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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Body Composition
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
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.
干预措施: Protein Rich Foods (Behavioral)
结局指标
主要结局
Body Composition
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Energy Expenditure and Sleep(Baseline and 12 weeks)
- Food Noise(Baseline, 2 week, 4 week, 6 week, 8 week, 10 week, 12 weeks)
- Depression(Baseline and 12 weeks)
- Anxiety(Baseline and 12 weeks)
- Pork Consumption(Baseline and 12 weeks)
- Appetite, Satiety, Food Craving and Mood(Baseline and 12 weeks)
- Control of Eating(Baseline and 12 weeks)
- Health and Well-being Questionnaire(Baseline and 12 weeks)
研究者
Heather Leidy
Professor
University of Texas at Austin