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

Metabolic Syndrome X Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02480673
• Other study ID #: R-2015-785-047
• Status: Recruiting
• Phase: N/A
• First received: June 22, 2015
• Last updated: June 25, 2015
• Start date: June 2015
• Est. completion date: May 2016

Study information

• Verified date: June 2015
• Source: Instituto Mexicano del Seguro Social
• Contact: Ana E Perez Verdin, MD
• Phone: 011523336170060
• Email: verdinmd[@]hotmail.com
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Metabolic Syndrome X
• Syndrome

Intervention

Dietary Supplement:
• Chia
The subject will eat 25 gr of chia in 2 oatmeal cookies at day
• Oatmeal
The subject will eat 2 oatmeal cookies a day containing the exactly same quantity of oats in the oatmeal cookies with chia.

Behavioral:
• Normocaloric 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.

Locations

Country	Name	City	State
Mexico	Instituto Mexicano Del Seguro Social Hospital de Especialidades, Centro Medico Nacional de Occidente Lic. Ignacio Garcia Tellez Unidad Medica de Alta Especialidad	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Mexicano del Seguro Social

Country where clinical trial is conducted

Mexico, 

References & Publications (12)

Ayerza R Jr, Coates W. Effect of dietary alpha-linolenic fatty acid derived from chia when fed as ground seed, whole seed and oil on lipid content and fatty acid composition of rat plasma. Ann Nutr Metab. 2007;51(1):27-34. Epub 2007 Mar 14. — View Citation

Chicco AG, D'Alessandro ME, Hein GJ, Oliva ME, Lombardo YB. Dietary chia seed (Salvia hispanica L.) rich in alpha-linolenic acid improves adiposity and normalises hypertriacylglycerolaemia and insulin resistance in dyslipaemic rats. Br J Nutr. 2009 Jan;10 — View Citation

Guevara-Cruz M, Tovar AR, Aguilar-Salinas CA, Medina-Vera I, Gil-Zenteno L, Hernández-Viveros I, López-Romero P, Ordaz-Nava G, Canizales-Quinteros S, Guillen Pineda LE, Torres N. A dietary pattern including nopal, chia seed, soy protein, and oat reduces s — View Citation

Ho H, Lee AS, Jovanovski E, Jenkins AL, Desouza R, Vuksan V. Effect of whole and ground Salba seeds (Salvia Hispanica L.) on postprandial glycemia in healthy volunteers: a randomized controlled, dose-response trial. Eur J Clin Nutr. 2013 Jul;67(7):786-8. — View Citation

Jin F, Nieman DC, Sha W, Xie G, Qiu Y, Jia W. Supplementation of milled chia seeds increases plasma ALA and EPA in postmenopausal women. Plant Foods Hum Nutr. 2012 Jun;67(2):105-10. doi: 10.1007/s11130-012-0286-0. — View Citation

Mohd Ali N, Yeap SK, Ho WY, Beh BK, Tan SW, Tan SG. The promising future of chia, Salvia hispanica L. J Biomed Biotechnol. 2012;2012:171956. doi: 10.1155/2012/171956. Epub 2012 Nov 21. Review. — View Citation

Nieman DC, Cayea EJ, Austin MD, Henson DA, McAnulty SR, Jin F. Chia seed does not promote weight loss or alter disease risk factors in overweight adults. Nutr Res. 2009 Jun;29(6):414-8. doi: 10.1016/j.nutres.2009.05.011. — View Citation

Oliva ME, Ferreira MR, Chicco A, Lombardo YB. Dietary Salba (Salvia hispanica L) seed rich in a-linolenic acid improves adipose tissue dysfunction and the altered skeletal muscle glucose and lipid metabolism in dyslipidemic insulin-resistant rats. Prostag — View Citation

Poudyal H, Panchal SK, Waanders J, Ward L, Brown L. Lipid redistribution by a-linolenic acid-rich chia seed inhibits stearoyl-CoA desaturase-1 and induces cardiac and hepatic protection in diet-induced obese rats. J Nutr Biochem. 2012 Feb;23(2):153-62. do — View Citation

Rossi AS, Oliva ME, Ferreira MR, Chicco A, Lombardo YB. Dietary chia seed induced changes in hepatic transcription factors and their target lipogenic and oxidative enzyme activities in dyslipidaemic insulin-resistant rats. Br J Nutr. 2013 May;109(9):1617- — View Citation

Vuksan V, Jenkins AL, Dias AG, Lee AS, Jovanovski E, Rogovik AL, Hanna A. Reduction in postprandial glucose excursion and prolongation of satiety: possible explanation of the long-term effects of whole grain Salba (Salvia Hispanica L.). Eur J Clin Nutr. 2 — View Citation

Vuksan V, Whitham D, Sievenpiper JL, Jenkins AL, Rogovik AL, Bazinet RP, Vidgen E, Hanna A. Supplementation of conventional therapy with the novel grain Salba (Salvia hispanica L.) improves major and emerging cardiovascular risk factors in type 2 diabetes — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum glucose levels	Fasting, postprandial and post challenge oral test glucose and HbA1c	94 days (plus or minus 4 days)	Yes
Primary	Variation in lipid profile	Triglycerides, HDL-cholesterol, LDL-cholesterol and total cholesterol	94 days (plus or minus 4 days)	Yes
Secondary	Modification in insulin resistance	Serum insulin, homeostasis model assessment index	94 days (plus or minus 4 days)	Yes
Secondary	Change in systolic blood pressure		94 days (plus or minus 4 days)	Yes
Secondary	Change in diastolic blood pressure		94 days (plus or minus 4 days)	Yes
Secondary	Variation in body weight		94 days (plus or minus 4 days)	Yes
Secondary	Modification in waist circumference		94 days (plus or minus 4 days)	Yes