 8, and 12 weeks
Fasting glucose
Glucose will be measured as mg/dl
Measured: Change is being assessed at baseline, 4, 8, and 12 weeks
Hand grip
Hand grip will be measured using a dynamometer.
Measured: 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.
Measured: Change is being assessed at baseline, 4, 8, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start13 Jun 2021
- Primary completion30 Apr 2025
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arkansas, Fayetteville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamie Baum, University of Arkansas, Fayetteville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949451
- Sponsor's protocol ID
- TRIMM062021
- Acronym
- TRIMM
- Status last verified
- Aug 2025
- First submitted
- 16 Jun 2021
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Restricted Feeding Intervention for Muscle and Metabolic Health (TRIMM)
- ClinicalTrials.gov ID
- NCT04949451
- Acronym / sponsor ID
- TRIMM / TRIMM062021
- Conditions
- Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Arkansas, FayettevilleUniversity, hospital or other
- Study start
- 13 Jun 2021 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 2 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TRF-C | Placebo comparator | Other: Control group - time restricted feeding onlyFollows time restricted feeding protocol. |
| TRF-P | Experimental | Dietary Supplement: Whey protein supplementFollows time restricted feeding protocol, consumes protein supplement |
| TRF-S | Experimental | Dietary Supplement: Ketogenic aidFollows time restricted feeding protocol, consumes ketogenic supplement |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Resides in Northwest Arkansas
- Age 25-50 years
- BMI > 25
- All ethnicities
- Female and male
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey protein supplementParticipants consume whey protein at the beginning of the eating period. | Dietary supplement | TRF-P |
| Ketogenic aidParticipants consume ketogenic aid upon waking. | Dietary supplement | TRF-S |
| Control group - time restricted feeding onlyTime restricted feeding. | Other | TRF-C |
Primary outcome
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.
12 secondary outcomes
Whole body protein turnover
Time frame: 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.
Body weight
Time frame: Change is being assessed at baseline, 4, 8, and 12 weeks.
Sleep
Time frame: Change is being assessed at baseline and 12 weeks
Sleep Quality
Time frame: 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
Grit
Time frame: 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
Dietary intake
Time frame: 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
Hand grip
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey protein supplement and Ketogenic aid in people with Overweight and Obesity, run by University of Arkansas, Fayetteville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jamie Baum, PhD (479-575-4474, baum@uark.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition (time frame: Change is being assessed at baseline and final day (day 120) of the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.