Personalizing Mediterranean Diet in Children. (NCT03627923) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Personalizing Mediterranean Diet in Children.
Israel200 participantsStarted 2018-12-27
Plain-language 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.
Who can participate
Age range
6 Years – 11 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.