Personalizing Mediterranean Diet in Children.

NCT03627923 | Active Not Recruiting

• 1 other identifier: 0694-17-RMC
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Personalized Nutrition In Children; Glucose, High Blood; Diet Habit

Keywords

Postprandial glucose response; Mediterranean diet; Personalized nutrition

Outcome Measures

Primary Outcomes (1)

• Postprandial glycemic response

  Continuous glucose monitor

  1-3 years

Secondary Outcomes (1)

• Microbiome composition and function

  1-3 years

Other Outcomes (1)

• Blood lipid profile

  1-3 years

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Healthy children will be invited to volunteer for the study.

You may qualify if:

• Healthy children
• years of age
• Tanner 1

You may not qualify if:

• Acute disease 2 months prior to enrollment
• Chronic illness in the past 5 years, including inflammatory, metabolic, neoplastic, congenital and infectious disease.
• 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

Sponsors & Collaborators

• Weizmann Institute of Science: lead
• Schneider Children's Medical Center, Israel: collaborator
• University of Naples: collaborator

Study Sites (1)

Weizmann Institute of Science

Rehovot, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, stool and urine samples

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Officials

• Eran Elinav, Prof

  Weizmann Institute of Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Eran Elinav

Study Record Dates

• First Submitted: July 4, 2018
• First Posted: August 14, 2018
• Study Start: December 27, 2018
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

IL (1)