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

NCT03058016 | Unknown

• 1 other identifier: 98-16
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (3)

• To determine number of participants with reduced BMI

  Change at 12 months

  One year

• To determine number of participants with reduced hA1C

  Change at 12 months

  One year

• To determine number of participants with reduced cholesterol

  Change at 12 months

  One year

Secondary Outcomes (2)

• Type of intestinal microorganisms

  One year

• Number of intestinal microorganisms

  One year

Study Arms (1)

Personalized recommendations for diet

EXPERIMENTAL

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.

Other: Personalized recommendations for diet

Interventions

Personalized recommendations for diet OTHER

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

Personalized recommendations for diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults age 18-65
• HBA1C between 5.5 and 7%.
• Altered lipid metabolism
• BMI \> 25
• Signed Informed Consent

You may not qualify if:

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

Sponsors & Collaborators

• Galilee CBR: lead

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Diet

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Naomi Keren

  972545413328

  STUDY DIRECTOR

Central Study Contacts

Nadya Lisovoder, MD

CONTACT

+972524753435; nadyal@galilee-cbr.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: February 7, 2017
• First Posted: February 20, 2017
• Study Start: April 1, 2017
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: February 20, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share