Clinical trial NCT02480673: EFFECT OF Salvia Hispanica l. (CHIA) IN THE BIOCHEMICAL METABOLIC SYNDROME COMPONENTS
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome X
Keywords: Metabolic Syndrome X
Chia
Dyslipidemia
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2015-06-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility 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.

Primary outcomes:
measure: Change in serum glucose levels
timeFrame: 94 days (plus or minus 4 days)
measure: Variation in lipid profile
timeFrame: 94 days (plus or minus 4 days)
Secondary outcomes:
measure: Modification in insulin resistance
timeFrame: 94 days (plus or minus 4 days)
measure: Change in systolic blood pressure
timeFrame: 94 days (plus or minus 4 days)
measure: Change in diastolic blood pressure
timeFrame: 94 days (plus or minus 4 days)
measure: Variation in body weight
timeFrame: 94 days (plus or minus 4 days)
measure: Modification in waist circumference
timeFrame: 94 days (plus or minus 4 days)
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Instituto Mexicano Del Seguro Social Hospital de Especialidades, Centro Medico Nacional de Occidente Lic. Ignacio Garcia Tellez Unidad Medica de Alta Especialidad
state: Jalisco
Study officials:
name: Ana E Perez Verdin, MD
role: PRINCIPAL_INVESTIGATOR
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