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Dietary Protein Intake with GLP-1 Medication for Women with Overweight/Obesity

This study is looking at whether eating more protein-rich foods helps middle-aged women (30-60 years old) who are taking GLP-1 medication for overweight or obesity. You would either continue your usual diet or receive pork-based protein-rich foods to eat daily for 12 weeks, while still taking your GLP-1 medication. Researchers will measure changes in your body composition (how much fat and muscle you have), muscle mass, and daily food intake to see if the protein-rich diet makes a difference. The study aims to enroll 75 participants, but its current status is unclear.

Study design
This is an interventional study where 75 participants will be randomly assigned to one of two groups: GLP-1 medication only or GLP-1 medication plus protein-rich foods.
What's involved
You would participate for 12 weeks, continuing your GLP-1 medication and potentially receiving protein-rich foods. Assessments of body composition, muscle mass, and food intake will be done at the beginning and end of the 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your body composition, muscle mass, and food intake will be measured at the end of the 12-week study period.

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NCT07480109

Increased Dietary Protein Intake During GLP-1 Medication Use (in Middle-aged Women With Overweight/Obesity)

Recruiting
NAAges 30–60InterventionalTreatment
University of Texas at Austin
~75 participants
Updated 2026-06-09 on ClinicalTrials.gov
What's tested:Protein Rich Foods

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Body Composition
Measured over Baseline and 12 weeks
+2 more outcomes measured

Conditions

Obesity
Women (Between 30 to 60 Years Old)

Explore related trials

Obesity

Where it's being run

2 sites across 1 states
Texas2

Who to contact

Heather Leidy, PhD, FASN
[email protected]
5738252620
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adult women (30-60 years)
Having overweight or obesity (BMI \>25 kg/m2)
Prescribed or taking GLP-1 medicine (within 4 weeks) by a physician
Willing and able to maintain current inactivity patterns throughout the study
Willing and able to follow all study procedures
Generally healthy, as assessed from the medical history questionnaire

Exclusion

Adults (\<30 years or \>60 years)
Having normal weight (BMI \<25 kg/m2)
Not prescribed GLP-1 medication by a physician
Those on GLP-1 medication longer than 4 weeks (during time of screening)
Currently on a high-protein or other specific diet
Unwilling and/or unable to maintain current inactivity patterns throughout the study
Unwilling and/or unable to follow all study procedures
Unwilling and/or unable to eat pork (for the GLP-1 + Protein group)
Not generally healthy, as assessed from the medical history questionnaire

What this trial measures

  • Body CompositionBaseline and 12 weeks

    Whole body total, fat, and fat free mass will be determined with Dual X-ray Absorptiometry (DXA). The DXA uses a linear X-ray fan beam with switched-pulse dual-energy and a multi-element detector array. The whole body scan takes \<1.8 sec with radiation exposure of 0.01mGy.

  • Muscle MassBaseline and 12 weeks

    D3-creatine method determines muscle mass by measuring the total-body creatine pool size through isotope dilution. Participants will ingest 30 mg of D3-creatine powder dissolved in water. Following consumption, three spot urine samples will be collected at 24-, 48-, and 72-hours using study supplies.

  • 3-day Average Daily IntakeBaseline and 12 weeks

    Free-living energy intake, portion sizes, and eating patterns will be assessed using 3 24-h dietary recalls will be collected via a phone intervention or using the computerized ASA24 (Automated Self-administered 24-hour Dietary Assessment Tool) program. The participants will recall everything consumed (beverages and foods) over the previous day.