Increased Dietary Protein Intake During GLP-1 Medication Use (in Middle-aged Women With Overweight/Obesity)

March 14, 2026 updated by: Heather Leidy, University of Texas at Austin

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78723
      • Austin, Texas, United States, 78723
        • Dell Pediatric Research Center
        • Contact:
        • Principal Investigator:
          • Heather Leidy, PhD, FASN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 12 weeks
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.
Baseline and 12 weeks
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.
Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Energy Expenditure and Sleep
Time Frame: Baseline and 12 weeks
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.
Baseline and 12 weeks
Food Noise
Time Frame: Baseline, 2 week, 4 week, 6 week, 8 week, 10 week, 12 weeks
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.
Baseline, 2 week, 4 week, 6 week, 8 week, 10 week, 12 weeks
Depression
Time Frame: Baseline and 12 weeks
Participants will complete the Patient Health Questionnaire-9 (PHQ-9). 9-item screening tool for depression. Higher scores indicate increased depression severity.
Baseline and 12 weeks
Anxiety
Time Frame: Baseline and 12 weeks
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.
Baseline and 12 weeks
Pork Consumption
Time Frame: Baseline and 12 weeks
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."
Baseline and 12 weeks
Appetite, Satiety, Food Craving and Mood
Time Frame: Baseline and 12 weeks
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."
Baseline and 12 weeks
Control of Eating
Time Frame: Baseline and 12 weeks
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.
Baseline and 12 weeks
Health and Well-being Questionnaire
Time Frame: Baseline and 12 weeks
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.
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas at Austin

Collaborators

National Pork Board

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

March 14, 2026

First Submitted That Met QC Criteria

March 14, 2026

First Posted (Actual)

March 18, 2026

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 14, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FP00012519

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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