Personalizing Mediterranean Diet in Children.

Status Recruiting

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Diet Habit
Glucose, High Blood
Personalized Nutrition In Children

Clinical Trial Details

NCT number	NCT03627923
Study type	Observational
Source	Weizmann Institute of Science
Contact	Aurelie Bukimer Mimran
Phone	+97289529089
Email	aurelie.bukimer@weizmann.ac.il
Status	Recruiting
Phase
Start date	December 27, 2018
Completion date	August 1, 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.