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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • High protein diet

    Other intervention

    The standardized highprotein diet counseling focuses on achieving 2.5 g/kg FFM/day of dietary protein through food and commercially available protein powder supplements that will be provided to participants.

  • Resistance Training (RT) Programs

    Behavioral

    Supervised RT program designed for muscle hypertrophy (2 sessions/week, \~45-60 minutes each)

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: High Protein (HP) Resistance Training (RT)Experimental treatment 2 interventions
Group B: High Protein (HP)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Changes in lean Skeletal Muscle Mass (SMM) quadriceps

SMM will be assessed via MRI.

Time frame
Baseline, Month 6
2

Changes in lean Skeletal Muscle Mass (SMM) rhomboids

SMM will be assessed via MRI.

Time frame
Baseline, Month 6
3

Changes in 3-Repetition Maximum (3RM) Bench Press

Time frame
Baseline, Month 6
4

Changes in 3-Repetition Maximum (3RM) Leg Press

Time frame
Baseline, Month 6

Secondary outcomes

1

Changes in Resting Energy Expenditure (REE)

Time frame
Baseline, Month 6
2

Changes in Adaptive Thermogenesis (AT)

Time frame
Baseline, Month 6
3

Changes in subcutaneous fat volume (SFV)

Time frame
Baseline, Month 6
4

Changes in visceral adipose tissue (VAT)

Time frame
Baseline, Month 6

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: