Metabolic Syndrome X
Conditions
Keywords
Metabolic Syndrome X, Chia, Dyslipidemia
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.
Interventions
DIETARY_SUPPLEMENTChia
The subject will eat 25 gr of chia in 2 oatmeal cookies at day
DIETARY_SUPPLEMENTOatmeal
The subject will eat 2 oatmeal cookies a day containing the exactly same quantity of oats in the oatmeal cookies with chia.
BEHAVIORALNormocaloric 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.
Sponsors
Instituto Mexicano del Seguro Social
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum glucose levels | 94 days (plus or minus 4 days) | Fasting, postprandial and post challenge oral test glucose and HbA1c |
| Variation in lipid profile | 94 days (plus or minus 4 days) | Triglycerides, HDL-cholesterol, LDL-cholesterol and total cholesterol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in diastolic blood pressure | 94 days (plus or minus 4 days) | — |
| Modification in insulin resistance | 94 days (plus or minus 4 days) | Serum insulin, homeostasis model assessment index |
| Modification in waist circumference | 94 days (plus or minus 4 days) | — |
| Variation in body weight | 94 days (plus or minus 4 days) | — |
| Change in systolic blood pressure | 94 days (plus or minus 4 days) | — |
Countries
Mexico
Contacts
Primary ContactAna E Perez Verdin, MD
Backup ContactBlanca M Torres Mendoza, PhD
Outcome results
None listed