Food & You: A Healthy Diet Through Algorithms

Food Habits Clinical Trial

— FoodAndYou  

Official title:

Personalized Nutrition & Citizen Science: A Healthy Diet Through Algorithms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03848299
• Other study ID #: 2017-02124
• Status: Completed
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: December 18, 2023

Study information

• Verified date: March 2024
• Source: Ecole Polytechnique Fédérale de Lausanne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1782
• Est. completion date: December 18, 2023
• Est. primary completion date: August 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Food Habits

Intervention

Other:
• Experimental: Single Arm
All participants will have to consume the same standardized breakfasts from the second to the seventh day, except the ones that are intolerant or allergic to lactose or/and gluten. In those cases, they will follow an adapted diet for their intolerance or allergies. Day 2 and 3: 110 g white bread. Day 4 and 5 : 110 g white bread and 30 g butter or 55 g white bread, 50 g dark chocolate for lactose intolerant. Day 6 and 7: Glucose drink (50g). The bread will be replaced by gluten-free bread for gluten intolerant participants.

Locations

Country	Name	City	State
Switzerland	Epfl Sv Ghi Upsalathe1	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Ecole Polytechnique Fédérale de Lausanne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose level	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.	Two weeks
Secondary	Dietary intake	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).	Two weeks
Secondary	Physical activity intensity	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.	Two weeks
Secondary	Physical activity frequency	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.	Two weeks
Secondary	Physical activity duration	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.	Two weeks
Secondary	The sleep duration	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.	Two weeks
Secondary	The sleep timing	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.	Two weeks
Secondary	Microbiome composition	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.	Once during the two weeks
Secondary	Optional: menstrual cycle ovulation day	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.	Four weeks
Secondary	Optional: the pain related to the premenstrual syndrome (PMS)	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.	Four weeks
Secondary	Optional: the quality of digestion related to the premenstrual syndrome (PMS)	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.	Four weeks