Recruiting

GLP-1 vs. Lifestyle

Sponsor:

Texas Tech University

Code:

NCT07740291

Conditions

Obesity & Overweight

Cardiometabolic Health Indicators

Addiction

Eating Disorders

Mental Health

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

GLP-1 Receptor Agonist Therapy

Structured Lifestyle Intervention

Study Details

Brief summary:

This study examines how two different weight-loss strategies affect heart and metabolic health, as well as changes at the molecular level in the body. One group includes adults who are starting a GLP-1 receptor agonist medication (i.e., semaglutide or tirzepatide) prescribed by their own doctor for weight loss. The other group includes adults who will participate in a structured lifestyle program combining a reduced-calorie diet with increased physical activity. Both groups complete assessments at the start of the study and again after three months.

At each visit, participants have their weight, body composition, blood pressure, and resting metabolic rate measured. A blood draw is collected to evaluate cholesterol, blood sugar, insulin, appetite hormones, and liver and kidney function markers, and to analyze gene activity (RNA sequencing) and metabolites, which are small molecules that reflect how the body is using energy and nutrients. Participants also complete online questionnaires about diet, disordered eating, stress, mental health, and quality of life. Those in the lifestyle group attend three individual nutrition and physical activity counseling sessions over the course of the study.

The main goals of the study are (1) to determine whether GLP-1 receptor agonist medication or lifestyle changes produce greater improvements in heart and metabolic health markers over three months; (2) to examine if GLP-1 receptor agonist medication or lifestyle changes produce greater improvement in disordered eating, stress, mental health, and quality of life; (3) to investigate if GLP-1 receptor agonist medication or lifestyle changes produce greater improvement in appetite-related hormones (i.e., ghrelin, GLP-1, insulin, leptin, and peptide YY); and (4) to explore whether the two approaches cause different changes in gene expression and metabolic profiles. This is a pilot study conducted at Texas Tech University's Nutrition and Metabolic Health Initiative clinic in Lubbock, Texas.

Who can participate: Adults aged 18 years and older with a BMI of 27.5 or higher who are either starting semaglutide or tirzepatide therapy for weight management or who are seeking weight management without the use of weight-loss medications.

Who cannot participate: Individuals who are pregnant or lactating, have a pacemaker or internal medical device, have certain serious medical conditions (such as active cancer, uncontrolled hypertension, or severe kidney disease), have type 1 diabetes, or use insulin for type 2 diabetes.

Conditions

Obesity & Overweight

Cardiometabolic Health Indicators

Addiction

Eating Disorders

Mental Health

Study ID

NCT07740291

Start date

Jan 2, 2025

Status verified date

Jul, 2026

Completion date

Dec 7, 2026

Anticipated

Primary completion date

Nov 23, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age 18 years or older
  • BMI of 27.5 kg/m2 or higher
  • For GLP-1 RA arm: initiating semaglutide or tirzepatide for weight loss as prescribed by their own medical provider
  • For LS comparator arm: not currently taking a GLP-1 receptor agonist or other weight-loss medication, and no use of weight-loss medication within the past 3 months

Exclusion Criteria:

  • Pregnant
  • Breastfeeding
  • Wears a pacemaker or other internal medical device
  • Chronic kidney disease in the past 2 years
  • Active cancer or cancer treatment within the past 6 months
  • Current diagnosis of any major endocrine, inflammatory, cardiovascular, or neurological disorder/condition, including Addison's disease, autism, congestive heart failure, Crohn's disease, Cushing's syndrome, hyperparathyroidism, multiple sclerosis, neuromuscular disorders (Guillain-Barre syndrome or myasthenia gravis), stroke, thyroid gland disorders (hyperthyroidism or hypothyroidism), type 1 diabetes, and ulcerative colitis
  • Insulin therapy for type 2 diabetes
  • For LS comparator arm only: initiating any weight-loss medication (including a GLP-1 receptor agonist) currently or within the past 3 months

Study Design

Enrollment

27 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: GLP-1 Receptor Agonist (Semaglutide or Tirzepatide)

Individuals in this study arm will be prescribed semaglutide or tirzepatide for weight management by their primary medical provider. Individuals will be invited to enroll in the study if they are starting semaglutide or tirzepatide within 0-3 days of coming into the NMHI clinic for their baseline assessment.

active comparator: Lifestyle Comparator Arm

Participants receive a structured lifestyle intervention delivered by a nutritional sciences graduate student and developed by a Registered Dietitian. The intervention targets a 500 kcal daily deficit from measured total energy expenditure and 150 to 300 minutes of moderate-intensity physical activity per week. Three individual education sessions are provided at baseline, one month, and two months. Dietary adherence is monitored via MyFitnessPal or a food journal. The same physical assessments and biospecimen collection procedures as the GLP-1 RA arm are completed at baseline and three months.

Interventions

GLP-1 Receptor Agonist Therapy

Participants receive semaglutide or tirzepatide as prescribed by their own medical provider prior to study enrollment. Dosing and titration followed the prescribing provider's clinical judgment and are not controlled by the study team. Both medications are GLP-1 receptor agonists approved for weight management and glycemic control; tirzepatide additionally acts on the glucose-dependent insulinotropic polypeptide (GIP) receptor.

Structured Lifestyle Intervention

A reduced-calorie diet providing a 500 kcal daily deficit from individually calculated total energy expenditure, combined with a goal of 150 to 300 minutes of moderate-intensity physical activity per week. Total energy expenditure is estimated by multiplying each participant's measured resting metabolic rate (MedGem indirect calorimetry) by a standard physical activity factor. Meal plans are based on the Academy of Nutrition and Dietetics Nutrition Care Manual. Three individual counseling sessions are delivered over three months in person or via a HIPAA-secured video platform.

Primary outcome measure

  • Change in Fasting Blood Glucose [ Time Frame: Baseline and 3 months ]
  • Change in LDL Cholesterol [ Time Frame: Baseline and 3 months ]
  • Change in Triglycerides [ Time Frame: Baseline and 3 months ]
  • Change in Fasting Insulin [ Time Frame: Baseline and 3 months ]
  • Change in Blood Pressure [ Time Frame: Baseline and 3 months ]
  • Change in Disordered Eating [ Time Frame: Baseline and 3 months ]
  • Change in Food Addiction [ Time Frame: Baseline and 3 months ]
  • Change in Alcohol Use [ Time Frame: Time Frame: Baseline and 3 months ]
  • Change in Substance Use [ Time Frame: Time Frame: Baseline and 3 months ]
  • Change in Depressive Symptoms and Suicidal Ideation [ Time Frame: Time Frame: Baseline and 3 months ]
  • Change in Anxiety [ Time Frame: Baseline and 3 months ]
  • Change in Perceived Stress [ Time Frame: Baseline and 3 months ]
  • Change in Fatigue [ Time Frame: Baseline and 3 months ]

Central Contacts and Locations

Locations

Nutrition Metabolic Health Initiative (NMHI)

Recruiting

Lubbock, Texas, United States, 79410

Contacts

Shannon Dr. Galyean, PhD

+18068342286Shannon.Galyean@ttu.edu

More Information

Sponsor

Texas Tech University

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Keywords

  • GLP-1 receptor agonists
  • obesity
  • Multi-omics profiling
  • Semaglutide
  • Tirzepatide
  • Appetite Regulation
  • Addictive Behaviors
  • eating disorders
  • appetite-related hormones
  • mental health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Texas Tech University on 2026-07-31. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.