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Not yet recruitingNCT07554417Updated Apr 28, 2026

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

A Phase 4 interventional study of Semaglutide and Dietary Counseling in GLP - 1, Obesity & Overweight and Muscle Loss, sponsored by William Marsh Rice University. Not yet recruiting at 1 site in United States. Open to participants aged 40 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-04-28.

Sponsored by William Marsh Rice University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
40 Years to 55 Years
Sex
All
01

Study summary

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 receptor agonists. The primary objective of this study is to determine whether participation in a structured 12-week exercise program, in conjunction with individualized dietary counseling, preserves skeletal muscle mass and bone mineral density during GLP-1 therapy. Secondary objectives include assessing changes in muscular strength, cardiorespiratory fitness, and overall functional capacity. Findings from this study aim to inform best practices for integrating lifestyle interventions with pharmacological obesity treatments and to support safer, more effective, and functionally protective approaches to weight management in adults receiving GLP-1 therapy.

02

Conditions studied

  • GLP - 1
  • Obesity & Overweight
  • Muscle Loss
  • Exercise Intervention
  • Dietary Assessment

Keywords

  • GLP-1
  • Semaglutide
  • obesity
  • exercise intervention
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 20 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

William Marsh Rice University is the lead sponsor of 17 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    Control Arm: GLP-1 Therapy Alone

    Participants receive standard-of-care GLP-1 receptor agonist therapy (semaglutide) without additional exercise or dietary counseling.

    Drug: Semaglutide

  • Experimental
    Treatment Arm: GLP-1 Therapy + Exercise and Dietary Counseling

    Participants receive standard-of-care GLP-1 receptor agonist therapy (semaglutide) in combination with a 12-week structured exercise program and weekly individualized dietary counseling.

    Behavioral: Dietary Counseling · Behavioral: Exercise

Interventions

  • DrugSemaglutide

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

    Also known as: Wegovy®

  • BehavioralDietary Counseling

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

  • BehavioralExercise

    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.

06

What researchers measure

Primary outcomes

  1. Change in Skeletal Muscle Mass

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

    Time frame: Baseline to 12 weeks

07

Study locations

1 site
  • Rice University
    Houston, Texas 77005, United States
08

References and documents

Individual participant data

Plan to share: Yes — De-identified individual participant data will be shared. Shared IPD will include demographic characteristics (e.g., age, sex), baseline and post-intervention outcome measures related to body composition, muscle mass, bone mineral density, muscular strength, cardiorespiratory fitness, dietary intake summaries, and selected laboratory values. All shared data will be stripped of direct identifiers and coded to prevent re-identification. No names, dates of birth, contact information, medical record numbers, or other direct personal identifiers will be shared.

Supporting information: Study protocol, Icf, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07554417
Lead sponsor
William Marsh Rice University
Collaborators
The Methodist Hospital Research Institute
Responsible party
Sponsor
First posted
Apr 28, 2026
Start date
Apr 6, 2026 (estimated)
Primary completion
Jun 29, 2026 (estimated)
Completion
Aug 6, 2026 (estimated)
Last update
Apr 28, 2026

Study contacts

Anatolia Vick-Kregel
Contact
av82@rice.edu
17135157991

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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