MedTrace Logo

Effect of Flaxseed as a Treatment for Adults With Type 2 Diabetes Mellitus in Mexico

NCT06683235 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2024-11-12

No results posted yet for this study

Summary

Type 2 Diabetes Mellitus represents one of the most important health emergencies of this century Although it is known that insulin resistance is reversible and that type 2 diabetes mellitus is controllable with a change towards a healthy lifestyle, the population ignores these recommendations and continues with their unhealthy habits. Thus, the number of patients continues to grow exponentially, which leads to an increase in economic expenditure on health. This is why non-pharmacological measures are sought that favor the reduction of glycemia in patients with Diabetes Mellitus where the consumption of functional foods is a good alternative for the treatment of this chronic disease. Flaxseed is a food characterized by its nutritional properties, highlighting its content of alpha linoleic acid, flax lignans, and secoisolariciresinol diglucosides. The latter have antioxidant, lipid-lowering and hypoglycemic effects, which makes it an excellent option as a functional treatment for type 2 diabetes.

The aim of this study is to assess the adjuvant effects of flaxseed consumption (14 gr of flaxseed) on biochemical markers (glucose, glycosylated hemoglobin, total cholesterol, triglycerides, LDL cholesterol and HDL cholesterol) in adult patients (30 to 70 years) with type 2 diabetes mellitus in Oaxaca.

Procedures Patients who sign the informed consent will be assigned a group according to the following: if they have an even number in their file, they will be part of the control group (A), and if they have an odd number, they will be part of the intervention group B.

Group A. They will be given a verbal instruction to continue with the treatment established by the treating physician, and they will be given nutritional guidance with the help of the healthy eating plate.

Group B. They will be given verbal instructions to continue with the treatment established by the treating physician, they will be given nutritional guidance with the help of the healthy eating plate and they will be given a leaflet with written instructions and photos on how to consume flaxseed and its benefits.

The researchers will purchase, package and provide the flaxseed powder to the members of group B. The flaxseed will be delivered in packages with 16 gr of ground flaxseed each, which will be given to the patients for daily consumption.

Conditions

  • DIABETES Mellitus Type 2 Not Well Controlled

Interventions

DIETARY_SUPPLEMENT

flaxseed

Participants in the intervention group will be given 16 g of ground flaxseed per day for 3 months.

Sponsors & Collaborators

  • Universidad Autónoma Benito Juárez de Oaxaca

    lead OTHER

Principal Investigators

  • Sabina Lopez Toledo, Doctorate · Universidad Autónoma Benito Juárez de Oaxaca (UABJO)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-30
Primary Completion
2024-12-31
Completion
2025-03-31

Countries

  • Mexico

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06683235 on ClinicalTrials.gov