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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03058016
• Other study ID #: 98-16
• Status: Not yet recruiting
• Phase: N/A
• First received: February 7, 2017
• Last updated: February 15, 2017
• Start date: April 1, 2017
• Est. completion date: April 1, 2022

Study information

• Verified date: February 2017
• Source: Galilee CBR
• Contact: Nadya Lisovoder, MD
• Phone: +972524753435
• Email: nadyal[@]galilee-cbr.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Galilee CBR

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine number of participants with reduced BMI	Change at 12 months	One year
Primary	To determine number of participants with reduced hA1C	Change at 12 months	One year
Primary	To determine number of participants with reduced cholesterol	Change at 12 months	One year
Secondary	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.	One year
Secondary	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.	One year