Dietary Intervention to Mitigate Adverse Consequences of Night Work
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in glucose tolerance from Baseline to Test Day
研究概览
简要总结
The goal of this clinical trial is to test whether our dietary intervention can prevent or lessen the negative health effects of night shift work in healthy participants.
Participants will:
- complete 2 inpatient stays
- be provided with identical meals
- have frequent blood draws
- provide urine, saliva, stool and rectal swab samples
详细描述
Shift work increases the risk for diabetes possibly due to the adverse metabolic effects of circadian misalignment. As shift work is not foreseen to disappear, the development of individually-targeted therapies for metabolic health in these vulnerable shift workers is urgently needed. This research will determine whether our dietary intervention can mitigate the adverse metabolic effects of circadian misalignment, which may help in the design of evidence-based dietary interventions to improve the metabolic health in shift workers.
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
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-45 yr old
- •BMI 20.0-29.9
- •European/Hispanic/African-American ancestry
- •No acute, chronic or debilitating medical conditions (e.g. metabolic, cardiovascular, respiratory, neurological, cancers, etc.)
排除标准
- •Currently smoking/vaping or 5 or more years of smoking/vaping
- •History of drug or alcohol dependency
- •History of psychiatric illness or disorder
结局指标
主要结局
Change in glucose tolerance from Baseline to Test Day
时间窗: Baseline (Day 2) and Test Day (Day 4)
Change in incremental glucose area under the curve (AUC) from a mixed meal test.
Changes in microbial community structure/composition/function of oral and gut microbiome from Baseline to Test Day
时间窗: Baseline (Day 2) and Test Day (Day 4)
Shotgun metagenomics sequencing or 16S rRNA sequencing of saliva, stool, and rectal swab samples will provide in-depth interrogation of the microbial community structure, composition, and function.
次要结局
- Change in levels of serum markers of gut microbiota from Baseline to Test Day(Baseline (Day 2) and Test Day (Day 4))
- Change in level of serum markers of inflammatory state from Baseline to Test Day(Baseline (Day 2) and Test Day (Day 4))
- Change in insulin sensitivity (Oral Minimal Model method) from Baseline to Test Day(Baseline (Day 2) and Test Day (Day 4))
- Change in levels of serum markers of intestinal barrier integrity from Baseline to Test Day(Baseline (Day 2) and Test Day (Day 4))
研究者
Frank AJL Scheer, PhD
Professor
Brigham and Women's Hospital