NCT03848299

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,782

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2019

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 20, 2019

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2023

Completed
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

4.6 years

First QC Date

February 12, 2019

Last Update Submit

March 22, 2024

Conditions

Keywords

Glycemic responsesMicrobiotaPersonalized nutritionDigital cohortCitizen Science

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Dietary intake

    Two weeks

  • Physical activity intensity

    Two weeks

  • Physical activity frequency

    Two weeks

  • Physical activity duration

    Two weeks

  • The sleep duration

    Two weeks

  • +5 more secondary outcomes

Study Arms (1)

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.

Other: Experimental: Single Arm

Interventions

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.

Also known as: Standardized breakfasts consumption
Experimental: Single Arm

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Details50% men, 50% women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Epfl Sv Ghi Upsalathe1

Geneva, 1202, Switzerland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Marcel Salathé, Pr

    Ecole Polytechnique Fédérale de Lausanne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 12, 2019

First Posted

February 20, 2019

Study Start

January 15, 2019

Primary Completion

August 9, 2023

Study Completion

December 18, 2023

Last Updated

March 26, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations