Clinical trial NCT03058016: Personalized Nutrition Prediction for Metabolic Syndrome Patients, an Open Single-center Study
Official title: Personalized Nutrition Prediction for Metabolic Syndrome Patients, an Open Single-center Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Galilee CBR
Sponsor class: INDUSTRY
First posted: 2017-02-20
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: To determine number of participants with reduced BMI
timeFrame: One year
measure: To determine number of participants with reduced hA1C
timeFrame: One year
measure: To determine number of participants with reduced cholesterol
timeFrame: One year
Secondary outcomes:
measure: Type of intestinal microorganisms
timeFrame: One year
measure: Number of intestinal microorganisms
timeFrame: One year
Other outcomes:
Locations:
Study officials:
affiliation: 972545413328
name: Naomi Keren
role: STUDY_DIRECTOR
References: