Weight LossNCT07700030
High-protein plUs reSistance Training in gLucagon-like pEptide 1 Receptor Agonist Users (HUSTLE)
A study testing High protein diet and Resistance Training (RT) Programs in people with Weight Loss, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Weight Loss
- What is being tested?
- High protein diet and Resistance Training (RT) Programs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2026to Dec 2027
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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 tracking protein-intake, is only set up for English, and our RDN is only capable of providing nutritional counseling in English)
Who cannot join
- 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
- Currently taking medication or supplements that have been shown to impact muscle function and muscle mass in the last 6 months
- Participants who live outside of the tri-state area and/or are not willing to come to New York City for in-person visits outlined
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- Plans to be out of town more than 2 consecutive weeks or >6 weeks total over the next 6 months
- Type 1 or 2 diabetes; uncontrolled diabetes (e.g., HbA1c > 6.4% if specified); recurrent severe hypoglycemia or hypoglycemia unawareness.
- Moderate-to-severe chronic kidney disease (e.g., eGFR < 45-60 mL/min/1.73 m2 final cutoff per protocol) or other renal disease
- Decompensated cirrhosis, severe chronic liver disease, or active liver disease
- Unstable cardiovascular disease (e.g., myocardial infarction (MI), stroke, coronary revascularization, or hospitalization for unstable angina or decompensated heart failure (HF) within <6 months)
- Active malignancy requiring systemic therapy in the past 6-months (excluding non-melanoma skin cancer)
- Serious medical/psychiatric conditions making participation unsafe or likely to impair adherence
- Pregnant, planning pregnancy within 6 months, or breastfeeding; women of childbearing potential unwilling to use effective contraception per institutional/drug-label guidance.
- Conditions requiring protein restriction (e.g., advanced Chronic Kidney Disease (CKD), relevant inborn errors of metabolism).
- Severe, poorly controlled gout/hyperuricemia
- Significant GI disease impairing tolerance or absorption (e.g., active Inflammatory Bowel Disease (IBD) with frequent flares, short bowel syndrome, severe gastroparesis beyond expected GLP-1 effects)
- Severe food allergies or intolerances that preclude a high-protein diet or ingestion of whey or pea protein and associated additives/ingredients of the protein powders used in this study.
- Has or previously had an eating disorder
- Severe musculoskeletal, neuromuscular, or other conditions that preclude moderate-intensity RT
- Advised not to exercise by their general practitioner or medical professional or refusal to obtain medical clearance if indicated by Physical Activity Readiness Questionnaire (PAR-Q) answers
- Standard contraindications to MRI: tattoos with metallic ink, pacemaker, cerebral and/or cochlear implant, metal in the eye, severe claustrophobia, presence of electronic devices or ferromagnetic metallic foreign or implanted objects that could constitute a hazard, inability to lie flat, or any other contraindication for MRI.
- Weight >200kg, or large body habitus which the MRI scanner cannot accommodate.
- Inability or unwillingness to attend a reasonable proportion of RT sessions and refusal of accommodations
- Concurrent enrollment in another weight management intervention
- Prior bariatric surgery within the past 12 months or planned bariatric surgery within the 6-month study period.
- Active alcohol or drug use disorder
- Significant cognitive impairment or language barrier precluding informed consent or adherence
- Any reason that could compromise the participants' safety, based on the judgment of the investigators and/or clinical coordinators.
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
NYU Langone Health
New York, New York, 10016
Charlie Thao, 646-939-1789, Charlie.thao@nyulangone.org
Collin Popp, PhD
About this study
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.
- Conditions
- Weight Loss
- Being tested
- High protein diet, Resistance Training (RT) Programs
- Keywords
- GLP-1, tirzepatide
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High protein dietOther
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) ProgramsBehavioural
Supervised RT program designed for muscle hypertrophy (2 sessions/week, ~45-60 minutes each)
| Study group | Role | What they receive |
|---|---|---|
| High Protein (HP) Resistance Training (RT) | Experimental | 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). Receives: Other: High protein diet; Behavioral: Resistance Training (RT) Programs |
| High Protein (HP) | Active comparator | All participants will receive a HP dietary prescription targeting 2.5 g/kg FFM/day delivered by an Registered Dietitian Nutritionist (RDN). Receives: Other: High protein diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in lean Skeletal Muscle Mass (SMM) quadriceps
SMM will be assessed via MRI.
