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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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.

Eligibility

Primary outcome measure(s)

• Fasting glucose concentration — Base and through study completion, an average of 12 weeks
  Normal 70 - 99 mg/ dl Prediabetes 100 - 125 mg/ dl Diabetes \>126 mg/dl
• Glycosylated hemoglobin concentration — Base and through study completion, an average of 12 weeks
  Normal \<5.6% Prediabetes 5.7 % - 6.4 % Diabetes \>6.5%
• Total cholesterol concentration — Base and through study completion, an average of 12 weeks
  Normal values should be less than 200 mg/dl
• Triglycerides concentration — Base and through study completion, an average of 12 weeks
  Normal values should be less than 150 milligrams per deciliter (mg/dl) in adults

Trial sites (1)