Westlake Personalized Nutrition Intervention Study: N-of-1 Trials for Dietary Macronutrient Intake
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Blood glucose profiling
研究概览
简要总结
This is a dietary intervention study in students and staff of Westlake University, which is designed to provide evidence in support of N-of-1 methods as an approach to advance personalized nutrition. The primary aim is using a series of N-of-1 trials to determine the impacts of a high fat, low carbohydrate diet (HF-LC) on glucose metabolism and gut microbiota in subjects versus a low fat, high carbohydrate diet (LF-HC) at both the individual and group level.
详细描述
This study will employ a series of individual N-of-1 trials comparing a high fat, low carbohydrate diet (HF-LC) to a low fat, high carbohydrate diet (LF-HC). Participants will enter the study on a usual diet and will have a 6-day run in period for diet planning and baseline data collection before beginning their intervention. The HF-LC or the LF-HC will be randomized as the starting intervention followed by a wash-out period lasting for 6 days with normal diet between two interventions to eliminate previous intervention effects. Then the participants will be provided with the other diet. Both HF-LC and LF-HC last for 6 days in each set which consists of two wash-out periods and two intervention periods. There will be 3 sets in this study and investigators will aggregate the results of the completed N-of-1 trials across all participants to estimate the group level impacts of HF-LC compared to LF-HC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willingness and capability to complete the study protocol
排除标准
- •Inability or unwillingness to approved to provide informed consent
- •Neurological conditions that might affect the assessment of the study measurement
- •Hospitalization or surgery planned within 3 months
- •Gastrointestinal diseases
- •Other serious medical conditions, such as liver, kidney, or systemic disease
- •Women who are pregnant or lactating
- •Tobacco, alcohol, or illicit drug abuse
- •Had taken antibiotics in the past two weeks prior to the start of the trial
- •Participants on a vegan diet
- •Any food allergy
- •Lack of smart phone and data plan for participating caregiver
- •Non-Chinese speaking participants
- •Participating in another concurrent intervention study
结局指标
主要结局
Blood glucose profiling
时间窗: Day 7-12 and day 19-24 of each set
Glucose levels will be recorded by continuous glucose monitoring over the intervention periods.
Postprandial blood glucose change
时间窗: Day 7-12 and day 19-24 of each set
Postprandial blood glucose from different foods will be assessed.
次要结局
未报告次要终点