The Effect of Protein and Omega-3 Fatty Acid Supplementation on Body Composition, Sleep, Cardiometabolic Health and Strength in Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Sleep Quality
研究概览
简要总结
The purpose of the research is to determine if protein and omega-3 fatty acid supplementation improve sleep, improve body composition, and improve markers of metabolic health in postmenopausal women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 85 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal women (12+ months following last reported menstrual cycle)
排除标准
- •food allergies
- •diet restrictions
- •do not habitually eat breakfast
- •picky eaters\regularly consume protein or omega-3 related supplements
- •consume omega-3 fatty acid rich fish (tuna, salmon, etc.) greater than two times per month -have any other diet-related conditions that would prevent them from consuming whey protein supplements and/or omega-3 fatty acid supplements
- •habitual alcohol consumption (> 4 drinks/week)
- •medication impacting appetite or metabolism
- •Lipid or blood pressure lowering medication
- •Hormone replacement therapy
结局指标
主要结局
Sleep Quality
时间窗: Change in sleep quality from baseline (day 0) to 16 weeks.
Pittsburgh Sleep Quality Index (PSQI) will assess sleep quality and disturbance. This is a elf-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
次要结局
- Resting energy expenditure (REE)(On day 1 and day 112 (final day of 16-week intervention) of study.)
- Dietary intake(Change in dietary intake from baseline (day 0) to 16 weeks.)
- Orexin(On day 1 and day 112 (final day of 16-week intervention) of study.)
- Sleep Quantity(Change in sleep quantity from baseline (day 0) to 16 weeks.)
- Body composition(On day 1 and day 112 (final day of 16-week intervention) of study.)
研究者
Jamie Baum
Associate Professor
University of Arkansas, Fayetteville