Personalizing Mediterranean Diet in Children.

NCT ID: NCT03627923

Last Updated: 2024-12-27

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-27
• Study Completion Date: 2025-12-01

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.

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.

Conditions

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

Keywords

Postprandial glucose response; Mediterranean diet; Personalized nutrition

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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.
• 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Schneider Children's Medical Center, Israel

OTHER

Sponsor Role: collaborator

University of Naples

OTHER

Sponsor Role: collaborator

Weizmann Institute of Science

OTHER

Sponsor Role: lead

Responsible Party

Eran Elinav

Prof. Eran Elinav

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eran Elinav, Prof

Role: PRINCIPAL_INVESTIGATOR

Weizmann Institute of Science

Locations

Weizmann Institute of Science

Rehovot, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Aurelie Bukimer Mimran

Role: CONTACT

Phone: +97289529089

Email: aurelie.bukimer@weizmann.ac.il

Shimrit Eliyahu miller

Role: CONTACT

Phone: +97289529089

Email: shimrit.miller@weizmann.ac.il

Facility Contacts

aurelie Bukimer mimran

Role: primary

Shimrit Eliyahu miller

Role: backup

Other Identifiers

0694-17-RMC

Identifier Type: -

Identifier Source: org_study_id