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临床试验/NCT05054153
NCT05054153已完成不适用

Westlake Precision Nutrition Study: Diet Challenges for Glucose Metabolism

Westlake University1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2021年10月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
176
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, which aims to explore different diet challenges for glucose metabolism, including carbohydrates and intermittent fasting (IF) dietary pattern. Considering the glucose responses to the same food are largely heterogeneous among people, this study integrates the concepts of precision nutrition and N-of-1 design. The study also aims to explore differences in brain structure and function between participants with different Body Mass Index (BMI) from the perspective of gut-brain axis.

详细描述

This study aims for precision nutrition. Participants will be required to wear continuous glucose monitoring (CGM) for 14 days. The diet intervention will be carried out after wearing CGM on Day 1. Individual N-of-1 trial design will be employed during Day 2 to Day 7 to compare the difference of postprandial glucose response to white bread or plain oats. These two breakfasts will appear in alternating order every successive 2 days, and these successive 2 days will be defined as one set. There will be 3 sets during Day 2 to Day 7. Between lunch and dinner will be the wash out period for the remaining effect of the last breakfast intervention on blood glucose homeostasis. In this period, participants will be allowed to choose foods without restrictions, but dietary records are required. The period during Day 8 to Day 14 is defined as intermittent fasting (IF) period, and participants will experience moderate fasting on Day 9 and Day 13 with total energy intake restrained within 500-600 kcal. In these two fasting days, participants will be provided with daily three meals. Investigators will closely monitor participants' latent adverse response and compliance to ensure the intervention will be completed with adequate safety and high compliancy. Oral glucose tolerance test (OGTT) will be conducted in the morning of Day 8 and Day 14 to test the changes of glucose tolerance before and after one set of IF intervention. Electroencephalogram (EEG) and functional Magnetic Resonance Imaging (fMRI) scanning will be conducted as per standard procedure at baseline.

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
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants reside in Hangzhou
  • Participants have no traveling plans within 3 months

排除标准

  • Refusing or unable to give informed consent
  • Participants with chronic gastrointestinal diseases and take daily relevant medications
  • Participants with metabolic diseases including diabetes, hypertension and cardiovascular diseases (CVD)
  • Participants with craniocerebral trauma, cancer, liver disease, kidney disease, or other critical illness, or history of operation or medication
  • Participants with bulimia nervosa, post-traumatic stress disorder (PTSD), chronic anxiety and depression or other critical neuronal disorder or history of relevant medication
  • Being or to be pregnant or lactating.
  • Participants with history of alcohol or drug addiction, or smoke above 15 cigarettes per day
  • Concurrently participating other clinical trials.

结局指标

主要结局

Blood glucose profiling

时间窗: 14 days

Real-time blood glucose fluctuations will be recorded by CGM.

Change of glucose tolerance before and after intermittent fasting

时间窗: Day 8 and Day 13

Oral glucose tolerance test will also be conducted.

次要结局

未报告次要终点

研究者

发起方
Westlake University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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Westlake Precision Nutrition Study | 临床试验