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

Обзор

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.

Вмешательства

• Другое High protein diet
  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.
• Поведенческое Resistance Training (RT) Programs
  Supervised RT program designed for muscle hypertrophy (2 sessions/week, \~45-60 minutes each)

Первичные конечные точки

• Changes in lean Skeletal Muscle Mass (SMM) quadriceps [Срок оценки: Baseline, Month 6]
• Changes in lean Skeletal Muscle Mass (SMM) rhomboids [Срок оценки: Baseline, Month 6]
• Changes in 3-Repetition Maximum (3RM) Bench Press [Срок оценки: Baseline, Month 6]
• Changes in 3-Repetition Maximum (3RM) Leg Press [Срок оценки: Baseline, Month 6]

Вторичные конечные точки (5)

• Changes in Resting Energy Expenditure (REE) [Срок оценки: Baseline, Month 6]
• Changes in Adaptive Thermogenesis (AT) [Срок оценки: Baseline, Month 6]
• Changes in subcutaneous fat volume (SFV) [Срок оценки: Baseline, Month 6]
• Changes in visceral adipose tissue (VAT) [Срок оценки: Baseline, Month 6]
• Changes in intramuscular fat fraction (FF) [Срок оценки: Baseline, Month 6]

Критерии участия

Критерии включения

• 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 tracking protein-intake, is only set up for English, and our RDN is only capable of providing nutritional counseling in English)

Критерии исключения

• 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
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• NYU Langone Health — New York

Идентификаторы

NCT: NCT07700030 · 26-00168

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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