Food & You: A Healthy Diet Through Algorithms (FoodAndYou)

March 22, 2024 updated by: Marcel Salathé, Ecole Polytechnique Fédérale de Lausanne

Personalized Nutrition & Citizen Science: A Healthy Diet Through Algorithms

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1782

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Geneva, Switzerland, 1202
        • Epfl Sv Ghi Upsalathe1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.

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.

Other Names:
  • Standardized breakfasts consumption

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood glucose level
Time Frame: 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.
Two weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marcel Salathé, Pr, Ecole Polytechnique Fédérale de Lausanne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2019

Primary Completion (Actual)

August 9, 2023

Study Completion (Actual)

December 18, 2023

Study Registration Dates

First Submitted

February 12, 2019

First Submitted That Met QC Criteria

February 19, 2019

First Posted (Actual)

February 20, 2019

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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