Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT07480109

Recruiting nowNot applicableInterventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age30 Years to 60 Years

SexFemale

Healthy volunteersAccepted

ConditionObesity, Women (Between 30 to 60 Years Old)

Full registry 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

Treatments and study arms

Protein Rich Foods

Behavioral

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 outcomes

Body CompositionBaseline 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 MassBaseline 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 IntakeBaseline 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.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Dell Pediatric Research Center🇺🇸 Austin, Texas, United States

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Heather Leidy, PhD, FASNContact

Email · Call 573-825-2620

Heather Leidy, PhD, FASNPrincipal Investigator

University of Texas at Austin🇺🇸 Austin, Texas, United States

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Heather Leidy, PhDContact

Email · Call 5738252620