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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03058016

Enrollment

500

Registered

2017-02-20

Start date

2017-04-01

Completion date

2022-04-01

Last updated

2017-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

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.

Interventions

OTHERPersonalized recommendations for diet

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
To determine number of participants with reduced BMI	One year	Change at 12 months
To determine number of participants with reduced hA1C	One year	Change at 12 months
To determine number of participants with reduced cholesterol	One year	Change at 12 months

Secondary

Measure	Time frame	Description
Type of intestinal microorganisms	One year	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	One year	The participants microbiome will be analyzed before and after the trial. The number of microorganisms will be determined by microbiological measurements.

Contacts

Primary ContactNadya Lisovoder, MD

nadyal@galilee-cbr.com+972524753435

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026