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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Instituto Mexicano del Seguro Social

Current Primary Outcome:

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Instituto Mexicano del Seguro Social

Dates:
Date Received: June 22, 2015
Date Started: June 2015
Date Completion: May 2016
Last Updated: June 25, 2015
Last Verified: June 2015