Personalized Nutrition In ChildrenNCT03627923
Personalizing Mediterranean Diet in Children.
An observational study of Personalized Nutrition In Children and Glucose, High Blood, run by Weizmann Institute of Science at 1 site in Israel.
Trial summary
Investigating glucose response to Mediterranean and regular diets in healthy children in order to develop specific pediatric machine-learning for predicting the personalized glucose response to food for individual children. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Personalized Nutrition In Children, Glucose, High Blood, Diet Habit
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 27 Dec 2018to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy children will be invited to volunteer for the study.
Who may be able to join
- Healthy children
- 6-11 years of age
- Tanner 1
- Exclusion criteria:
- Acute disease 2 months prior to enrollment
- Chronic illness in the past 5 years, including inflammatory, metabolic, neoplastic, congenital and infectious disease.
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- Use of medications (e.g. Antibiotics/antifungal, PPI, analgesics) and any antibiotics 3 months prior to the first visit, PPI one month prior to the beginning of the study or use of medication during the study.
- Treatment with anti-diabetic medications;
- Neuro-psychiatric disorders
- Cancer and recent anticancer treatment
- Eating disorders (Anorexia nervosa. Bulimia nervosa. Binge eating disorder, Night eating syndrome).
- Inability of the participant and/or nuclear family to follow and utilize the smartphone application.
- Dietary restrictions or specific dietary regimen
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personalizing Mediterranean Diet in Children: the Ferrero Pilot Trial.
Investigating glucose response to Mediterranean and regular diets in healthy children in order to develop specific pediatric machine-learning for predicting the personalized glucose response to food for individual children.
The prediction will be based on multiple measurements, including blood tests, personal lifestyle and gut microbiome. This will allow investigators to design personalized Mediterranean machine-learning-based diets which may potentially reduce the burden of disease in adulthood as well as the burden of obesity in the pediatric age.
Read the detailed description
Early-life nutrition plays a critical role in mid-term and long-term metabolic and nutritional outcomes. However, the mechanisms underlying the effects of early nutrition on health are yet to be fully understood. Recently, it has been shown that alterations in intestinal microbiota and modulation of the immune response induced by food serve as the main mechanisms involved in the development of inflammatory conditions such as asthma, inflammatory bowel diseases, and cardiovascular disease. The Mediterranean diet has been shown to reduce the risk of cardiovascular disease, cancer, depression, colorectal cancer, diabetes, obesity, asthma, cognitive decline and premature death in general. Some studies also reported a positive effect of Mediterranean diet on glycemic control. However, whether this diet is a benefit to all individuals is unknown. Likewise, whether gut microbiome and its responses to diet is involved in these effects, or whether different Mediterranean diets may be optimized at the individualized level remains unstudied.
Recently, the investigators developed an algorithm enabling to predict the personalized postprandial glucose responses to food in adult healthy individuals. However, personalized nutrition was never tested on children.
In this study, children will be followed up in different bio-geographical locations. The primary aim of the study is to develop specific pediatric algorithms for predicting the personalized glucose response to food for individual children. This prediction will be based on multiple measurements, including blood and urine tests, anthropometric measurements, personal lifestyle and gut microbiome. This may allow the investigators to design personalized Mediterranean algorithm-based diets which may potentially reduce the burden of non-communicable disease in adulthood as well as the burden of obesity in the pediatric age.
- Keywords
- Postprandial glucose response, Mediterranean diet, Personalized nutrition
- Medical subject headings
- Feeding Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glycemic response
Continuous glucose monitor
Measured: 1-3 years
Secondary outcomes (1)
Microbiome composition and function
Stool and urine samples
Measured: 1-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start27 Dec 2018
- Primary completionDec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Personalized Nutrition In ChildrenStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weizmann Institute of Science
- Sponsor type
- University, hospital or other
- Collaborators
- Schneider Children's Medical Center, Israel, University of Naples
- Responsible party
- Principal investigator, Eran Elinav, Weizmann Institute of Science
- Investigators
- Eran Elinav, Prof, Principal investigator, Weizmann Institute of Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03627923
- Sponsor's protocol ID
- 0694-17-RMC
- Status last verified
- Mar 2026
- First submitted
- 4 Jul 2018
- Last updated
- 19 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalizing Mediterranean Diet in Children: the Ferrero Pilot Trial.
- ClinicalTrials.gov ID
- NCT03627923
- Acronym / sponsor ID
- 0694-17-RMC
- Keywords
- Postprandial glucose response, Mediterranean diet, Personalized nutrition
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Weizmann Institute of ScienceUniversity, hospital or other
- Collaborators
- Schneider Children's Medical Center, Israel, University of Naples
- Study start
- 27 Dec 2018 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 14 Aug 2018 (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.
Investigating glucose response to Mediterranean and regular diets in healthy children in order to develop specific pediatric machine-learning for predicting the personalized glucose response to food for individual children.
The prediction will be based on multiple measurements, including blood tests, personal lifestyle and gut microbiome. This will allow investigators to design personalized Mediterranean machine-learning-based diets which may potentially reduce the burden of disease in adulthood as well as the burden of obesity in the pediatric age.
Detailed description
Early-life nutrition plays a critical role in mid-term and long-term metabolic and nutritional outcomes. However, the mechanisms underlying the effects of early nutrition on health are yet to be fully understood. Recently, it has been shown that alterations in intestinal microbiota and modulation of the immune response induced by food serve as the main mechanisms involved in the development of inflammatory conditions such as asthma, inflammatory bowel diseases, and cardiovascular disease. The Mediterranean diet has been shown to reduce the risk of cardiovascular disease, cancer, depression, colorectal cancer, diabetes, obesity, asthma, cognitive decline and premature death in general. Some studies also reported a positive effect of Mediterranean diet on glycemic control. However, whether this diet is a benefit to all individuals is unknown. Likewise, whether gut microbiome and its responses to diet is involved in these effects, or whether different Mediterranean diets may be optimized at the individualized level remains unstudied.
Recently, the investigators developed an algorithm enabling to predict the personalized postprandial glucose responses to food in adult healthy individuals. However, personalized nutrition was never tested on children.
In this study, children will be followed up in different bio-geographical locations. The primary aim of the study is to develop specific pediatric algorithms for predicting the personalized glucose response to food for individual children. This prediction will be based on multiple measurements, including blood and urine tests, anthropometric measurements, personal lifestyle and gut microbiome. This may allow the investigators to design personalized Mediterranean algorithm-based diets which may potentially reduce the burden of non-communicable disease in adulthood as well as the burden of obesity in the pediatric age.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy children will be invited to volunteer for the study.
Key inclusion criteria (13 listed)
- Healthy children
- 6-11 years of age
- Tanner 1
- Acute disease 2 months prior to enrollment
- Chronic illness in the past 5 years, including inflammatory, metabolic, neoplastic, congenital and infectious disease.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postprandial glycemic response
Time frame: 1-3 years
Continuous glucose monitor
1 secondary outcome
Microbiome composition and function
Time frame: 1-3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
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.
Eran Elinav, Prof principal investigator
Weizmann Institute of Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Personalized Nutrition In Children and Glucose, High Blood, run by Weizmann Institute of Science at 1 site in Israel.
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 13 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. 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 Israel. 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?
This study is still under way. Results are not available in the source record yet.
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?
Postprandial glycemic response (time frame: 1-3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.