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

Not Applicable

• Conditions: Metabolic Syndrome
• Interventions: Other: Personalized recommendations for diet

• Registration Number: NCT03058016
• Lead Sponsor: Galilee CBR

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.

Study Timeline

• Status Verified: 2017-02
• Study First Submitted: 2017-02-07
• Study First Submitted QC: 2017-02-15
• Last Update Submitted: 2017-02-15
• Study First Posted: 2017-02-20
• Last Update Posted: 2017-02-20
• Study Start: 2017-04-01
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Adults age 18-65
2. HBA1C between 5.5 and 7%.
3. Altered lipid metabolism
4. BMI > 25
5. Signed Informed Consent

Exclusion Criteria

1. Pregnancy
2. Usage of antibiotics within three months prior to participation
3. Chronically active inflammatory or neoplastic disease in the three years prior to enrollment
4. Chronic gastrointestinal disorder, including Inflammatory Bowel Disease and Celiac Disease
5. Skin disease, including contact dermatitis, precluding proper attachment of the continuous glucose monitor
6. Active psychiatric disorder
7. Myocardial infarction or cerebrovascular accident in the 6 months prior to participation
8. Chronic immunosuppressive medication usage
9. Clinical depression

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Personalized recommendations for diet	Personalized recommendations for diet	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.

Primary Outcome Measures

Name	Time	Method
To determine number of participants with reduced BMI	One year	Change at 12 months
To determine number of participants with reduced hA1C	One year	Change at 12 months
To determine number of participants with reduced cholesterol	One year	Change at 12 months

Secondary Outcome Measures

Name	Time	Method
Type of intestinal microorganisms	One year	The participants microbiome will be analyzed before and after the trial. The type of microorganisms will be determined by microbiological measurements.
Number of intestinal microorganisms	One year	The participants microbiome will be analyzed before and after the trial. The number of microorganisms will be determined by microbiological measurements.