Increased Dietary Protein Intake During GLP-1 Medication Use (in Middle-aged Women With Overweight/Obesity)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Protein Rich Foods.
- Who it may be relevant to
- Registry conditions: Obesity, Women (Between 30 to 60 Years Old). Basic parameters: 30 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The 'Power of Pork Protein' (From Diverse Pork Products) to Promote Health and Well-being During GLP-1 Medication Use in Middle-aged Women (With Overweight/Obesity)
Overview
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.
Interventions
- Behavioral 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 measures
- 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]
Secondary outcome measures (8)
- Energy Expenditure and Sleep [Time frame: Baseline and 12 weeks]
- Food Noise [Time frame: Baseline, 2 week, 4 week, 6 week, 8 week, 10 week, 12 weeks]
- Depression [Time frame: Baseline and 12 weeks]
- Anxiety [Time frame: Baseline and 12 weeks]
- Pork Consumption [Time frame: Baseline and 12 weeks]
- Appetite, Satiety, Food Craving and Mood [Time frame: Baseline and 12 weeks]
- Control of Eating [Time frame: Baseline and 12 weeks]
- Health and Well-being Questionnaire [Time frame: Baseline and 12 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Dell Pediatric Research Center — Austin
- University of Texas at Austin — Austin
Identifiers
NCT: NCT07480109 · FP00012519