Personalized Nutrition Prediction for Metabolic Syndrome Patients, an Open Single-center Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Metabolic Syndrome
- Sponsor
- Galilee CBR
- Enrollment
- 500
- Primary Endpoint
- To determine number of participants with reduced BMI
- Last Updated
- 9 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults age 18-65
- •HBA1C between 5.5 and 7%.
- •Altered lipid metabolism
- •Signed Informed Consent
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
To determine number of participants with reduced BMI
Time Frame: One year
Change at 12 months
To determine number of participants with reduced hA1C
Time Frame: One year
Change at 12 months
To determine number of participants with reduced cholesterol
Time Frame: One year
Change at 12 months
Secondary Outcomes
- Type of intestinal microorganisms(One year)
- Number of intestinal microorganisms(One year)