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Trial record 20 of 95 for:    body | Recruiting, Not yet recruiting, Available Studies | "Metabolic Syndrome X"

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

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ClinicalTrials.gov Identifier: NCT03058016
Recruitment Status : Not yet recruiting
First Posted : February 20, 2017
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):
Galilee CBR

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.


Condition or disease Intervention/treatment Phase
Metabolic Syndrome Other: Personalized recommendations for diet Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Personalized Nutrition Prediction for Metabolic Syndrome Patients, an Open Single-center Study
Estimated Study Start Date : April 1, 2017
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Personalized recommendations for diet

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




Primary Outcome Measures :
  1. To determine number of participants with reduced BMI [ Time Frame: One year ]
    Change at 12 months

  2. To determine number of participants with reduced hA1C [ Time Frame: One year ]
    Change at 12 months

  3. To determine number of participants with reduced cholesterol [ Time Frame: One year ]
    Change at 12 months


Secondary Outcome Measures :
  1. Type of intestinal microorganisms [ Time Frame: One year ]
    The participants microbiome will be analyzed before and after the trial. The type of microorganisms will be determined by microbiological measurements.

  2. Number of intestinal microorganisms [ Time Frame: One year ]
    The participants microbiome will be analyzed before and after the trial. The number of microorganisms will be determined by microbiological measurements.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03058016


Contacts
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Contact: Nadya Lisovoder, MD +972524753435 nadyal@galilee-cbr.com

Sponsors and Collaborators
Galilee CBR
Investigators
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Study Director: Naomi Keren 972545413328

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Responsible Party: Galilee CBR
ClinicalTrials.gov Identifier: NCT03058016     History of Changes
Other Study ID Numbers: 98-16
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Syndrome
Metabolic Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases