NCT02480673

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 26, 2015

Status Verified

June 1, 2015

Enrollment Period

6 months

First QC Date

June 22, 2015

Last Update Submit

June 25, 2015

Conditions

Metabolic Syndrome X

Keywords

Metabolic Syndrome XChiaDyslipidemia

Outcome Measures

Primary Outcomes (2)

  • Change in serum glucose levels

    Fasting, postprandial and post challenge oral test glucose and HbA1c

    94 days (plus or minus 4 days)

  • Variation in lipid profile

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

    94 days (plus or minus 4 days)

Secondary Outcomes (5)

  • Modification in insulin resistance

    94 days (plus or minus 4 days)

  • Change in systolic blood pressure

    94 days (plus or minus 4 days)

  • Change in diastolic blood pressure

    94 days (plus or minus 4 days)

  • Variation in body weight

    94 days (plus or minus 4 days)

  • Modification in waist circumference

    94 days (plus or minus 4 days)

Study Arms (4)

Free diet plus Chia

EXPERIMENTAL

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

Dietary Supplement: Chia

Normocaloric diet plus chia

EXPERIMENTAL

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

Dietary Supplement: ChiaBehavioral: Normocaloric diet

Normocaloric diet plus oatmeal

ACTIVE COMPARATOR

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

Dietary Supplement: OatmealBehavioral: Normocaloric diet

Normocaloric diet

ACTIVE COMPARATOR

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

Behavioral: Normocaloric diet

Interventions

ChiaDIETARY_SUPPLEMENT

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

Also known as: Salvia hispanica
Free diet plus ChiaNormocaloric diet plus chia
OatmealDIETARY_SUPPLEMENT

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

Also known as: Oats
Normocaloric diet plus oatmeal
Normocaloric dietBEHAVIORAL

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.

Normocaloric dietNormocaloric diet plus chiaNormocaloric diet plus oatmeal

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (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, 44340, Mexico

RECRUITING

Related Publications (12)

  • 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.

    PMID: 23251075RESULT

  • 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.

    PMID: 17356263RESULT

  • 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.

    PMID: 18492301RESULT

  • 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.

    PMID: 22947172RESULT

  • 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.

    PMID: 24120122RESULT

  • 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.

    PMID: 21429727RESULT

  • 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.

    PMID: 17686832RESULT

  • 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.

    PMID: 19628108RESULT

  • 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.

    PMID: 22538527RESULT

  • 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.

    PMID: 20087375RESULT

  • 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.

    PMID: 23778782RESULT

  • 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.

    PMID: 22090467RESULT

MeSH Terms

Conditions

Metabolic SyndromeDyslipidemias

Interventions

Salvia hispanica seed extract

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesLipid Metabolism Disorders

Study Officials

  • Ana E Perez Verdin, MD

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana E Perez Verdin, MD

CONTACT

011523336170060verdinmd@hotmail.com

Blanca M Torres Mendoza, PhD

CONTACT

011523336170060bltorres1@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

June 22, 2015

First Posted

June 24, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2015

Study Completion

May 1, 2016

Last Updated

June 26, 2015

Record last verified: 2015-06

Locations

ME(1)