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

Galilee CBR500 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

500

Conditions

Metabolic Syndrome

Interventions

Personalized recommendations for dietOTHER

Personalized recommendations for effective diet, lifestyle and activities based on the patient's parameters measurements and reactions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

To determine number of participants with reduced BMI

Change at 12 months

Time frame: One year

To determine number of participants with reduced hA1C

Change at 12 months

Time frame: One year

To determine number of participants with reduced cholesterol

Change at 12 months

Time frame: One year

Secondary Outcomes

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.

Time frame: 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.

Time frame: One year

Central Contacts

Nadya Lisovoder, MD

CONTACT

+972524753435 nadyal@galilee-cbr.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.