NCT03915600

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

Status unknown NA Last updated 6 September 2019

What this trial tests

NA trial testing Quinoa in Metabolic Syndrome in 90 participants. Status unknown.

Timeline

1 August 2019

Primary endpoint
31 December 2020

31 December 2020

Quick facts

Lead sponsor	University of Guadalajara
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	90
Start date	1 August 2019
Primary completion	31 December 2020
Estimated completion	31 December 2020
Sites	2 locations across Mexico

Drugs / interventions tested

• Quinoa
• Flaxseed — full drug profile →
• Quinoa and Flaxseed

Conditions studied

• Metabolic Syndrome — all drugs for Metabolic Syndrome →
• Nutritional and Metabolic Diseases — all drugs for Nutritional and Metabolic Diseases →

Sponsor

University of Guadalajara

Who can join

Adults 30 to 60, any sex, with Metabolic Syndrome or Nutritional and Metabolic Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.