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

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT07700030
Status
Not Yet Recruiting

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Conditions

  • Weight Loss

Eligibility Criteria

Sex
ALL
Age
30 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • High protein diet — OTHER
    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)

Study Details

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.

Key Dates

First listed
Jul 13, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Nov 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: High Protein (HP) Resistance Training (RT)
    All participants will receive a HP dietary prescription targeting 2.5 g/kg fat-free mass (FFM)/day delivered by an RDN. Participants in the HP-RT arm will additionally complete supervised resistance training 2 days/week for 6 months under the guidance of a personal trainer/Certified Strength and Conditioning Specialist (CSCS).
  • Active Comparator: High Protein (HP)
    All participants will receive a HP dietary prescription targeting 2.5 g/kg FFM/day delivered by an Registered Dietitian Nutritionist (RDN).

Primary Outcome Measure

Changes in lean Skeletal Muscle Mass (SMM) quadriceps [ Time Frame: Baseline, Month 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016
Charlie Thao
[email protected]
646-939-1789
Collin Popp, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
NYU Langone Health· New York, NY

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