Increased Dietary Protein Intake During GLP-1 Medication Use (in Middle-aged Women With Overweight/Obesity)
Recruiting · NCT07480109 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Texas at Austin
View the official record on ClinicalTrials.gov →Interventions studied
Protein Rich Foods
What this trial is about
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.
Who can take part
Age range
30 Years to 60 Years
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed across 1 US state.
- Dell Pediatric Research Center - Austin, Texas, United States
- University of Texas at Austin - Austin, Texas, United States