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Flaxseed Consumption for Type 2 Diabetes Management in Adults

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What is being tested

flaxseed

Dietary Supplement
Who is being recruted

Diabetes Mellitus+2

+ Endocrine System Diseases

+ Metabolic Diseases

From 30 to 70 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: November 2024
See protocol details

Summary

Principal SponsorUniversidad Autónoma Benito Juárez de Oaxaca
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2024

Actual date on which the first participant was enrolled.

This study aims to evaluate the effects of flaxseed consumption on adults aged 30 to 70 years with type 2 diabetes mellitus in Oaxaca, Mexico. Flaxseed is a food known for its nutritional properties, including components that may help to lower blood sugar and cholesterol levels. The study focuses on understanding how flaxseed can improve various health markers like glucose, cholesterol, and triglycerides in these patients. This research is important because type 2 diabetes is a growing health concern, and finding effective non-drug treatments could help manage the disease better and reduce healthcare costs. Participants in this study are divided into two groups based on the number in their health record. Group A will receive standard care and nutritional guidance using the healthy eating plate model. Group B will receive the same nutritional guidance plus 16 grams of ground flaxseed daily. The flaxseed is given in powder form, to be consumed as part of a morning snack. Researchers will monitor changes in health indicators like blood sugar and cholesterol before and after three months of flaxseed consumption. This approach will help determine if flaxseed is a beneficial addition to the treatment regimen for type 2 diabetes.

Official TitleEffect of Flaxseed Consumption as a Treatment for Adults With Type 2 Diabetes Mellitus in Oaxaca de Juárez, Oaxaca
NCT06683235
Principal SponsorUniversidad Autónoma Benito Juárez de Oaxaca
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

160 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 30 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusEndocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

4 inclusion criteria required to participate
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.
6 exclusion criteria prevent from participating
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.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Hospital Regional Presidente Juárez

Oaxaca City, MexicoOpen Hospital Regional Presidente Juárez in Google Maps
Enrolling by invitationOne Study Center