DIABETES Mellitus Type 2 Not Well ControlledNCT06683235
Effect of Flaxseed as a Treatment for Adults With Type 2 Diabetes Mellitus in Mexico
A study testing flaxseed in people with DIABETES Mellitus Type 2 Not Well Controlled, run by Universidad Autónoma Benito Juárez de Oaxaca at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- DIABETES Mellitus Type 2 Not Well Controlled
- What is being tested?
- flaxseed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteMexico
- Study dates
- Nov 2024to Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Flaxseed Consumption as a Treatment for Adults With Type 2 Diabetes Mellitus in Oaxaca de Juárez, Oaxaca
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.
Read more
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.
Read the detailed description
Researchers Dra. Sabina López Toledo (Responsible) Maria Cruz Pineda De la Cruz General objective 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, who attend the Nutrition outpatient clinic of the Regional Hospital in Oaxaca.
Specific objectives
- To describe the sociodemographic variables (age, sex, occupation, marital status) of adult patients (30 to 70 years) with type 2 diabetes, who attend the Nutrition outpatient clinic of the Regional Hospital in Oaxaca.
- Describe the clinical characteristics (time of disease evolution, type of treatment, control and comorbidities) of adult patients (30 to 70 years) with type 2 diabetes who attend the Nutrition outpatient clinic of the Regional Hospital in Oaxaca.
- Assess the biochemical parameters (glucose, glycosylated hemoglobin, total cholesterol, triglycerides, LDL cholesterol and HDL cholesterol) of adult patients (30 to 70 years) with type 2 diabetes who attend the Nutrition outpatient clinic of the Regional Hospital in Oaxaca, prior to consuming flaxseed and three months after regular consumption of flaxseed.
- Apply a nutritional intervention to two groups: Group A) Teaching about the healthy eating plate and Group B) Teaching about the healthy eating plate and indicating the consumption of flaxseed.
- To evaluate the effect of flaxseed consumption on biochemical markers (glucose, glycosylated hemoglobin, total cholesterol, triglycerides, LDL cholesterol and HDL cholesterol of adult patients (30 to 70 years) suffering from type 2 diabetes, who attend the Nutrition outpatient clinic of the Regional Hospital in Oaxaca.
- To analyze the most effective possible combinations (pharmacological + non-pharmacological) for the treatment of adult patients (30 to 70 years) suffering from type 2 diabetes, who attend the Nutrition outpatient clinic of the Regional Hospital in Oaxaca.
Justification Type 2 Diabetes Mellitus represents one of the most important health emergencies of this century. It is estimated that in 2019 there were already 463 million people with diabetes mellitus worldwide and that this figure may increase to 578 million by 2030 and 700 million by 2030. million by 2045. A state of hyperglycemia is associated with acute and chronic complications, in both cases affecting the cardiovascular system, mainly the blood vessels and consequently the entire body, but mainly the eyes, kidneys, arteriovenous systems and peripheral nerves. 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.
Description of the 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.
Phase 3. Flaxseed administration 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 (one 8 gr spoonful of flaxseed in the morning snack and one 10 gr spoonful of flaxseed in the morning snack).
- Being tested
- flaxseed
- Keywords
- DIABETES MELLITUS, Functional foods, metformin, biochemical markers, flax
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flaxseedDietary supplement
Participants in the intervention group will be given 16 g of ground flaxseed per day for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention with flaxseed | Experimental | Participants in the intervention group will be given 16 g of ground flaxseed per day for 3 months. Receives: Dietary Supplement: flaxseed |
| Control group | No intervention | control group, without intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting glucose concentration
Normal 70 - 99 mg/ dl Prediabetes 100 - 125 mg/ dl Diabetes >126 mg/dl
Measured: Base and through study completion, an average of 12 weeks
Glycosylated hemoglobin concentration
Normal <5.6% Prediabetes 5.7 % - 6.4 % Diabetes >6.5%
Measured: Base and through study completion, an average of 12 weeks
Total cholesterol concentration
Normal values should be less than 200 mg/dl
Measured: 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
Measured: Base and through study completion, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study startNov 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DIABETES Mellitus Type 2 Not Well ControlledStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autónoma Benito Juárez de Oaxaca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabina López Toledo, Universidad Autónoma Benito Juárez de Oaxaca
- Investigators
- Sabina Lopez Toledo, Doctorate, Principal investigator, Universidad Autónoma Benito Juárez de Oaxaca (UABJO)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683235
- Sponsor's protocol ID
- CEI-04/2023
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The plan to make the study available is to publish scientific articles in journals with high scientific rigor. The data will also be uploaded to Mexico's national data repository. A data dictionary (a description of the variables, or types of data, collected for each individual) will be provided so that the data can be fully interpreted. The main researcher will also have the information stored in his laboratory for one year. Researchers who want the information may request it by email
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Flaxseed Consumption as a Treatment for Adults With Type 2 Diabetes Mellitus in Oaxaca de Juárez, Oaxaca
- ClinicalTrials.gov ID
- NCT06683235
- Acronym / sponsor ID
- CEI-04/2023
- Keywords
- DIABETES MELLITUS, Functional foods, metformin, biochemical markers, flax
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Universidad Autónoma Benito Juárez de OaxacaUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Researchers Dra. Sabina López Toledo (Responsible) Maria Cruz Pineda De la Cruz General objective 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, who attend the Nutrition outpatient clinic of the Regional Hospital in Oaxaca.
