Increased Dietary Protein Intake During GLP-1 Medication Use (in Middle-aged Women With Overweight/Obesity)
Purpose
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)
Eligibility
- Eligible Ages
- Between 30 Years and 60 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- 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.
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Austin, Texas 78723
More Details
- Status
- Recruiting
- Sponsor
- University of Texas at Austin
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.