ObesityNCT07480109
Increased Dietary Protein Intake During GLP-1 Medication Use (in Middle-aged Women With Overweight/Obesity)
A study testing Protein Rich Foods in people with Obesity and Women (Between 30 to 60 Years Old), run by University of Texas at Austin at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Women (Between 30 to 60 Years Old)
- What is being tested?
- Protein Rich Foods
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Dell Pediatric Research Center
Austin, Texas, 78723
Heather Leidy, PhD, FASN, 573-825-2620, Leidy.Lab@austin.utexas.edu
Heather Leidy, PhD, FASN
- Not yet recruiting
University of Texas at Austin
Austin, Texas, 78723
Heather Leidy, PhD, 5738252620, heather.leidy@austin.utexas.edu
About this study
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)
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.
Read the 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.
- Conditions
- Obesity, Women (Between 30 to 60 Years Old)
- Being tested
- Protein Rich Foods
- Keywords
- GLP-1 Medication, Obesity, Increased Dietary Protein, Pork, satiety, D3 Creatine, breakfast, weight loss, sleep quality, muscle mass, eating behaviors, food noise
- Medical subject headings
- Obesity, Weight Loss, Sleep Initiation and Maintenance Disorders, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein Rich FoodsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| GLP-1 Only (no dietary intervention) | No 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. |
| GLP-1 + Protein | Experimental | 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. Receives: Behavioral: Protein Rich Foods |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and 12 weeks
Secondary outcomes (8)
Energy Expenditure and Sleep
Free-living sleep will be measured for 7 days through actigraphy. The device will be worn continuously on the wrist over a period of 7 days for measures of energy expenditure, resting periods, steps, sleep quality, and latency. Sleep quality and patterns will also be assessed using sleep diaries and questionnaires.
Measured: Baseline and 12 weeks
Food Noise
Questionnaires assessing Food Noise will be completed: Food Noise Questionnaire (FNQ) and Ro Allison Dhurandhar Food Noise Inventory (RAID-FN). Higher scores indicate higher presence of food noise.
Measured: Baseline, 2 week, 4 week, 6 week, 8 week, 10 week, 12 weeks
Depression
Participants will complete the Patient Health Questionnaire-9 (PHQ-9). 9-item screening tool for depression. Higher scores indicate increased depression severity.
Measured: Baseline and 12 weeks
Anxiety
Participants will complete the Generalized Anxiety disorder (GAD) questionnaire which is a 7-item screening tool for generalized anxiety disorder. The questions assess whether various anxiety symptoms have been experienced and how frequently they occurred over a two-week period. Higher scores indicate increased anxiety severity.
Measured: Baseline and 12 weeks
Pork Consumption
During a breakfast challenge meal in the laboratory, participants will be provided with specific breakfast foods (i.e., fruit, starchy vegetables, eggs) to consume over a 20 min period. In addition, they will be provided with fresh, minimally processed pork sausage to consume ad libitum during the meal. The pork will be weighed before and after breakfast to assess pork consumption. Questionnaires assessing pork palatability (i.e., appearance, aroma, flavor, texture, overall liking) and appetite/satiety (i.e., hunger, fullness, desire to eat) will collected throughout the breakfast meal. The questionnaires contain VAS incorporating a 100mm horizontal line rating scale for each response. The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely."
Measured: Baseline and 12 weeks
Appetite, Satiety, Food Craving and Mood
In a free-living environment, participants will be provided with pork breakfast or no pork breakfasts, on separate days. Questionnaires assessing appetitive sensations (i.e., hunger, fullness, desire to eat, prospective food consumption) food cravings (sweet, savory-fat), and mood (sleepy, energy, nauseous) will be collected throughout the day. The questionnaires contain VAS incorporating a 100mm horizontal line rating scale for each response. The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely."
Measured: Baseline and 12 weeks
Control of Eating
Participants will complete the Control of Eating Questionnaire (CoEQ) which is a 21-item survey that measures severity and type of food cravings an individual experiences over a pre-defined time period.
Measured: Baseline and 12 weeks
Health and Well-being Questionnaire
Participants will complete the Short Form 36 Health Survey (SF-36v2) which is a 36-item questionnaire that measures health related quality of life. 8 domains captured: physical functioning, physical and emotional limitations, social functioning, bodily pain, general and mental health that are designed to capture an individual's perceptions on their health and well-being.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 Jun 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- National Pork Board
- Responsible party
- Principal investigator, Heather Leidy, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480109
- Sponsor's protocol ID
- FP00012519
- Status last verified
- Jun 2026
- First submitted
- 14 Mar 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07480109
- Acronym / sponsor ID
- FP00012519
- Conditions
- Obesity, Women (Between 30 to 60 Years Old)
- Keywords
- GLP-1 Medication, Obesity, Increased Dietary Protein, Pork, satiety, D3 Creatine, breakfast, weight loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- National Pork Board
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| GLP-1 Only (no dietary intervention) | No 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. |
| GLP-1 + Protein | Experimental | Behavioral: Protein Rich FoodsThe 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein Rich FoodsFor 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. | Behavioural | GLP-1 + Protein |
Primary outcome
Body Composition
Time frame: Baseline and 12 weeks
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.
Muscle Mass
Time frame: Baseline and 12 weeks
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.
3-day Average Daily Intake
Time frame: Baseline and 12 weeks
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein Rich Foods in people with Obesity and Women (Between 30 to 60 Years Old), run by University of Texas at Austin at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather Leidy, PhD, FASN (5738252620, Heather.Leidy@austin.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Composition (time frame: Baseline and 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.