Westlake Personalized Nutrition Intervention Study: N-of-1 Trials for Dietary Macronutrient Intake 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Blood glucose profiling
研究概览
简要总结
Diet and nutrition are key to maintain human health. Westlake N-of-1 Trials for Macronutrient Intake (WE-MACNUTR) trial investigates individualized postprandial glycemic responses to different proportions of dietary fat and carbohydrates intake using an n-of-1 experimental study design. The experimental diets are isocaloric high fat, low carbohydrate (HF-LC) or low fat, high carbohydrate (LF-HC). With standardized intervention and strictly controlled eating behaviors, the WE-MACNUTR study identifies specific HC-responders and HF-responders in terms of postprandial glucose response.
This is a follow-up study offered to participants who have completed the WE-MACNUTR study in 2019. Volunteers will be asked to participate in four 5-d periods while wearing glucose monitors (Abbott Freestyle Libre) with the following experimental sequence: 1) a washout diet, 2) HF-LC or LC-HF diet, 3) a washout diet, 4) HF-LC or LC-HF diet. The experimental diet will be randomly assigned. Participants will be asked to provide a fasted blood sample and to collect fecal, urine and saliva samples at each visits.
详细描述
This study is a two arm dietary intervention study. Participants will be recruited from the WE-MACNUTR study based on the defined inclusion and exclusion criteria. The study duration will last up to 21 days.
Volunteers will be asked to participate in four 5-day periods while wearing glucose monitors (Abbott Freestyle Libre) with the following experimental sequence: 1) a washout diet, 2) HF-LC or LC-HF diet, 3) a washout diet, 4) HF-LC or LC-HF diet. The experimental diet will be randomly assigned.
Participants will enter the study on a usual (washout) diet and will have a 5-day run in period for baseline data collection. Participants will be asked to follow dietary guidance and consumed a healthy and balanced diet during this period.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants have completed WE-MACNUTR trial in 2019
- •Participants have no traveling plans within 1 months
- •Participants are able and willing to comply with the study protocol and provide informed consent
排除标准
- •Refuse or are unable to provide informed consent to participate in the study
- •Have long-term gastrointestinal diseases and take daily relevant medications
- •Have taken antibiotics in the last 2 weeks
- •Have type 2 diabetes and are taking medications or other treatments
- •Have chronic or acute liver disease and are taking medications or other treatments
- •Have cardiovascular diseases and are taking medications or other treatments
- •Have kidney disease and are taking medications
- •Suffer from chronic anxiety or depression, or other critical neuronal disorder and/or history of relevant medication
- •Are pregnant or lactating, or are planning to be pregnant in the next 3 months
- •Diagnosed with an eating disorder (e.g. anorexia nervosa or bulimia nervosa)
- •Are vegan, or unwilling to consume foods provided in the study
- •Have history of alcohol or drug addiction, or smoke above 15 cigarettes per day
结局指标
主要结局
Blood glucose profiling
时间窗: 20 days
Real-time blood glucose fluctuations will be recorded by CGM.
次要结局
未报告次要终点