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

Instituto Mexicano del Seguro Social

Status: Unknown

Conditions: Metabolic Syndrome X

Treatments: Behavioral: Normocaloric diet; Dietary Supplement: Oatmeal; Dietary Supplement: Chia

Study type: Interventional

Funder types: Other

Identifiers

NCT02480673

R-2015-785-047

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

Free diet plus Chia

Experimental group

Description:

This subjects will consume 1 cookie oatmeal with chia before breakfast and dinner for 90 days without changing their diet

Treatment:

Dietary Supplement: Chia

Normocaloric diet plus chia

Experimental group

Description:

This subjects will consume 1 cookie oatmeal with chia before breakfast and dinner for 90 days along with a normocaloric diet

Treatment:

Behavioral: Normocaloric diet

Dietary Supplement: Chia

Normocaloric diet plus oatmeal

Active Comparator group

Description:

This subjects will consume 1 cookie oatmeal before breakfast and dinner for 90 days along with a normocaloric diet

Treatment:

Behavioral: Normocaloric diet

Dietary Supplement: Oatmeal

Normocaloric diet

Active Comparator group

Description:

This subjects will only go under a normocaloric diet for 90 days

Treatment:

Behavioral: Normocaloric diet