Effect of Dietary Habits on Metabolic Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change in plasma insulin levels after standardized test meal
研究概览
简要总结
The goal of this application is to understand the connection between people's eating habits and the risk for developing diabetes, obesity, and cardiovascular disease.
详细描述
More than a third of U.S. adults are obese (BMI greater than 30), 8-12% of adults suffer from type 2 diabetes, and up to 30% of adults have pre-diabetes. Recent research studies have suggested that it is not just what we eat, but also when we eat that may put us at risk for obesity and type 2 diabetes. Skipping breakfast and eating late at night have been associated with an increased risk for obesity and type 2 diabetes (T2D), substantiated by recent animal and human experimental studies showing that altered meal timing itself, without changes in caloric intake, can influence weight regulation and impaired glucose tolerance. This research will determine in prediabetic and non-diabetic participants whether delaying meal times worsens glucose tolerance, leads to physiological changes favoring a positive energy balance, and increases caloric intake. This research will provide mechanistic insights into the metabolic consequences of changing meal timing and may help in evidence-based approaches to improve dietary interventions in the fight against obesity and T2D.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 25 and 37.9 kgm-2
- •Adults with regular sleep-wake timing
- •Non-smokers
- •Completion of medical and psychological screening tests
- •Able to spend 14 consecutive days in the sleep laboratory
排除标准
- •BMI < 25 or > 37.9 kgm-2
- •History of neurological or psychiatric disorder
- •History of sleep disorder or regular use of sleep-promoting medication
- •Current prescription, herbal, or over-the-counter medication use
- •Traveling across 2 or more time zones within past 3 months
- •Donating blood within past 8 weeks
- •Worked night or rotating shift work within past 3 years
- •Hearing impairment
- •Drug or alcohol dependency
结局指标
主要结局
Change in plasma insulin levels after standardized test meal
时间窗: During standardized meals scheduled on Days 3 and 6
Frequent blood samples
Change in circadian profile of plasma insulin levels
时间窗: During constant routine (Days 7-8)
Frequent blood samples
Change in circadian profile of plasma glucose levels
时间窗: During constant routine (Days 7-8)
Frequent blood samples
Change in plasma leptin levels across sleep/wake cycle
时间窗: During standardized meals scheduled on Days 3 and 6
Frequent blood samples
Change in circadian profile of plasma leptin
时间窗: During constant routine (Days 7-8)
Frequent blood samples
Change in glucose tolerance
时间窗: During standardized meals scheduled on Days 3 and 6
Frequent blood samples
次要结局
- Changes circadian rhythm in resting energy expenditure(During constant routine (Days 7-8))
- Change in insulin sensitivity, gene expression, epigenetic, lipidomic or proteomic markers from isolated adipocytes(On Day 5 of each protocol)
- Change in hunger and appetite, mood, and cognitive performance(Tests taken throughout the protocol, Days 1-9)
- Changes in microbiota, gene expression, epigenetic or proteomic markers(Throughout the protocol during Days 3 and 6, and during constant routine (Days 7-8))
- Change in circadian phase markers, such as from core body temperature, melatonin, cortisol(During constant routine (Days 7-8))
- Changes in sleep(Sleep will be measured during the night after Days 2 and 5)
研究者
Frank AJL Scheer, PhD
Frank AJL Scheer, PhD
Brigham and Women's Hospital