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NCT07480109NARecruitingAccepts Healthy Volunteers

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

University of Texas at Austin

Start Date

6/1/2026

Completion Date

9/30/2027

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.

Detailed Description

Middle-aged women with (overweight/)obesity who will begin or have begun GLP-1 medication use will be recruited to complete a 12-week, parallel-design, dietary protein intervention trial. The participants will be randomized into the following groups: GLP-1 ONLY (no dietary intervention) or GLP-1 + Protein. The GLP-1 only group will take/continue to take the respective GLP-1 medication as prescribed by their physician, whereas 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. Baseline and post-study assessments include body composition, eating behavior, food intake, appetite, satiety, food cravings, food reward, and health \& well-being.

Eligibility Criteria

Age Range: 30 years to 60 years

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

Interventions

BEHAVIORAL

Protein Rich Foods

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Conditions

ObesityWomen (Between 30 to 60 Years Old)

Locations

Dell Pediatric Research Center

Austin, Texas 78723

United States

University of Texas at Austin

Austin, Texas 78723

United States