Measured: Baseline, Month 6
Changes in lean Skeletal Muscle Mass (SMM) rhomboids
SMM will be assessed via MRI.
Measured: Baseline, Month 6
Changes in 3-Repetition Maximum (3RM) Bench Press
Measured: Baseline, Month 6
Changes in 3-Repetition Maximum (3RM) Leg Press
Measured: Baseline, Month 6
Secondary outcomes (5)
Changes in Resting Energy Expenditure (REE)
Measured: Baseline, Month 6
Changes in Adaptive Thermogenesis (AT)
Measured: Baseline, Month 6
Changes in subcutaneous fat volume (SFV)
Measured: Baseline, Month 6
Changes in visceral adipose tissue (VAT)
Measured: Baseline, Month 6
Changes in intramuscular fat fraction (FF)
Measured: Baseline, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Collin Popp, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07700030
- Sponsor's protocol ID
- 26-00168
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be distrusted to other researchers for this study. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Dr. Collin Popp, collin.popp@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-protein plUs reSistance Training in gLucagon-like pEptide 1 Receptor Agonist Users (HUSTLE)
- ClinicalTrials.gov ID
- NCT07700030
- Acronym / sponsor ID
- 26-00168
- Conditions
- Weight Loss
- Keywords
- GLP-1, tirzepatide
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Jul 2026 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Protein (HP) Resistance Training (RT) | Experimental | Other: High protein diet, Behavioral: Resistance Training (RT) ProgramsAll 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). |
| High Protein (HP) | Active comparator | Other: High protein dietAll participants will receive a HP dietary prescription targeting 2.5 g/kg FFM/day delivered by an Registered Dietitian Nutritionist (RDN). |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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
- On a stable regimen for major chronic conditions (e.g., antihypertensives, lipid-lowering agents, oral antidiabetics, hypothyroidism) for ≥ 8 weeks prior to enrollment.
Key exclusion criteria (29 listed)
- 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
- Currently taking medication or supplements that have been shown to impact muscle function and muscle mass in the last 6 months
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 |
|---|---|---|
| High protein dietThe 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. | Other | High Protein (HP), High Protein (HP) Resistance Training (RT) |
| Resistance Training (RT) ProgramsSupervised RT program designed for muscle hypertrophy (2 sessions/week, ~45-60 minutes each) | Behavioural | High Protein (HP) Resistance Training (RT) |
Primary outcome
Changes in lean Skeletal Muscle Mass (SMM) quadriceps
Time frame: Baseline, Month 6
SMM will be assessed via MRI.
Changes in lean Skeletal Muscle Mass (SMM) rhomboids
Time frame: Baseline, Month 6
SMM will be assessed via MRI.
Changes in 3-Repetition Maximum (3RM) Bench Press
Time frame: Baseline, Month 6
Changes in 3-Repetition Maximum (3RM) Leg Press
Time frame: Baseline, Month 6
5 secondary outcomes
Changes in Resting Energy Expenditure (REE)
Time frame: Baseline, Month 6
Changes in Adaptive Thermogenesis (AT)
Time frame: Baseline, Month 6
Changes in subcutaneous fat volume (SFV)
Time frame: Baseline, Month 6
Changes in visceral adipose tissue (VAT)
Time frame: Baseline, Month 6
Changes in intramuscular fat fraction (FF)
Time frame: Baseline, Month 6
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 13 Jul 2026.
- Individual participant dataSharing planned: No. IPD will not be distrusted to other researchers for this study. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Dr. Collin Popp, collin.popp@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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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.
Collin Popp, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High protein diet and Resistance Training (RT) Programs in people with Weight Loss, run by NYU Langone Health 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 13 inclusion and 29 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: opening soon, as of the sponsor's last update on 13 Jul 2026. 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. 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 Charlie Thao (646-939-1789, Charlie.thao@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in lean Skeletal Muscle Mass (SMM) quadriceps (time frame: Baseline, Month 6). The study lists 4 primary outcomes in all. 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 13 Jul 2026.