Specific objectives
- To describe the sociodemographic variables (age, sex, occupation, marital status) of adult patients (30 to 70 years) with type 2 diabetes, who attend the Nutrition outpatient clinic of the Regional Hospital in Oaxaca.
- Describe the clinical characteristics (time of disease evolution, type of treatment, control and comorbidities) of adult patients (30 to 70 years) with type 2 diabetes who attend the Nutrition outpatient clinic of the Regional Hospital in Oaxaca.
- Assess the biochemical parameters (glucose, glycosylated hemoglobin, total cholesterol, triglycerides, LDL cholesterol and HDL cholesterol) of adult patients (30 to 70 years) with type 2 diabetes who attend the Nutrition outpatient clinic of the Regional Hospital in Oaxaca, prior to consuming flaxseed and three months after regular consumption of flaxseed.
- Apply a nutritional intervention to two groups: Group A) Teaching about the healthy eating plate and Group B) Teaching about the healthy eating plate and indicating the consumption of flaxseed.
- To evaluate the effect of flaxseed consumption on biochemical markers (glucose, glycosylated hemoglobin, total cholesterol, triglycerides, LDL cholesterol and HDL cholesterol of adult patients (30 to 70 years) suffering from type 2 diabetes, who attend the Nutrition outpatient clinic of the Regional Hospital in Oaxaca.
- To analyze the most effective possible combinations (pharmacological + non-pharmacological) for the treatment of adult patients (30 to 70 years) suffering from type 2 diabetes, who attend the Nutrition outpatient clinic of the Regional Hospital in Oaxaca.
Justification Type 2 Diabetes Mellitus represents one of the most important health emergencies of this century. It is estimated that in 2019 there were already 463 million people with diabetes mellitus worldwide and that this figure may increase to 578 million by 2030 and 700 million by 2030. million by 2045. A state of hyperglycemia is associated with acute and chronic complications, in both cases affecting the cardiovascular system, mainly the blood vessels and consequently the entire body, but mainly the eyes, kidneys, arteriovenous systems and peripheral nerves. 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.
Description of the 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.
Phase 3. Flaxseed administration 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 (one 8 gr spoonful of flaxseed in the morning snack and one 10 gr spoonful of flaxseed in the morning snack).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention with flaxseed | Experimental | Dietary Supplement: flaxseedParticipants in the intervention group will be given 16 g of ground flaxseed per day for 3 months. |
| Control group | No intervention | –control group, without intervention. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flaxseedParticipants in the intervention group will be given 16 g of ground flaxseed per day for 3 months. | Dietary supplement | Intervention with flaxseed |
Primary outcome
Fasting glucose concentration
Time frame: 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
Time frame: Base and through study completion, an average of 12 weeks
Normal <5.6% Prediabetes 5.7 % - 6.4 % Diabetes >6.5%
Total cholesterol concentration
Time frame: Base and through study completion, an average of 12 weeks
Normal values should be less than 200 mg/dl
Triglycerides concentration
Time frame: Base and through study completion, an average of 12 weeks
Normal values should be less than 150 milligrams per deciliter (mg/dl) in adults
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: Yes. The plan to make the study available is to publish scientific articles in journals with high scientific rigor. The data will also be uploaded to Mexico's national data repository. A data dictionary (a description of the variables, or types of data, collected for each individual) will be provided so that the data can be fully interpreted. The main researcher will also have the information stored in his laboratory for one year. Researchers who want the information may request it by email
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sabina Lopez Toledo, Doctorate principal investigator
Universidad Autónoma Benito Juárez de Oaxaca (UABJO)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing flaxseed in people with DIABETES Mellitus Type 2 Not Well Controlled, run by Universidad Autónoma Benito Juárez de Oaxaca at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting glucose concentration (time frame: Base and through study completion, an average of 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.