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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03915600
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
Hospital Civil de Guadalajara
Information provided by (Responsible Party):
Ana Lilia Fletes Rayas, University of Guadalajara

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.


Condition or disease Intervention/treatment Phase
Metabolic Syndrome Nutritional and Metabolic Diseases Other: Quinoa Other: Flaxseed Other: Quinoa and Flaxseed Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: An open clinical trial with randomization plus control group
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Citotoxicity and Clicemic Control of Subject With Metabolic Syndrome Managed With Conventional Nutritional Tratment More Quinoa, Flaxseed or Borh Versus Conventional Nutrition
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Quinoa
Personalized diet added with quinoa
Other: Quinoa
Personalized diet added with quinoa

Experimental: Flaxseed
Personalized diet added with Flaxseed
Other: Flaxseed
personalized diet added with flaxseed

Experimental: Quinoa and Flaxseed
Personalized diet added with quinoa and flaxseed
Other: Quinoa and Flaxseed
personalized diet added with quinoa and flaxseed

No Intervention: Normal diet
Personalized diet without dietary supplement



Primary Outcome Measures :
  1. Changes in the number of micronuceli after 24 weeks [ Time Frame: 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

  2. Changes in fasting glucose levels after 24 weeks of intervention with an added diet with quinoa or flaxseed or both or conventional diet [ Time Frame: 24 weeks ]
    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

  3. Changes in glycosylated hemoglobin (A1C) after 24 weeks of intervention with an added diet with quinoa or flaxseed or both or conventional diet [ Time Frame: 24 weeks ]
    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


Secondary Outcome Measures :
  1. Body Weight [ Time Frame: 24 weeks ]
    The body weight will be measured at baseline, at 12 weeks and 24 weeks with a bioimpedance balance and the entered values reflect the body weight at 24 weeks

  2. Body Mass Index [ Time Frame: 24 weeks ]
    Body Mass Index will be calculated at baseline, 12 weeks and 24 weeks with the Quetelet index formula and the entered values reflect the body mass index at 24 weeks

  3. Waist Circumference [ Time Frame: 24 weeks ]
    Waist circumference will be evaluated at baseline and at 24 weeks with a flexible tape

  4. Total Cholesterol [ Time Frame: 24 weeks ]
    Total cholesterol levels will be evaluated at baseline and 24 weeks by enzymatic/colorimetric techniques and the entered values reflect the total cholesterol level at 24 weeks

  5. Triglycerides levels [ Time Frame: 24 weeks ]
    Triglycerides levels will be evaluated at baseline and 24 weeks with enzymatic/colorimetric techniques and the entered values reflect the triglycerides level at 24 weeks

  6. High Density Lipoprotein [ Time Frame: 24 weeks ]
    c-HDL levels will be evaluated at baseline and 24 weeks with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at 24 weeks

  7. Low Density Lipoproteins [ Time Frame: 24 weeks ]
    c-LDL levels will be evaluated at baseline and 24 weeks with enzymatic/colorimetric techniques and the entered values reflect the c-LDL level at 24 weeks

  8. Blood pressure [ Time Frame: 24 weeks ]
    Blood pressure will be measured at baseline and 24 weeks with a digital sphygmomanometer and the entered values reflect the blood pressure at 24 weeks



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915600


Contacts
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Contact: Ana Lilia Fletes Rayas, PhD 10585200 ext 34097 anna.fletes@hotmail.com

Locations
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Mexico
Hospital Civil de Guadalajara "Fray Antonio Alcalde" Recruiting
Guadalajara, Jalisco, Mexico, 44280
Contact: Claudia Elizabeth Granados Manzo, N.E.N.C.    +52 3312656388      
Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara Recruiting
Guadalajara, Jalisco, Mexico, 44340
Contact: Ana Lilia Fletes Rayas, Ph. D.    10585200 ext 34098    anna.fletes@gmail.com   
Sub-Investigator: Abraham Eduardo Coldivar Gabriel, Lic. en Enf         
Sub-Investigator: Lizet Yadira Rosales Rivera, M.D. Ph. D         
Sub-Investigator: José de Jesús Lopez, Ph. D.         
Sponsors and Collaborators
University of Guadalajara
Hospital Civil de Guadalajara
Investigators
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Principal Investigator: Ana Lilia Fletes Rayas, PhD University of Guadalajara
Additional Information:
Publications:

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Responsible Party: Ana Lilia Fletes Rayas, PROFESSOR ASSOCIATE TYPE A, University of Guadalajara
ClinicalTrials.gov Identifier: NCT03915600    
Other Study ID Numbers: 235/15
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: El uso de los datos es exclusivo de los investigadores involucrados en el estudio sin la devulgacion de los mismos a terceros externos al equipo de trabajo

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ana Lilia Fletes Rayas, University of Guadalajara:
Metabolic Syndrome
Micronuceli
Quinoa
Flaxseed
Diet
Additional relevant MeSH terms:
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Metabolic Syndrome
Metabolic Diseases
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders