Efect of Quinoa and Flaxseed in Cititoxicity and Glicemic Control in Metabolic Syndrome Patients

NCT03915600 | Unknown DMC

• 1 other identifier: 235/15
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

The Metabolic Syndrome (MS) is a set of anthropometric alterations and chronic-degenerative diseases, such as obesity, diabetes mellitus and arterial hypertension. Each one of the diseases and physiological alterations represents a risk factor that conditions in the medium or long term another incapacitating or limiting disease that reduces the quality of life of an individual. Our country has a growing burden of morbidity and mortality due to diseases chronic-degenerative caused, for the most part, to the unhealthy lifestyle produced by multiple factors, such as social, economic, behavioral, environmental, among others. For this reason, it is important to plan, design and implement strategies that reduce, mitigate or control this public health problem in the population. The purpose of this study is to perform a nutritional intervention that includes food such as quinoa, flaxseed or both in subjects with metabolic syndrome and follow them up for six months. The impact of this intervention will be carried out through the measurement of cytotoxicity and glycemic control, this is with the micronucleus count and the estimation of glycosylated hemoglobin (Hba1c). This document will explain in detail what is intended to be done by presenting the following sections: In the approach of the problem and the justification, the metabolic syndrome will be described, its impact on the Mexican population, the interest and relevance of this research project. In the background will be detailed what has been said and done in the different studies scientists regarding the consumption of quinoa and flaxseed. Methodology defines the strategy, conditions, clinical criteria, material and epidemiological and statistical methods for the management of subjects and information.

Conditions

Metabolic Syndrome; Nutritional and Metabolic Diseases

Keywords

Metabolic Syndrome; Micronuceli; Quinoa; Flaxseed; Diet

Outcome Measures

Primary Outcomes (3)

• Changes in the number of micronuceli after 24 weeks

  The number of micronuclei will be evaluated at baseline at 12 weeks and 24 weeks with Schmidt technique by Giemsa/wright and the entered values reflect the number of micronuclei at week 24

  24 weeks

• Changes in fasting glucose levels after 24 weeks of intervention with an added diet with quinoa or flaxseed or both or conventional diet

  The fasting glucose levels will be evaluated at baseline, at 12 weeks and 24 weeks with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at 24 weeks

  24 weeks

• Changes in glycosylated hemoglobin (A1C) after 24 weeks of intervention with an added diet with quinoa or flaxseed or both or conventional diet

  Glycosylated hemoglobin will be evaluated at baseline, at 12 weeks and 24 weeks by high-pressure liquid chromatography (HPLC) and the entered values reflect the glycosylated hemoglobin at 24 weeks

  24 weeks

Secondary Outcomes (8)

• Body Weight

  24 weeks

• Body Mass Index

  24 weeks

• Waist Circumference

  24 weeks

• Total Cholesterol

  24 weeks

• Triglycerides levels

  24 weeks

Study Arms (4)

Quinoa

EXPERIMENTAL

Personalized diet added with quinoa

Other: Quinoa

Flaxseed

EXPERIMENTAL

Personalized diet added with Flaxseed

Other: Flaxseed

Quinoa and Flaxseed

EXPERIMENTAL

Personalized diet added with quinoa and flaxseed

Other: Quinoa and Flaxseed

Normal diet

NO INTERVENTION

Personalized diet without dietary supplement

Interventions

Quinoa OTHER

Personalized diet added with quinoa

Quinoa

Flaxseed OTHER

personalized diet added with flaxseed

Flaxseed

Quinoa and Flaxseed OTHER

personalized diet added with quinoa and flaxseed

Quinoa and Flaxseed

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnostic of Metabolic Syndrome that meets at least one of the ATP-III criteria:
• Abdominal obesity over 102cm for men and over 88cm for women
• Triglycerides levels over 150mg/dl with or without treatment for dyslipidemia
• c-HDL concentration under 40mg/dl for men and under 50mg/dl for women
• Blood Pressure over 130/85mmHg
• Fasting glucose levels over 100mg/dl with or without treatment

You may not qualify if:

• Pregnant women
• Subject with other degenerative chronic diseases does not include or consider it in ATP-III criteria for Metabolic Syndrome
• Elimination Criteria
• Subjects without oral mucosa samples
• Subjects without A1c data
• Subjects without addiction to treatment under 80% with quinoa, flaxseed or both and conventional diet

Sponsors & Collaborators

• University of Guadalajara: lead
• Hospital Civil de Guadalajara: collaborator

Study Sites (2)

Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Guadalajara, Jalisco, 44280, Mexico

RECRUITING

Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara

Guadalajara, Jalisco, 44340, Mexico

RECRUITING

Related Publications (12)

• Andreassi MG, Barale R, Iozzo P, Picano E. The association of micronucleus frequency with obesity, diabetes and cardiovascular disease. Mutagenesis. 2011 Jan;26(1):77-83. doi: 10.1093/mutage/geq077.

  PMID: 21164186 BACKGROUND

• Berti C, Riso P, Monti LD, Porrini M. In vitro starch digestibility and in vivo glucose response of gluten-free foods and their gluten counterparts. Eur J Nutr. 2004 Aug;43(4):198-204. doi: 10.1007/s00394-004-0459-1. Epub 2004 Jan 6.

