Ghrelin Regulation and Structure: Effect of Diet Composition on Ghrelin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- The primary outcomes for aim 1 are the suppression of total and acylated ghrelin from peak fasting (highest value) level to nadir (lowest level) during the 4 hours after each meal, comparing the obese to the lean subjects.
研究概览
简要总结
The purpose of this study is to learn more about how diet affects the hormone ghrelin. Ghrelin is made in the stomach and causes appetite to increase. Learning about ghrelin will help the investigators understand more about obesity.
详细描述
Control subjects will be provided 3 different diets for 2 weeks each. At the end of each diet period participants will be admitted to OHSU Clinical Translation Research Center (CTRC) for blood sampling every 30 minutes for 13.5 hours, to measure levels of hormones. Participants will also have a DXA scan to measure body composition.
PWS subjects will have one admission after eating a standardized diet prepared by caregivers for 2 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 or older.
- •Weight stable for at least 3 months.
- •At lifetime maximal body weight.
排除标准
- •Actively losing weight by diet or exercise.
- •Alcohol consumption > 2 drinks per day.
- •Exercise > 30 minutes 3 times a week.
- •Prescription drug use (except birth control pills, vitamins, or minerals).
- •Type 2 diabetes.
- •Heart disease, cancer, malabsorptive states, or chronic infections that would affect body weight.
- •Weight > 300 lbs (exceeds the weight limit of the DEXA machine).
- •Hemoglobin < 12.0 g/dL for women, < 13.5 g/dL for men
结局指标
主要结局
The primary outcomes for aim 1 are the suppression of total and acylated ghrelin from peak fasting (highest value) level to nadir (lowest level) during the 4 hours after each meal, comparing the obese to the lean subjects.
时间窗: every 8 weeks
次要结局
- Area-under-the-curve measurements during the 12 ½ hours of testing for ghrelin and other nutrient and gut-peptides, including glucose, insulin, PYY3-36, and active GLP-1.(Every 8 weeks)