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Personalizing Mediterranean Diet in Children.

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ClinicalTrials.gov Identifier: NCT03627923
Recruitment Status : Recruiting
First Posted : August 14, 2018
Last Update Posted : December 17, 2021
Sponsor:
Collaborators:
Schneider Children's Medical Center, Israel
University of Naples
Information provided by (Responsible Party):
Eran Elinav, Weizmann Institute of Science

Study Description
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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.


Condition or disease
Personalized Nutrition In Children Glucose, High Blood Diet Habit

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
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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Personalizing Mediterranean Diet in Children: the Ferrero Pilot Trial.
Actual Study Start Date : December 27, 2018
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 1, 2022
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Postprandial glycemic response [ Time Frame: 1-3 years ]
    Continuous glucose monitor


Secondary Outcome Measures :
  1. Microbiome composition and function [ Time Frame: 1-3 years ]
    Stool and urine samples


Other Outcome Measures:
  1. Blood lipid profile [ Time Frame: 1-3 years ]
    Blood tests


Biospecimen Retention:   Samples Without DNA
Blood, stool and urine samples

Eligibility Criteria
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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy children will be invited to volunteer for the study.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627923


Contacts
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Contact: Aurelie Bukimer Mimran +97289529089 aurelie.bukimer@weizmann.ac.il
Contact: Shimrit Eliyahu miller +97289529089 shimrit.miller@weizmann.ac.il

Locations
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Israel
Weizmann Institute of Science Recruiting
Reẖovot, Israel
Contact: aurelie Bukimer mimran    +97289529089    aurelie.bukimer@weizmann.ac.il   
Contact: Shimrit Eliyahu miller    ++97289529089    shimrit.miller@weizmann.ac.il   
Sponsors and Collaborators
Weizmann Institute of Science
Schneider Children's Medical Center, Israel
University of Naples
Investigators
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Principal Investigator: Eran Elinav, Prof Weizmann Institute of Science
More Information
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Responsible Party: Eran Elinav, Prof. Eran Elinav, Weizmann Institute of Science
ClinicalTrials.gov Identifier: NCT03627923    
Other Study ID Numbers: 0694-17-RMC
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: December 17, 2021
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eran Elinav, Weizmann Institute of Science:
Postprandial glucose response
Mediterranean diet
Personalized nutrition
Additional relevant MeSH terms:
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Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases