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

Not Applicable

• Conditions: Metabolic Syndrome X
• Interventions: Dietary Supplement: Chia; Dietary Supplement: Oatmeal; Behavioral: Normocaloric diet

• Registration Number: NCT02480673
• Lead Sponsor: 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

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.

Study Timeline

• Status Verified: 2015-06
• Study Start: 2015-06
• Study First Submitted: 2015-06-22
• Study First Submitted QC: 2015-06-22
• Study First Posted: 2015-06-24
• Last Update Submitted: 2015-06-25
• Last Update Posted: 2015-06-26
• Primary Completion: 2015-12
• Study Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Free diet plus Chia	Chia	This subjects will consume 1 cookie oatmeal with chia before breakfast and dinner for 90 days without changing their diet
Normocaloric diet plus chia	Normocaloric diet	This subjects will consume 1 cookie oatmeal with chia before breakfast and dinner for 90 days along with a normocaloric diet
Normocaloric diet	Normocaloric diet	This subjects will only go under a normocaloric diet for 90 days
Normocaloric diet plus chia	Chia	This subjects will consume 1 cookie oatmeal with chia before breakfast and dinner for 90 days along with a normocaloric diet
Normocaloric diet plus oatmeal	Oatmeal	This subjects will consume 1 cookie oatmeal before breakfast and dinner for 90 days along with a normocaloric diet
Normocaloric diet plus oatmeal	Normocaloric diet	This subjects will consume 1 cookie oatmeal before breakfast and dinner for 90 days along with a normocaloric diet

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Modification in waist circumference	94 days (plus or minus 4 days)
Variation in body weight	94 days (plus or minus 4 days)
Modification in insulin resistance	94 days (plus or minus 4 days)	Serum insulin, homeostasis model assessment index
Change in diastolic blood pressure	94 days (plus or minus 4 days)
Change in systolic blood pressure	94 days (plus or minus 4 days)

Trial Locations

Locations (1)

Instituto Mexicano Del Seguro Social Hospital de Especialidades, Centro Medico Nacional de Occidente Lic. Ignacio Garcia Tellez Unidad Medica de Alta Especialidad; 🇲🇽 Guadalajara, Jalisco, Mexico