High-protein plUs reSistance Training in gLucagon-like pEptide 1 Receptor Agonist Users (HUSTLE)

ConditionWeight Loss
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-60
SponsorNYU Langone Health

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Patients currently prescribed oral or injectable incretin mimetics containing GLP-1RAs, including Exenatide, Liraglutide, Lixisenatide, Dulaglutide, Semaglutide. Participants who are currently prescribed tirzepatide and have been using for >4 weeks will also be excluded.

Prior use of incretin mimetics containing GLP-1RAs with >3% weight loss in a 4-week period

Lost >5% body weight in the past 6 months

Has consistently resistance trained (>10 sessions) in the last year

Trial design

Treatments tested in this trial

  • High protein diet
  • Resistance Training (RT) Programs

Treatment groups

32 Participants
are divided into 2 treatment groups

Sponsors and collaborators