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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 August 2015 |
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Main ID: |
NCT02480673 |
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Date of registration:
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22/06/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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EFFECT OF Salvia Hispanica l. (CHIA) IN THE BIOCHEMICAL METABOLIC SYNDROME COMPONENTS
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Scientific title:
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EFFECT OF Salvia Hispanica L. ( CHIA ) IN THE BIOCHEMICAL METABOLIC SYNDROME COMPONENTS IN PATIENTS IN THE NATIONAL MEDICAL CENTER WEST OF THE MEXICAN SOCIAL SECURITY INSTITUTE |
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Date of first enrolment:
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June 2015 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02480673 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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Phase:
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N/A
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Countries of recruitment
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Mexico
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Contacts
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Name:
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Ana E Pérez Verdin, MD |
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Address:
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Telephone:
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011523336170060 |
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Email:
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verdinmd@hotmail.com |
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Affiliation:
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Name:
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Ana E Perez Verdin, MD |
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Address:
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Telephone:
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011523336170060 |
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Email:
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verdinmd@hotmail.com |
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Affiliation:
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Name:
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Ana E Perez Verdin, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of metabolic syndrome according to Adult Treatment Panel - III criteria.
- Subject wishing to participate in the study by written consent.
- Instituto Mexicano del Seguro Social beneficiaries subject
- Subject who not requiring modification of medical treatment for MS in the recruitment
period.
Exclusion Criteria:
- Chronic renal failure with filtration glomerular rate clearance less than 30ml / min.
- Diabetic neuropathy.
- Post menopause
- Intestinal malabsorption diseases .
- Type 2 diabetes with HbA1c > 8.5 %
- Systolic and diastolic blood pressure >140/90 mmHg.
- Triglycerides > 300 mg/dL.
- LDL cholesterol >160mg/dL.
- Systemic autoimmune diseases .
- Cirrhosis or liver failure .
- Subject infected with human immunodeficiency virus or acquired immunodeficiency
syndrome .
- Diagnosis of cancer with active disease.
- Subject previously undergoing bariatric surgery.
- Pregnancy or lactation.
- Alcoholism and drug addiction.
- Subject who consume high fiber dietary supplements and / or omega 3 acids.
- Subject taking anorexic drugs.
- Subject under diet for weight loss implemented by a health professional.
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Metabolic Syndrome X
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Intervention(s)
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Dietary Supplement: Oatmeal
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Behavioral: Normocaloric diet
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Dietary Supplement: Chia
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Primary Outcome(s)
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Change in serum glucose levels
[Time Frame: 94 days (plus or minus 4 days)]
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Variation in lipid profile
[Time Frame: 94 days (plus or minus 4 days)]
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Secondary Outcome(s)
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Variation in body weight
[Time Frame: 94 days (plus or minus 4 days)]
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Change in diastolic blood pressure
[Time Frame: 94 days (plus or minus 4 days)]
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Change in systolic blood pressure
[Time Frame: 94 days (plus or minus 4 days)]
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Modification in insulin resistance
[Time Frame: 94 days (plus or minus 4 days)]
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Modification in waist circumference
[Time Frame: 94 days (plus or minus 4 days)]
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Secondary ID(s)
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R-2015-785-047
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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