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 — BEHAVIORAL
    For 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 + Protein
    The 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

Locations (2)

FacilityCityStateZIPSite coordinators
Dell Pediatric Research CenterAustinTexas78723
Heather Leidy, PhD, FASN
573-825-2620
Heather Leidy, PhD, FASN (PRINCIPAL_INVESTIGATOR)
University of Texas at AustinAustinTexas78723
Heather Leidy, PhD
5738252620

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