Increased Dietary Protein Intake During GLP-1 Medication Use (in Middle-aged Women With Overweight/Obesity)
Part of paid clinical trials in Austin, Texas.
- Sponsor
- University of Texas at Austin
- Study ID
- NCT07480109
- Status
- Recruiting
Conditions
- Obesity
- Women (Between 30 to 60 Years Old)
Eligibility Criteria
- Sex
- FEMALE
- Age
- 30 Years - 60 Years
- Healthy Volunteers
- Accepted
Interventions
- Protein Rich Foods — BEHAVIORALFor 12 weeks, the participants will either receive a variety of pork-based protein-rich foods, or will continue to eat their habitual diet without any dietary intervention.
Study Details
Middle-aged women with (overweight/)obesity who will begin or have begun GLP-1 medication use will be recruited to complete a 12-week diet intervention study. For 12-weeks, participants will continue to take their GLP-1 medication and may be provided with protein-rich foods to consume every day. Body composition, eating behavior, health, and well-being will be measured before and after the study.
Key Dates
- Start date
- Jun 1, 2026
- Status verified
- Jun 2026
- Primary completion
- Jun 1, 2027
- Completion
- Sep 30, 2027
Study Design
- Enrollment
- 75 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- No Intervention: GLP-1 Only (no dietary intervention)The participants in the GLP-1 only group will take/continue to take the respective GLP-1 medication as prescribed by their physician. They will not receive a dietary intervention.
- Experimental: GLP-1 + ProteinThe participants in the GLP-1 + Protein group will take/continue to take the respective GLP-1 medication as prescribed by their physician but will be provided with a variety of protein-rich pork foods to yield 20 g of protein, twice daily, for 12 weeks, totaling \~40 g high quality protein. In addition, recipes will be provided to support the consumption of the protein-rich foods within the breakfast meal (required) and in other eating occasions.
Primary Outcome Measure
Body Composition [ Time Frame: Baseline and 12 weeks ]
Central Contacts
- Heather Leidy, PhD, FASN5738252620
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Dell Pediatric Research Center | Austin | Texas | 78723 | Heather Leidy, PhD, FASN (PRINCIPAL_INVESTIGATOR) |
| University of Texas at Austin | Austin | Texas | 78723 |
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