Personalized Nutrition Prediction for Metabolic Syndrome Patients, an Open Single-center Study

Study Overview
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Brief Summary
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This clinical study is designed to evaluate the providing of a computational prediction engine for optimization of personalized nutrition Personalized recommendations for effective diet, lifestyle and activities based on the patient's parameters measurements and reactions will be provided on a bi-weekly basis, all Lab tests and dietician control will be performed twice a month.

Detailed Description
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Pre-diabetic and pre-metabolic syndrome patients will be recruited to the study for a period of one year. After measurement of individual's parameters changes as blood tests, gut microbiome, urine tests, blood pressure, heart performance, body circumferences, mood and mental status as well as monitoring each individual's food intake - a model to predict individual's body reaction according to lifestyle, eating and activity habits will be built. Personalized recommendations for effective diet, lifestyle and activities based on the patient's parameters measurements and reactions will be provided on a bi-weekly basis, all Lab tests and dietician control will be performed twice a month.

Official Title
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Personalized Nutrition Prediction for Metabolic Syndrome Patients, an Open Single-center Study

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Other: Personalized recommendations for diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults age 18-65 HBA1C between 5.5 and 7%. Altered lipid metabolism BMI > 25 Signed Informed Consent Exclusion Criteria: Pregnancy Usage of antibiotics within three months prior to participation Chronically active inflammatory or neoplastic disease in the three years prior to enrollment Chronic gastrointestinal disorder, including Inflammatory Bowel Disease and Celiac Disease Skin disease, including contact dermatitis, precluding proper attachment of the continuous glucose monitor Active psychiatric disorder Myocardial infarction or cerebrovascular accident in the 6 months prior to participation Chronic immunosuppressive medication usage Clinical depression

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Personalized recommendations for effective diet, lifestyle and activities based on the patient's parameters measurements and reactions will be provided on a bi-weekly basis, all Lab tests and dietician control will be performed twice a month.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personalized recommendations for diet<br>After measurement of individual's parameters changes as blood tests, gut microbiome, urine tests, blood pressure, heart performance, body circumferences, mood and mental status as well as monitoring each individual's food intake - a model to predict individual's body reaction according to lifestyle, eating and activity habits will be built. Personalized recommendations for effective diet, lifestyle and activities based on the patient's parameters measurements and reactions will be provided on a bi-weekly basis, all Lab tests and dietician control will be performed twice a month. | Other: Personalized recommendations for diet<br>* Personalized recommendations for effective diet, lifestyle and activities based on the patient's parameters measurements and reactions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine number of participants with reduced BMI | Change at 12 months | One year | 
| To determine number of participants with reduced hA1C | Change at 12 months | One year | 
| To determine number of participants with reduced cholesterol | Change at 12 months | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of intestinal microorganisms | The participants microbiome will be analyzed before and after the trial. The type of microorganisms will be determined by microbiological measurements. | One year | 
| Number of intestinal microorganisms | The participants microbiome will be analyzed before and after the trial. The number of microorganisms will be determined by microbiological measurements. | One year |