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

The University of Texas System (UT)

Status: Begins enrollment this month

Conditions: Women (Between 30 to 60 Years Old); Obesity

Treatments: Behavioral: Protein Rich Foods

Study type: Interventional

Funder types: Other

Identifiers

NCT07480109

FP00012519

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: Female

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 2 patient groups

GLP-1 Only (no dietary intervention)

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Protein Rich Foods