Increased Dietary Protein Intake During GLP-1 Medication Use (in Middle-aged Women With Overweight/Obesity)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-60
SponsorUniversity of Texas at Austin
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Protein Rich Foods
BehavioralFor 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.
Treatment groups
75 Participants
are divided into 2 treatment groupsGroup A: GLP-1 Only (no dietary intervention)No intervention 0 interventions
Group B: GLP-1 + ProteinExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and 12 weeks2
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.
Time frame
Baseline and 12 weeks3
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.
Time frame
Baseline and 12 weeksSecondary outcomes
1
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.
Time frame
Baseline and 12 weeks2
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.
Time frame
Baseline, 2 week, 4 week, 6 week, 8 week, 10 week, 12 weeks3
Depression
Participants will complete the Patient Health Questionnaire-9 (PHQ-9). 9-item screening tool for depression. Higher scores indicate increased depression severity.
Time frame
Baseline and 12 weeks4
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.
Time frame
Baseline and 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Texas at Austin
Lead sponsor
National Pork Board
Collaborator
Source ClinicalTrials.gov