Clinical trial

Combatting Muscle Loss in Obese Adult Patients on GLP-1 Medications Through Dietary Counseling and Exercise During Treatment Evaluates Whether a 12-week Exercise and Individualized Nutrition Program Can Reduce Muscle and Bone Loss and Improve Strength, Fitness, and Function in Obese Adults on GLP-1

Opening soon · Phase 4 · 1 countries · Registry ID NCT07554417

Opening soonPhase 4Interventional

What this study is about

Obesity remains a critical public health challenge and is associated with increased rates of morbidity, mortality, and chronic disease worldwide. In recent years, glucagon-like peptide-1 (GLP-1) receptor agonists, such as semaglutide, have emerged as highly effective pharmacological treatments for obesity, producing substantial weight loss and favorable metabolic improvements. These medications are now widely prescribed, with estimates suggesting that nearly 12% of Americans are currently using or have previously used GLP-1 therapies. Despite their demonstrated benefits, growing evidence indicates that GLP-1-associated weight loss may be accompanied by unintended reductions in skeletal muscle and bone mass. This potential side effect is of increasing concern, as muscle and bone are essential for metabolic health, physical function, injury prevention, and recovery from illness or surgical intervention. Loss of skeletal muscle during weight reduction may negatively impact strength, mobility, insulin sensitivity, and long-term health outcomes. These risks may be further compounded in individuals experiencing reduced physical activity, mechanical unloading, or prolonged caloric deficits. In clinical and surgical populations, such as individuals undergoing orthopedic procedures, mechanical unloading and disuse already predispose patients to muscle and bone atrophy. When combined with pharmacologically induced weight loss, these factors may further hinder recovery, impair functional capacity, and compromise musculoskeletal integrity. As GLP-1 therapies are increasingly adopted across diverse populations, understanding how to preserve lean mass and bone health during treatment has become an important clinical and public health priority. Exercise training, particularly resistance training, combined with appropriate nutritional support, has consistently been shown to preserve and enhance skeletal muscle and bone mass during weight loss. Structured exercise interventions can mitigate sarcopenia and osteopenia while improving muscular strength, cardiorespiratory fitness, metabolic health, and overall physical function. Similarly, individualized dietary counseling, particularly when focused on adequate protein intake and nutrient timing, plays a critical role in supporting muscle protein synthesis and skeletal health during caloric restriction. Together, these lifestyle strategies may not only counteract the potential adverse musculoskeletal effects associated with GLP-1 therapy but also enhance treatment efficacy by improving cardiovascular risk profiles, insulin sensitivity, systemic inflammation, and physical resilience. Despite the growing use of GLP-1 medications, there remains a limited body of prospective research examining structured lifestyle interventions specifically designed to preserve muscle and bone mass during GLP-1-induced weight loss. Addressing this gap is essential to ensure that pharmacological obesity treatments support long-term health, functional independence, and quality of life. Integrating exercise and nutrition interventions into GLP-1 treatment protocols may represent a scalable and clinically meaningful strategy to optimize outcomes and reduce unintended consequences of rapid weight loss. The purpose of this study is to evaluate whether a structured lifestyle intervention combining exercise and individualized nutritional counseling can mitigate skeletal muscle mass loss in obese adults undergoing treatment with GLP-1…

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age40 Years to 55 Years
SexAll
Healthy volunteersNot accepted
ConditionGLP - 1, Obesity & Overweight, Muscle Loss, Exercise Intervention, Dietary Assessment

Full registry criteria

Inclusion Criteria: * Age between 40 and 55 years * Body Mass Index (BMI) greater than 30 * Body fat percentage greater than 30% for males and 40% for females * Android to gynoid fat ratio greater than 1.0 * Currently eligible for GLP-1 therapy * No diagnosis of Type II diabetes Exclusion Criteria: * Presence of abnormal ECG findings, including arrhythmias or ischemic changes * Hypertensive response to exercise, defined as systolic blood pressure exceeding 250 mmHg or diastolic pressure exceeding 115 mmHg * Hypotensive response to exercise, defined as a drop in systolic pressure greater than 10 mmHg with increasing workload * VO₂ max below 15 ml/kg/min * Borg Rating of Perceived Exertion (RPE) greater than 19 during submaximal workloads * Any contraindications to exercise as defined by ACSM guidelines * Musculoskeletal limitations that prevent safe participation in exercise

Treatments and study arms

Semaglutide

Drug

FDA-approved GLP-1 receptor agonist administered once weekly per standard of care

Dietary Counseling

Behavioral

Weekly individualized nutrition counseling focused on nutrition education, meal planning, and macronutrient intake to support lean mass preservation during GLP-1 therapy.

Exercise

Behavioral

A 12-week supervised and progressive exercise program consisting of resistance training and aerobic exercise performed three times per week at the Rice University Wellness Center.

Primary outcomes

Change in Skeletal Muscle MassBaseline to 12 weeks

Change in skeletal muscle mass measured by dual-energy X-ray absorptiometry (DEXA).

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Rice University🇺🇸 Houston, Texas, United States