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

NCT ID: NCT03058016

Last Updated: 2017-02-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2022-04-01

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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Personalized recommendations for diet

Intervention Type: OTHER

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

Interventions

Personalized recommendations for diet

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galilee CBR

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Naomi Keren

Role: STUDY_DIRECTOR

972545413328

Central Contacts

Nadya Lisovoder, MD

Role: CONTACT

nadyal@galilee-cbr.com

+972524753435

Other Identifiers

98-16

Identifier Type: -

Identifier Source: org_study_id