Metabolic SyndromeNCT03058016
Personalized Nutrition Prediction for Metabolic Syndrome Patients, an Open Single-center Study
A study testing Personalized recommendations for diet in people with Metabolic Syndrome, run by Galilee CBR.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Personalized recommendations for diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2017to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age 18-65
- HBA1C between 5.5 and 7%.
- Altered lipid metabolism
- BMI > 25
- Signed Informed Consent
Who cannot join
- 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
Show all 9Show fewer
- Myocardial infarction or cerebrovascular accident in the 6 months prior to participation
- Chronic immunosuppressive medication usage
- Clinical depression
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- Personalized recommendations for diet
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized recommendations for dietOther
Personalized recommendations for effective diet, lifestyle and activities based on the patient's parameters measurements and reactions
| Study group | Role | What they receive |
|---|---|---|
| Personalized recommendations for diet | Experimental | 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. Receives: Other: Personalized recommendations for diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine number of participants with reduced BMI
Change at 12 months
Measured: One year
To determine number of participants with reduced hA1C
Change at 12 months
Measured: One year
To determine number of participants with reduced cholesterol
Change at 12 months
Measured: One year
Secondary outcomes (2)
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.
Measured: One year
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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start1 Apr 2017 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Galilee CBR
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Naomi Keren, Study director, 972545413328
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058016
- Sponsor's protocol ID
- 98-16
- Status last verified
- Feb 2017
- First submitted
- 7 Feb 2017
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Nutrition Prediction for Metabolic Syndrome Patients, an Open Single-center Study
- ClinicalTrials.gov ID
- NCT03058016
- Acronym / sponsor ID
- 98-16
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Galilee CBRIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2017 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 20 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Personalized recommendations for diet | Experimental | Other: Personalized recommendations for dietAfter 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults age 18-65
- HBA1C between 5.5 and 7%.
- Altered lipid metabolism
- BMI > 25
- Signed Informed Consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized recommendations for dietPersonalized recommendations for effective diet, lifestyle and activities based on the patient's parameters measurements and reactions | Other | Personalized recommendations for diet |
Primary outcome
To determine number of participants with reduced BMI
Time frame: One year
Change at 12 months
To determine number of participants with reduced hA1C
Time frame: One year
Change at 12 months
To determine number of participants with reduced cholesterol
Time frame: One year
Change at 12 months
2 secondary outcomes
Type of intestinal microorganisms
Time frame: One year
Number of intestinal microorganisms
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naomi Keren study director
972545413328
Questions about this trial
What is this clinical trial studying?
A study testing Personalized recommendations for diet in people with Metabolic Syndrome, run by Galilee CBR.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nadya Lisovoder, MD (+972524753435, nadyal@galilee-cbr.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine number of participants with reduced BMI (time frame: One year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2017.