Increased Dietary Protein Intake During GLP-1 Medication Use (in Middle-aged Women With Overweight/Obesity)
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)
1 other identifier
interventional
75
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Jun 2026
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2026
CompletedFirst Posted
Study publicly available on registry
March 18, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
June 9, 2026
June 1, 2026
1 year
March 14, 2026
June 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Body Composition
Whole body total, fat, and fat free mass will be determined with Dual X-ray Absorptiometry (DXA). The DXA uses a linear X-ray fan beam with switched-pulse dual-energy and a multi-element detector array. The whole body scan takes \<1.8 sec with radiation exposure of 0.01mGy.
Baseline and 12 weeks
Muscle Mass
D3-creatine method determines muscle mass by measuring the total-body creatine pool size through isotope dilution. Participants will ingest 30 mg of D3-creatine powder dissolved in water. Following consumption, three spot urine samples will be collected at 24-, 48-, and 72-hours using study supplies.
Baseline and 12 weeks
3-day Average Daily Intake
Free-living energy intake, portion sizes, and eating patterns will be assessed using 3 24-h dietary recalls will be collected via a phone intervention or using the computerized ASA24 (Automated Self-administered 24-hour Dietary Assessment Tool) program. The participants will recall everything consumed (beverages and foods) over the previous day.
Baseline and 12 weeks
Secondary Outcomes (8)
Energy Expenditure and Sleep
Baseline and 12 weeks
Food Noise
Baseline, 2 week, 4 week, 6 week, 8 week, 10 week, 12 weeks
Depression
Baseline and 12 weeks
Anxiety
Baseline and 12 weeks
Pork Consumption
Baseline and 12 weeks
- +3 more secondary outcomes
Study Arms (2)
GLP-1 Only (no dietary intervention)
NO INTERVENTIONThe 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.
GLP-1 + Protein
EXPERIMENTALThe 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
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Texas at Austinlead
- National Pork Boardcollaborator
Study Sites (2)
Dell Pediatric Research Center
Austin, Texas, 78723, United States
University of Texas at Austin
Austin, Texas, 78723, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 14, 2026
First Posted
March 18, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
September 30, 2027
Last Updated
June 9, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share