Food & You: A Healthy Diet Through Algorithms
- Conditions
- Food Habits
- Registration Number
- NCT03848299
- Lead Sponsor
- Ecole Polytechnique Fédérale de Lausanne
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1782
- Men and women aged 18+.
- Have a postal address in Switzerland.
- Own a smartphone, minimum version iOS 10/Android 5.
- Sufficient knowledge of French, German or English to read and understand the instructions.
- Able to provide an informed consent.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Blood glucose level 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.
- Secondary Outcome Measures
Name Time Method Optional: the quality of digestion related to the premenstrual syndrome (PMS) Four weeks The quality of digestion will be assessed to detect PMS. The participants will have to log manually this features in the study website. This part is optional.
Physical activity intensity Two weeks The intensity of the physical activity. By default, the participants will have to log manually this features in the study website. In case a participant prefers to use an activity tracker or a smartphone app he/she owns instead of manual logging, it will also be possible.
The sleep duration Two weeks The duration of sleep will be assessed. By default, the participants will have to log manually this features in the study website. In case a participant prefers to use an activity tracker or a smartphone app he/she owns instead of manual logging, it will also be possible.
Optional: menstrual cycle ovulation day Four weeks The ovulation day will be detected by basal temperature measurements and optionally the cervical mucus quality observations. The participants will have to log manually this features in the study website. This part is optional.
Physical activity frequency Two weeks The frequency of the physical activity. By default, the participants will have to log manually this features in the study website. In case a participant prefers to use an activity tracker or a smartphone app he/she owns instead of manual logging, it will also be possible.
Physical activity duration Two weeks The duration of the physical activity. By default, the participants will have to log manually this features in the study website. In case a participant prefers to use an activity tracker or a smartphone app he/she owns instead of manual logging, it will also be possible.
The sleep timing Two weeks The timing of sleep will be assessed. By default, the participants will have to log manually this features in the study website. In case a participant prefers to use an activity tracker or a smartphone app he/she owns instead of manual logging, it will also be possible.
Dietary intake Two weeks Food consumption information will be collected through the smartphone app myFoodRepo. The participants will track their dietary intake by taking pictures of all consumed food and beverages (including water).
Microbiome composition Once during the two weeks The participants will collect a stool sample. We will transfer the samples to Microsynth, a company specialized in DNA sequencing. They will extract the DNA from the stool sample and sequence the ribosomal DNA (16S rDNA) with Next-Generation Sequencing (NGS) technology. The composition of microbial communities in the gut of each participant will be determined by bioinformatic analysis.
Optional: the pain related to the premenstrual syndrome (PMS) Four weeks The pain will be assessed to detect PMS. The participants will have to log manually this features in the study website. This part is optional.
Trial Locations
- Locations (1)
Epfl Sv Ghi Upsalathe1
🇨🇭Geneva, Switzerland