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

G

Galilee Clinical Bio Research

Status

Unknown

Conditions

Metabolic Syndrome

Treatments

Other: Personalized recommendations for diet

Study type

Interventional

Funder types

Industry

Identifiers

NCT03058016
98-16

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

500 participants in 1 patient group

Personalized recommendations for diet
Experimental group
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.
Treatment:
Other: Personalized recommendations for diet

Trial contacts and locations

0

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Central trial contact

Nadya Lisovoder, MD

Data sourced from clinicaltrials.gov

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