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

NCT06683235 | Enrolling By Invitation

• 1 other identifier: CEI-04/2023
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

DIABETES MELLITUS; Functional foods; metformin; biochemical markers; flax

Outcome Measures

Primary Outcomes (4)

• Fasting glucose concentration

  Normal 70 - 99 mg/ dl Prediabetes 100 - 125 mg/ dl Diabetes \>126 mg/dl

  Base and through study completion, an average of 12 weeks

• Glycosylated hemoglobin concentration

  Normal \<5.6% Prediabetes 5.7 % - 6.4 % Diabetes \>6.5%

  Base and through study completion, an average of 12 weeks

• Total cholesterol concentration

  Normal values should be less than 200 mg/dl

  Base and through study completion, an average of 12 weeks

• Triglycerides concentration

  Normal values should be less than 150 milligrams per deciliter (mg/dl) in adults

  Base and through study completion, an average of 12 weeks

Study Arms (2)

Intervention with flaxseed

EXPERIMENTAL

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

Dietary Supplement: flaxseed

Control group

NO INTERVENTION

control group, without intervention.

Interventions

flaxseed DIETARY_SUPPLEMENT

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

Intervention with flaxseed

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients diagnosed with chronic kidney disease on renal function replacement therapy.
• Patients with glucose disorders secondary to autoimmune diabetes, thyroid diseases or insulin-producing tumors.
• Patients with a medical history of poor drug adherence.
• Patients with adequate glycemic control evidenced by clinical laboratory tests for at least 2 months.
• Patients who do not have a means of contact for follow-up.
• Patients who are pregnant and have gestational diabetes.

Sponsors & Collaborators

• Universidad Autónoma Benito Juárez de Oaxaca: lead

Study Sites (1)

Hospital Regional Presidente Juárez

Oaxaca City, Oaxaca, 68024, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Linseed Oil

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Sabina Lopez Toledo, Doctorate

  Universidad Autónoma Benito Juárez de Oaxaca (UABJO)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Investigator

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 12, 2024
• Study Start: November 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: supporting information will be available (March 2025) and for 1 year (March 2026).
• Access Criteria: The main researcher will have the information stored in his laboratory for one year. Researchers who want the information may request it

Locations

ME (1)