Obesity, Women (Between 30 to 60 Years Old)
Conditions
Keywords
GLP-1 Medication, Obesity, Increased Dietary Protein, Pork, satiety, D3 Creatine, breakfast, weight loss, sleep quality, muscle mass, eating behaviors, food noise
Brief 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. 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.
Interventions
BEHAVIORALProtein 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.
Sponsors
University of Texas at Austin
National Pork Board
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Composition | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Energy Expenditure and Sleep | 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. |
| Food Noise | 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. |
| Depression | 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. |
| Anxiety | 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. |
| Pork Consumption | 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." |
| Appetite, Satiety, Food Craving and Mood | 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." |
| Control of Eating | 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. |
| Health and Well-being Questionnaire | 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. |
Countries
United States
Contacts
CONTACTHeather Leidy, PhD, FASN
Outcome results
None listed