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

Primary Purpose

Metabolic Syndrome

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Personalized recommendations for diet

About this trial

This is an interventional prevention trial for Metabolic Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Personalized recommendations for diet

Arm 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.

Outcomes

Primary Outcome Measures

To determine number of participants with reduced BMI

Change at 12 months

To determine number of participants with reduced hA1C

Change at 12 months

To determine number of participants with reduced cholesterol

Change at 12 months

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT03058016

First Posted

February 7, 2017

Last Updated

February 15, 2017

Sponsor

Galilee CBR

1. Study Identification

Unique Protocol Identification Number

NCT03058016

Brief Title

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

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2017 (Anticipated)

Primary Completion Date

April 1, 2022 (Anticipated)

Study Completion Date

April 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Galilee CBR

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Personalized recommendations for diet

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Personalized recommendations for diet

Intervention Description

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

Primary Outcome Measure Information:

Title

To determine number of participants with reduced BMI

Description

Change at 12 months

Time Frame

One year

Title

To determine number of participants with reduced hA1C

Description

Change at 12 months

Time Frame

One year

Title

To determine number of participants with reduced cholesterol

Description

Change at 12 months

Time Frame

One year

Secondary Outcome Measure Information:

Title

Type of intestinal microorganisms

Description

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

Title

Number of intestinal microorganisms

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adults age 18-65 HBA1C between 5.5 and 7%. Altered lipid metabolism BMI > 25 Signed Informed Consent Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nadya Lisovoder, MD

Phone

+972524753435

nadyal@galilee-cbr.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Naomi Keren

Organizational Affiliation

972545413328

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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