Recruiting

GLP-1 with Diet

Sponsor:

University of Texas at Austin

Code:

NCT07480109

Conditions

Obesity

Women (Between 30 to 60 Years Old)

Eligibility Criteria

Sex: Female

Age: 30 - 60

Healthy Volunteers: Accepted

Interventions

Protein Rich Foods

Study Details

Brief summary:

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.

Conditions

Obesity

Women (Between 30 to 60 Years Old)

Study ID

NCT07480109

Start date

Jun 1, 2026

Status verified date

Jun, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 30 - 60

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Protein Rich Foods

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.

Primary outcome measure

  • Body Composition [ Time Frame: Baseline and 12 weeks ]
  • Muscle Mass [ Time Frame: Baseline and 12 weeks ]
  • 3-day Average Daily Intake [ Time Frame: Baseline and 12 weeks ]

Central Contacts and Locations

Central contacts

Heather Leidy, PhD, FASN

5738252620Heather.Leidy@austin.utexas.edu

Locations

Dell Pediatric Research Center

Recruiting

Austin, Texas, United States, 78723

Contacts

Heather Leidy, PhD, FASN

573-825-2620Leidy.Lab@austin.utexas.edu

Principal Investigator:

Heather Leidy, PhD, FASN

More Information

Sponsor

University of Texas at Austin

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Keywords

  • GLP-1 Medication
  • Obesity
  • Increased Dietary Protein
  • Pork
  • satiety
  • D3 Creatine
  • breakfast
  • weight loss
  • sleep quality
  • muscle mass
  • eating behaviors
  • food noise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2026-06-09.