Food HabitsFoodAndYouNCT03848299
Food & You: A Healthy Diet Through Algorithms
A study testing Experimental: Single Arm in people with Food Habits, run by Ecole Polytechnique Fédérale de Lausanne at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Habits
- What is being tested?
- Experimental: Single Arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,782 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Jan 2019to 18 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnancy.
- Persons on dialysis.
- Persons with chronic immunosuppressive medication usage.
- persons with skin disease, including contact dermatitis
- Critically-ill patients.
- Breastfeeding.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Food Habits
- Being tested
- Experimental: Single Arm
- Keywords
- Glycemic responses, Microbiota, Personalized nutrition, Digital cohort, Citizen Science
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Single ArmOther
Also called Standardized breakfasts consumption
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Single Arm | Experimental | 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. Receives: Other: Experimental: Single Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two weeks
Secondary outcomes (10)
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).
Measured: Two weeks
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.
Measured: Two weeks
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.
Measured: Two weeks
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.
Measured: Two weeks
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.
Measured: Two weeks
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.
Measured: Two weeks
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.
Measured: Once during the two weeks
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.
Measured: Four weeks
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.
Measured: Four weeks
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.
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start15 Jan 2019
- Primary completion9 Aug 2023
- Study completion18 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food HabitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The objective is to investigate the post-meal glucose response variations between individuals in function of their individual factors such as their microbiome composition or their lifestyle. All participants of the main cohort will have to follow a standardized diet during the first meal of the day from the second to the seventh day of the study participation. All participants will follow the same diet, 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.
- Masking
- None (open label)
- Enrolment
- 1,782 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ecole Polytechnique Fédérale de Lausanne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcel Salathé, Ecole Polytechnique Fédérale de Lausanne
- Investigators
- Marcel Salathé, Pr, Principal investigator, Ecole Polytechnique Fédérale de Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848299
- Sponsor's protocol ID
- 2017-02124
- Other IDs
- 2017
- Acronym
- FoodAndYou
- Status last verified
- Mar 2024
- First submitted
- 12 Feb 2019
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Singh R, McDonald D, Hernandez AR, Song SJ, Bartko A, Knight R, Salathe M. Temporal nutrition analysis associates dietary regularity and quality with gut microbiome diversity: insights from the Food & You digital cohort. Nat Commun. 2025 Sep 30;16(1):8635. doi: 10.1038/s41467-025-63799-z.
PubMed 41028733
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Nutrition & Citizen Science: A Healthy Diet Through Algorithms
- ClinicalTrials.gov ID
- NCT03848299
- Acronym / sponsor ID
- FoodAndYou / 2017-02124
- Conditions
- Food Habits
- Keywords
- Glycemic responses, Microbiota, Personalized nutrition, Digital cohort, Citizen Science
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,782 participants (actual)
- Lead sponsor
- Ecole Polytechnique Fédérale de LausanneUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 9 Aug 2023 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 20 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The objective is to investigate the post-meal glucose response variations between individuals in function of their individual factors such as their microbiome composition or their lifestyle. All participants of the main cohort will have to follow a standardized diet during the first meal of the day from the second to the seventh day of the study participation. All participants will follow the same diet, 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Single Arm | Experimental | Other: Experimental: Single ArmAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- Pregnancy.
- Persons on dialysis.
- Persons with chronic immunosuppressive medication usage.
- persons with skin disease, including contact dermatitis
- Critically-ill patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Single ArmAlso: Standardized breakfasts consumptionAll 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 | Experimental: Single Arm |
Primary outcome
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.
10 secondary outcomes
Dietary intake
Time frame: Two weeks
Physical activity intensity
Time frame: Two weeks
Physical activity frequency
Time frame: Two weeks
Physical activity duration
Time frame: Two weeks
The sleep duration
Time frame: Two weeks
The sleep timing
Time frame: Two weeks
Microbiome composition
Time frame: Once during the two weeks
Optional: menstrual cycle ovulation day
Time frame: Four weeks
Optional: the pain related to the premenstrual syndrome (PMS)
Time frame: Four weeks
Optional: the quality of digestion related to the premenstrual syndrome (PMS)
Time frame: Four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Derived from this study: PubMed 41028733Singh R, McDonald D, Hernandez AR, Song SJ, Bartko A, Knight R, Salathe M. Temporal nutrition analysis associates dietary regularity and quality with gut microbiome diversity: insights from the Food & You digital cohort. Nat Commun. 2025 Sep 30;16(1):8635. doi: 10.1038/s41467-025-63799-z.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcel Salathé, Pr principal investigator
Ecole Polytechnique Fédérale de Lausanne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Single Arm in people with Food Habits, run by Ecole Polytechnique Fédérale de Lausanne at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose level (time frame: Two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03848299, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.