- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03848299
Food & You: A Healthy Diet Through Algorithms (FoodAndYou)
Personalized Nutrition & Citizen Science: A Healthy Diet Through Algorithms
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marcel Salathé, Pr
- Phone Number: +41 216930991
- Email: marcel.salathe@epfl.ch
Study Contact Backup
- Name: Chloé Allémann
- Phone Number: +41 216955037
- Email: chloe.allemann@epfl.ch
Study Locations
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Geneva, Switzerland, 1202
- Epfl Sv Ghi Upsalathe1
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood glucose level
Time Frame: Two weeks
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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.
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Two weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dietary intake
Time Frame: Two weeks
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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).
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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.
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Two weeks
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Physical activity frequency
Time Frame: Two weeks
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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.
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Two weeks
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Physical activity duration
Time Frame: Two weeks
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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.
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Two weeks
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The sleep duration
Time Frame: Two weeks
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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.
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Two weeks
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The sleep timing
Time Frame: Two weeks
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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.
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Two weeks
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Microbiome composition
Time Frame: Once during the two weeks
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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.
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Once during the two weeks
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Optional: menstrual cycle ovulation day
Time Frame: Four weeks
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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.
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Four weeks
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Optional: the pain related to the premenstrual syndrome (PMS)
Time Frame: Four weeks
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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.
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Four weeks
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Optional: the quality of digestion related to the premenstrual syndrome (PMS)
Time Frame: Four weeks
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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.
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Four weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Marcel Salathé, Pr, Ecole Polytechnique Fédérale de Lausanne
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2017-02124
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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