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EFFECT OF Salvia Hispanica l. (CHIA) IN THE BIOCHEMICAL METABOLIC SYNDROME COMPONENTS

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ClinicalTrials.gov Identifier: NCT02480673
Recruitment Status : Unknown
Verified June 2015 by Ana Elena Perez Verdin, Instituto Mexicano del Seguro Social.
Recruitment status was:  Recruiting
First Posted : June 24, 2015
Last Update Posted : June 26, 2015
Sponsor:
Information provided by (Responsible Party):
Ana Elena Perez Verdin, Instituto Mexicano del Seguro Social

Brief Summary:
The objective of this study is to evaluate the effect of the administration of 25 g of chia per day, for 90 days on the biochemical components of the metabolic syndrome in subjects with this condition

Condition or disease Intervention/treatment Phase
Metabolic Syndrome X Dietary Supplement: Chia Dietary Supplement: Oatmeal Behavioral: Normocaloric diet Not Applicable

Detailed Description:
The metabolic syndrome (MS) is a cardiovascular risk factor and is present in about 20-25% of the world's adult population. Individuals with this condition have twice the risk of cardiovascular disease and die from it, compared with those who do not and 5 times more likely to develop type 2 diabetes mellitus (DM2). For this reason, it is appropriate to develop better tools for prevention and management of MS, with more emphasis on lifestyle´s changes. Chia has been studied in the past 10 years due to its high concentration of omega-3 alpha-linolenic acid (ALA) and 6 linoleic acid (LA) showing beneficial effects in some components of MS in rodents and individuals. The addition of chia to the conventional treatment of MS for the modification of metabolic disorders provides us a tool for easy incorporation into daily life, inexpensive and accessible in our environment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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
Study Start Date : June 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Salvia

Arm Intervention/treatment
Experimental: Free diet plus Chia
This subjects will consume 1 cookie oatmeal with chia before breakfast and dinner for 90 days without changing their diet
Dietary Supplement: Chia
The subject will eat 25 gr of chia in 2 oatmeal cookies at day
Other Name: Salvia hispanica

Experimental: Normocaloric diet plus chia
This subjects will consume 1 cookie oatmeal with chia before breakfast and dinner for 90 days along with a normocaloric diet
Dietary Supplement: Chia
The subject will eat 25 gr of chia in 2 oatmeal cookies at day
Other Name: Salvia hispanica

Behavioral: Normocaloric diet
The healthy diet plan distribution will be 50% carbohydrate, 25 % protein, 35 % fat to less than 7 % saturated fat and less than 200 mg/d cholesterol and 20-30 g of fiber.

Active Comparator: Normocaloric diet plus oatmeal
This subjects will consume 1 cookie oatmeal before breakfast and dinner for 90 days along with a normocaloric diet
Dietary Supplement: Oatmeal
The subject will eat 2 oatmeal cookies a day containing the exactly same quantity of oats in the oatmeal cookies with chia.
Other Name: Oats

Behavioral: Normocaloric diet
The healthy diet plan distribution will be 50% carbohydrate, 25 % protein, 35 % fat to less than 7 % saturated fat and less than 200 mg/d cholesterol and 20-30 g of fiber.

Active Comparator: Normocaloric diet
This subjects will only go under a normocaloric diet for 90 days
Behavioral: Normocaloric diet
The healthy diet plan distribution will be 50% carbohydrate, 25 % protein, 35 % fat to less than 7 % saturated fat and less than 200 mg/d cholesterol and 20-30 g of fiber.




Primary Outcome Measures :
  1. Change in serum glucose levels [ Time Frame: 94 days (plus or minus 4 days) ]
    Fasting, postprandial and post challenge oral test glucose and HbA1c

  2. Variation in lipid profile [ Time Frame: 94 days (plus or minus 4 days) ]
    Triglycerides, HDL-cholesterol, LDL-cholesterol and total cholesterol


Secondary Outcome Measures :
  1. Modification in insulin resistance [ Time Frame: 94 days (plus or minus 4 days) ]
    Serum insulin, homeostasis model assessment index

  2. Change in systolic blood pressure [ Time Frame: 94 days (plus or minus 4 days) ]
  3. Change in diastolic blood pressure [ Time Frame: 94 days (plus or minus 4 days) ]
  4. Variation in body weight [ Time Frame: 94 days (plus or minus 4 days) ]
  5. Modification in waist circumference [ Time Frame: 94 days (plus or minus 4 days) ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02480673


Contacts
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Contact: Ana E Perez Verdin, MD 011523336170060 ext 31465 verdinmd@hotmail.com
Contact: Blanca M Torres Mendoza, PhD 011523336170060 ext 31950 bltorres1@hotmail.com

Locations
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Mexico
Instituto Mexicano Del Seguro Social Hospital de Especialidades, Centro Medico Nacional de Occidente Lic. Ignacio Garcia Tellez Unidad Medica de Alta Especialidad Recruiting
Guadalajara, Jalisco, Mexico, 44340
Contact: Ana E Pérez Verdin, MD    011523336170060 ext 31465    verdinmd@hotmail.com   
Contact: Blanca M Torres Mendoza, PhD    011523336170060 ext 31950    bltorres1@hotmail.com   
Sponsors and Collaborators
Instituto Mexicano del Seguro Social
Investigators
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Principal Investigator: Ana E Perez Verdin, MD
Publications of Results:

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Responsible Party: Ana Elena Perez Verdin, Dr., Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier: NCT02480673    
Other Study ID Numbers: R-2015-785-047
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: June 26, 2015
Last Verified: June 2015
Keywords provided by Ana Elena Perez Verdin, Instituto Mexicano del Seguro Social:
Metabolic Syndrome X
Chia
Dyslipidemia
Additional relevant MeSH terms:
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Microvascular Angina
Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases