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

Study Overview
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Brief Summary
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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
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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.

Official 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

Conditions
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Metabolic Syndrome X

Intervention / Treatment
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* Dietary Supplement: Chia
* Dietary Supplement: Oatmeal
* Behavioral: Normocaloric diet


Participation Criteria
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Eligibility 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Free diet plus Chia<br>This subjects will consume 1 cookie oatmeal with chia before breakfast and dinner for 90 days without changing their diet | Dietary Supplement: Chia<br>* The subject will eat 25 gr of chia in 2 oatmeal cookies at day<br>* Other names: Salvia hispanica;|
| Experimental: Normocaloric diet plus chia<br>This subjects will consume 1 cookie oatmeal with chia before breakfast and dinner for 90 days along with a normocaloric diet | Dietary Supplement: Chia<br>* The subject will eat 25 gr of chia in 2 oatmeal cookies at day<br>* Other names: Salvia hispanica;Behavioral: Normocaloric diet<br>* 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.<br>|
| Active Comparator: Normocaloric diet plus oatmeal<br>This subjects will consume 1 cookie oatmeal before breakfast and dinner for 90 days along with a normocaloric diet | Dietary Supplement: Oatmeal<br>* The subject will eat 2 oatmeal cookies a day containing the exactly same quantity of oats in the oatmeal cookies with chia.<br>* Other names: Oats;Behavioral: Normocaloric diet<br>* 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.<br>|
| Active Comparator: Normocaloric diet<br>This subjects will only go under a normocaloric diet for 90 days | Behavioral: Normocaloric diet<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum glucose levels | Fasting, postprandial and post challenge oral test glucose and HbA1c | 94 days (plus or minus 4 days) | 
| Variation in lipid profile | Triglycerides, HDL-cholesterol, LDL-cholesterol and total cholesterol | 94 days (plus or minus 4 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modification in insulin resistance | Serum insulin, homeostasis model assessment index | 94 days (plus or minus 4 days) | 
| Change in systolic blood pressure |  | 94 days (plus or minus 4 days) | 
| Change in diastolic blood pressure |  | 94 days (plus or minus 4 days) | 
| Variation in body weight |  | 94 days (plus or minus 4 days) | 
| Modification in waist circumference |  | 94 days (plus or minus 4 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chia, Metabolic Syndrome X, Dyslipidemia