Back to results

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

Primary Purpose

Metabolic Syndrome X

Status

Unknown status

Phase

Not Applicable

Locations

Mexico

Study Type

Interventional

Intervention

Chia

Oatmeal

Normocaloric diet

About this trial

This is an interventional supportive care trial for Metabolic Syndrome X focused on measuring Metabolic Syndrome X, Chia, Dyslipidemia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

Instituto Mexicano Del Seguro Social Hospital de Especialidades, Centro Medico Nacional de Occidente Lic. Ignacio Garcia Tellez Unidad Medica de Alta EspecialidadRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Free diet plus Chia

Normocaloric diet plus chia

Normocaloric diet plus oatmeal

Normocaloric diet

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Change in serum glucose levels

Fasting, postprandial and post challenge oral test glucose and HbA1c

Variation in lipid profile

Triglycerides, HDL-cholesterol, LDL-cholesterol and total cholesterol

Secondary Outcome Measures

Modification in insulin resistance

Serum insulin, homeostasis model assessment index

Change in systolic blood pressure

Change in diastolic blood pressure

Variation in body weight

Modification in waist circumference

Full Information

NCT ID

NCT02480673

First Posted

June 22, 2015

Last Updated

June 25, 2015

Sponsor

Instituto Mexicano del Seguro Social

1. Study Identification

Unique Protocol Identification Number

NCT02480673

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Unknown status

Study Start Date

June 2015 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

May 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Instituto Mexicano del Seguro Social

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome X

Keywords

Metabolic Syndrome X, Chia, Dyslipidemia

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Free diet plus Chia

Arm Type

Experimental

Arm Description

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

Arm Title

Normocaloric diet plus chia

Arm Type

Experimental

Arm Description

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

Arm Title

Normocaloric diet plus oatmeal

Arm Type

Active Comparator

Arm Description

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

Arm Title

Normocaloric diet

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Chia

Other Intervention Name(s)

Salvia hispanica

Intervention Description

The subject will eat 25 gr of chia in 2 oatmeal cookies at day

Intervention Type

Dietary Supplement

Intervention Name(s)

Oatmeal

Other Intervention Name(s)

Oats

Intervention Description

The subject will eat 2 oatmeal cookies a day containing the exactly same quantity of oats in the oatmeal cookies with chia.

Intervention Type

Behavioral

Intervention Name(s)

Normocaloric diet

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in serum glucose levels

Description

Fasting, postprandial and post challenge oral test glucose and HbA1c

Time Frame

94 days (plus or minus 4 days)

Title

Variation in lipid profile

Description

Triglycerides, HDL-cholesterol, LDL-cholesterol and total cholesterol

Time Frame

94 days (plus or minus 4 days)

Secondary Outcome Measure Information:

Title

Modification in insulin resistance

Description

Serum insulin, homeostasis model assessment index

Time Frame

94 days (plus or minus 4 days)

Title

Change in systolic blood pressure

Time Frame

94 days (plus or minus 4 days)

Title

Change in diastolic blood pressure

Time Frame

94 days (plus or minus 4 days)

Title

Variation in body weight

Time Frame

94 days (plus or minus 4 days)

Title

Modification in waist circumference

Time Frame

94 days (plus or minus 4 days)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ana E Perez Verdin, MD

Phone

011523336170060

Ext

31465

verdinmd@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Blanca M Torres Mendoza, PhD

Phone

011523336170060

Ext

31950

bltorres1@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ana E Perez Verdin, MD

Official's Role

Principal Investigator

Facility Information:

Facility Name

Instituto Mexicano Del Seguro Social Hospital de Especialidades, Centro Medico Nacional de Occidente Lic. Ignacio Garcia Tellez Unidad Medica de Alta Especialidad

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44340

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ana E Pérez Verdin, MD

Phone

011523336170060

Ext

31465

verdinmd@hotmail.com

First Name & Middle Initial & Last Name & Degree

Blanca M Torres Mendoza, PhD

Phone

011523336170060

Ext

31950

bltorres1@hotmail.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

23251075

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.

Results Reference

result

PubMed Identifier

17356263

Citation

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. doi: 10.1159/000100818. Epub 2007 Mar 14.

Results Reference

result

PubMed Identifier

18492301

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;101(1):41-50. doi: 10.1017/S000711450899053X. Epub 2008 May 20.

Results Reference

result

PubMed Identifier

22947172

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):1617-27. doi: 10.1017/S0007114512003558. Epub 2012 Sep 5.

Results Reference

result

PubMed Identifier

24120122

Citation

Oliva ME, Ferreira MR, Chicco A, Lombardo YB. Dietary Salba (Salvia hispanica L) seed rich in alpha-linolenic acid improves adipose tissue dysfunction and the altered skeletal muscle glucose and lipid metabolism in dyslipidemic insulin-resistant rats. Prostaglandins Leukot Essent Fatty Acids. 2013 Oct;89(5):279-89. doi: 10.1016/j.plefa.2013.09.010. Epub 2013 Sep 25.

Results Reference

result

PubMed Identifier

21429727

Citation

Poudyal H, Panchal SK, Waanders J, Ward L, Brown L. Lipid redistribution by alpha-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. doi: 10.1016/j.jnutbio.2010.11.011. Epub 2011 Mar 22.

Results Reference

result

PubMed Identifier

17686832

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: results of a randomized controlled trial. Diabetes Care. 2007 Nov;30(11):2804-10. doi: 10.2337/dc07-1144. Epub 2007 Aug 8.

Results Reference

result

PubMed Identifier

19628108

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.

Results Reference

result

PubMed Identifier

22538527

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.

Results Reference

result

PubMed Identifier

20087375

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. 2010 Apr;64(4):436-8. doi: 10.1038/ejcn.2009.159. Epub 2010 Jan 20.

Results Reference

result

PubMed Identifier

23778782

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. doi: 10.1038/ejcn.2013.103. Epub 2013 Jun 19.

Results Reference

result

PubMed Identifier

22090467

Citation

Guevara-Cruz M, Tovar AR, Aguilar-Salinas CA, Medina-Vera I, Gil-Zenteno L, Hernandez-Viveros I, Lopez-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 serum triglycerides and glucose intolerance in patients with metabolic syndrome. J Nutr. 2012 Jan;142(1):64-9. doi: 10.3945/jn.111.147447. Epub 2011 Nov 16.

Results Reference

result

Learn more about this trial

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

We'll reach out to this number within 24 hrs