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NCT06683235Enrolling by invitation

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

Effect of Flaxseed Consumption as a Treatment for Adults With Type 2 Diabetes Mellitus in Oaxaca de Juárez, Oaxaca

Source: ClinicalTrials.gov · Last updated 12 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Enrolling by invitation
Study type
Interventional
Enrollment
160 (estimated)
First submitted
4 Nov 2024
Start date
Nov 2024
Primary completion date
Dec 2024
Lead sponsor
Universidad Autónoma Benito Juárez de Oaxaca
NCT number
NCT06683235

What you commit to

  • Study type: Interventional
  • Planned participants: 160
  • From Nov 2024 to the primary completion date, Dec 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients diagnosed with chronic kidney disease on renal function replacement therapy.
  • Patients with a medical history of poor drug adherence.
  • Patients who are pregnant and have gestational diabetes.

Lab values

  • Patients with glucose disorders secondary to autoimmune diabetes, thyroid diseases or insulin-producing tumors.
  • Patients with adequate glycemic control evidenced by clinical laboratory tests for at least 2 months.

Other

  • Patients who do not have a means of contact for follow-up.

Who the study is looking for

  • Oaxaca individuals between 30 and 70 years old.
  • patients who attended the Nutrition outpatient clinic at the Oaxaca Hospital President "Benito Juárez" diagnosed at most one year ago and who agreed to participate in the study by signing the informed consent.
  • Patients with a diagnosis of uncontrolled type 2 diabetes, evidenced by biochemical markers, with a maximum validity of 1 month (fasting blood glucose greater than 140 and glycosylated hemoglobin greater than 6.5%).
  • Patients with regular attendance at the outpatient clinic, for at least 3 consecutive months.

Age in the registry: 30 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Regional Presidente Juárez
Coordinator of this site? Confirm its status
Oaxaca CityMexicoUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.