  PMID: 15309439 BACKGROUND

• Graf BL, Poulev A, Kuhn P, Grace MH, Lila MA, Raskin I. Quinoa seeds leach phytoecdysteroids and other compounds with anti-diabetic properties. Food Chem. 2014 Nov 15;163:178-85. doi: 10.1016/j.foodchem.2014.04.088. Epub 2014 May 4.

  PMID: 24912714 BACKGROUND

• Ezzati M, Riboli E. Behavioral and dietary risk factors for noncommunicable diseases. N Engl J Med. 2013 Sep 5;369(10):954-64. doi: 10.1056/NEJMra1203528. No abstract available.

  PMID: 24004122 BACKGROUND

• Karaman A, Aydin H, Geckinli B, Cetinkaya A, Karaman S. DNA damage is increased in lymphocytes of patients with metabolic syndrome. Mutat Res Genet Toxicol Environ Mutagen. 2015 Apr;782:30-5. doi: 10.1016/j.mrgentox.2015.03.009. Epub 2015 Mar 13.

  PMID: 25868129 BACKGROUND

• Leon-Munoz LM, Guallar-Castillon P, Lopez Garcia E, Banegas JR, Gutierrez-Fisac JL, Rodriguez-Artalejo F. Relationship of BMI, waist circumference, and weight change with use of health services by older adults. Obes Res. 2005 Aug;13(8):1398-404. doi: 10.1038/oby.2005.169.

  PMID: 16129722 BACKGROUND

• Penarrieta JM, Alvarado JA, Akesson B, Bergenstahl B. Total antioxidant capacity and content of flavonoids and other phenolic compounds in canihua (Chenopodium pallidicaule): an Andean pseudocereal. Mol Nutr Food Res. 2008 Jun;52(6):708-17. doi: 10.1002/mnfr.200700189.

  PMID: 18537130 BACKGROUND

• Rajesha J, Murthy KN, Kumar MK, Madhusudhan B, Ravishankar GA. Antioxidant potentials of flaxseed by in vivo model. J Agric Food Chem. 2006 May 31;54(11):3794-9. doi: 10.1021/jf053048a.

  PMID: 16719498 BACKGROUND

• Ranilla LG, Apostolidis E, Genovese MI, Lajolo FM, Shetty K. Evaluation of indigenous grains from the Peruvian Andean region for antidiabetes and antihypertension potential using in vitro methods. J Med Food. 2009 Aug;12(4):704-13. doi: 10.1089/jmf.2008.0122.

  PMID: 19735168 BACKGROUND

• Stewart LK, Soileau JL, Ribnicky D, Wang ZQ, Raskin I, Poulev A, Majewski M, Cefalu WT, Gettys TW. Quercetin transiently increases energy expenditure but persistently decreases circulating markers of inflammation in C57BL/6J mice fed a high-fat diet. Metabolism. 2008 Jul;57(7 Suppl 1):S39-46. doi: 10.1016/j.metabol.2008.03.003.

  PMID: 18555853 BACKGROUND

• Voss S, Hesse A, Zimmermann DJ, Sauerbruch T, von Unruh GE. Intestinal oxalate absorption is higher in idiopathic calcium oxalate stone formers than in healthy controls: measurements with the [(13)C2]oxalate absorption test. J Urol. 2006 May;175(5):1711-5. doi: 10.1016/S0022-5347(05)01001-3.

  PMID: 16600737 BACKGROUND

• Hou Y, Aboukhatwa MA, Lei DL, Manaye K, Khan I, Luo Y. Anti-depressant natural flavonols modulate BDNF and beta amyloid in neurons and hippocampus of double TgAD mice. Neuropharmacology. 2010 May;58(6):911-20. doi: 10.1016/j.neuropharm.2009.11.002. Epub 2009 Nov 14.

  PMID: 19917299 BACKGROUND

Related Links

• Epidemiología y determinantes sociales asociados a la obesidad y la diabetes tipo 2 en México
• NORMA Oficial Mexicana NOM-037-SSA2-2012, Para la prevención, tratamiento y control de las dislipidemias.
• Diferencias entre la prevalencia de obesidad y exceso de peso estimadas con datos declarados o por medición directa en adultos de la Comunidad Valenciana
• Nutraceuticals and Functional Foods in Health Promotion and Disease Risk Reduction
• Utilidad de la Prueba de Micronúcleos y Anormalidades Nucleares en Células Exfoliadas de Mucosa Oral en la Evaluación de Daño Genotóxico y Citotóxico
• Procedimientos básicos de la prueba de micronúcleos y anormalidades nucleares en células exfoliadas de mucosa oral
• Una nueva definición mundial del síndrome metabólico propuesta por la Federación Internacional de Diabetes: fundamento y resultados

MeSH Terms

Conditions

Metabolic Syndrome; Nutritional and Metabolic Diseases

Interventions

chenopodin protein, Chenopodium quinoa; Linseed Oil

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Ana Lilia Fletes Rayas, PhD

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Lilia Fletes Rayas, PhD

CONTACT

10585200; anna.fletes@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR ASSOCIATE TYPE A

Model Details: An open clinical trial with randomization plus control group

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 16, 2019
• Study Start: August 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: September 6, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (2)