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

Galilee Clinical Bio Research

Status: Unknown

Conditions: Metabolic Syndrome

Treatments: Other: Personalized recommendations for diet

Study type: Interventional

Funder types: Industry

Identifiers

NCT03058016

98-16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

Personalized recommendations for diet

Experimental group

Description:

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.

Treatment:

Other: Personalized recommendations for diet