High-protein plUs reSistance Training in gLucagon-like pEptide 1 Receptor Agonist Users (HUSTLE) (NCT07700030) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
High-protein plUs reSistance Training in gLucagon-like pEptide 1 Receptor Agonist Users (HUSTLE)
United States32 participantsStarted 2026-07
Plain-language summary
The primary objective of this study is to examine the effects of a high-protein diet (HP) paired with resistance training (RT) compared with a HP diet alone, on skeletal muscle mass (SMM) volume of the (a) quadriceps and (b) rhomboids, and upper and lower body muscle strength in adults recently prescribed tirzepatide. The secondary objectives of this study are to compare changes in resting energy expenditure (REE), adaptive thermogenesis (AT), and body adiposity (SFV, VAT, and intramuscular FF) in the quadriceps and rhomboid muscles) between the high-protein diet with RT and the high-protein diet arms at 6 months.
Who can participate
Age range
30 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 30- 60 years
* BMI 27.0-37.0 kg/m² at screening
* English speaking (at this time, MyNetDiary, a food-logging app used for tracking protein-intake, is only set up for English, and our RDN is only capable of providing nutritional counseling in English)
* Received a prescription for tirzepatide, a second-generation oral or injectable dual GIP/GLP-1 receptor agonist (Zepbound/Mounjaro) that is FDA-approved for obesity; and
* Has not yet started tirzepatide and agrees to complete a 4-week run-in period at the initial dose with \<3% weight loss from baseline; OR
* Has initiated tirzepatide and is within the first 4 weeks at the initial dose with \<3% weight loss from pre-treatment baseline.
* On a stable regimen for major chronic conditions (e.g., antihypertensives, lipid-lowering agents, oral antidiabetics, hypothyroidism) for ≥ 8 weeks prior to enrollment.
* Willing and able to:
* (i) Receive high-protein diet counseling and attempt to achieve \~2.5 g/kg FFM /day protein;
* (ii) Attend scheduled nutrition telehealth visits with an RDN;
* (iii) Medically cleared for moderate-intensity resistance training 2 days/week (no condition that would preclude safe participation in either diet-only or diet plus resistance training).
* Willing and able to undergo whole-body MRI at baseline and 6 months without sedation.
* Able to understand procedures and provide written informed consent in English (at this time, MyNetDiary, a food-logging app used for t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in lean Skeletal Muscle Mass (SMM) quadriceps
Timeframe: Baseline, Month 6
2
Changes in lean Skeletal Muscle Mass (SMM) rhomboids