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临床试验/NCT03848299
NCT03848299已完成不适用

Personalized Nutrition & Citizen Science: A Healthy Diet Through Algorithms

Ecole Polytechnique Fédérale de Lausanne2 个研究点 分布在 1 个国家目标入组 1,782 人开始时间: 2019年1月15日最近更新:
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试验速览

阶段
不适用
状态
已完成
入组人数
1,782
试验地点
2
主要终点
Blood glucose level

研究概览

简要总结

Food & You is a large-scale citizen science research project in Switzerland. With this project, the researchers want to confirm that individuals respond differently to food, that is, that the blood sugar response (the level of sugar in the blood after a meal) varies among individuals, even after consumption of the same food or beverage. Secondly, the researchers want to develop an algorithm that will predict the individual blood sugar response and provide personalized diet recommendations.

详细描述

Food & You is one of the first large-scale citizen science research project in Switzerland. This project is building on the results of Zeevi et al. study, which demonstrated in 2015 for the first time with a cohort of 800 participants that there is a high interpersonal variability in postprandial (postmeal) glycemic responses (PPGR). In a second stage, the group developed an algorithm that predicts PPGR and gives personalized diet recommendation to better control the blood sugar level. These results have only been shown once, if they turn out to be correct, it will have a very strong impact on the field of nutrition. Other studies have since then also shown the variability in glucose response, leading to the concept of individual "glucotypes". The most important particularity of Food & You is that it will be a citizen science project. Citizen science is a method that involves volunteers in scientific research activities. It increases scientific knowledge, raises people's awareness of scientific questions, and allows scientists to share enthusiasm and expertise. Furthermore, to enable any citizen to take part, the study will be entirely coordinated digitally. It means that unlike conventional studies, no face-to-face interviews or medical appointments will be organized. All instructions will be given by a website and emails / text messages sent to the participants. The study material will be sent by post and the data will be collected via the website and the MyFoodRepo app. The participants will have to track during 14 days:

  • Their dietary intake with the myFoodRepo app.
  • Their physical activity and sleep with a smartphone app or an activity tracker.
  • Their glucose level wearing the FreeStyle Libre Sensor.
  • Collect a stool sample. The microbiome composition will be analyzed by sequencing the 16s rDNA extracted from the stool sample.
  • Answer anthropometric, demographic, and health online questionnaires.

With the Food & You project, the research team will build a new algorithm that will predict PPGR with input that is readily available through such a "digital cohort" (i.e. low-burden on user, and affordable) in order to test whether this can scale to tens or hundreds of thousands of people. The results of this project may have substantial consequences in dietary guidelines, personalized diet and on health conditions related to dietary intake.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Men and women aged 18+.
  • Have a postal address in Switzerland.
  • Own a smartphone, minimum version iOS 10/Android
  • Sufficient knowledge of French, German or English to read and understand the instructions.
  • Able to provide an informed consent.

排除标准

  • Pregnancy.
  • Persons on dialysis.
  • Persons with chronic immunosuppressive medication usage.
  • persons with skin disease, including contact dermatitis
  • Critically-ill patients.
  • Breastfeeding.
  • Usage of antibiotics in the three months prior to enrollment.
  • Chronically active inflammatory or neoplastic disease in the three years prior to enrollment.
  • Chronic gastrointestinal disorder, including Inflammatory Bowel Disease and Celiac disease.
  • Active neuropsychiatric disorder.
  • Myocardial infarction or cerebrovascular accident in the six months prior to enrollment.
  • Pre-diagnosed type I or type II diabetes mellitus.

结局指标

主要结局

Blood glucose level

时间窗: Two weeks

The participants will use the Flash Glucose Monitor FreeStyle Libre sensor and the FreeStyle Libre smartphone app from Abbott Diabetes Care to measure continuously during 14 days their glucose level.

次要结局

  • Optional: the quality of digestion related to the premenstrual syndrome (PMS)(Four weeks)
  • Physical activity intensity(Two weeks)
  • The sleep duration(Two weeks)
  • Optional: menstrual cycle ovulation day(Four weeks)
  • Physical activity frequency(Two weeks)
  • Physical activity duration(Two weeks)
  • The sleep timing(Two weeks)
  • Dietary intake(Two weeks)
  • Microbiome composition(Once during the two weeks)
  • Optional: the pain related to the premenstrual syndrome (PMS)(Four weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcel Salathé

Associate Professor

Ecole Polytechnique Fédérale de Lausanne

研究点 (2)

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