Prediabetic StateLINAPREDNCT05245825
Flaxseed Supplementation in Prediabetic Adults (LINAPRED)
A study testing Flaxseed and Dietary plan in people with Prediabetic State, run by Centro Universitario de Ciencias de la Salud, Mexico at 1 site in Mexico.
Trial summary
Prediabetes is the term used to describe the condition where blood glucose level is higher than normal but lower than the diagnosis criteria of type 2 diabetes mellitus (T2DM). This condition confers a high risk for the development of T2DM and other diseases. Read more about this study
- Who is it for?
- Ages 30 to 59 years
- Conditions the study is for
- Prediabetic State
- What is being tested?
- Flaxseed and Dietary plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteMexico
- Study dates
- 20 Nov 2021to 20 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who agree to participate in the study once they have read and signed the informed consent
- Men and women
- Fasting glucose levels between 100 and 125 mg/dl
- Age 30-59 years
- Stable weight in the last 3 months (no more than 5% weight change)
Who cannot join
- Fasting glucose <100 and >125 mg/dl
- Anemia
- Consumption of drugs that may modify glucose levels
- Consumption of flaxseed, chia, or omega-3, three months before the study
- Alternative diets (vegetarian, vegan, ketogenic, etc.)
- Pregnancy and breastfeeding
- Allergy or intolerance to flaxseed
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Universidad de Guadalajara (CUCS)
Guadalajara, Jalisco, 44340
Gabriela Macedo, PhD, +523310585200 ext. 33900, gabriela.macedo@cucs.udg.mx
Yareni Zuñiga, PhD, +523336190635 ext. 145, lauray.zuniga@academicos.udg.mx
About this study
Official title: Effect of Flaxseed Supplementation on Glycemic Control in Prediabetic Adults
Prediabetes is the term used to describe the condition where blood glucose level is higher than normal but lower than the diagnosis criteria of type 2 diabetes mellitus (T2DM). This condition confers a high risk for the development of T2DM and other diseases. Prediabetes could be reversible with lifestyle modifications, which include medical-nutrition therapy. Within these modifications, a healthy diet high in fiber and sources of alpha-linolenic acid is recommended. Flaxseed is a seed that is considered a functional food because it can provide health benefits due to its high content of fiber, alpha-linolenic acid, and lignans, these components could improve glycemic control in prediabetes patients by different mechanisms. The purpose of this study is to assess the effect of flaxseed on glycemic control in prediabetic adults.
Read the detailed description
Prediabetes is a condition that increases the risk of T2DM and other diseases, its prevalence increases year after year despite being a reversible condition through lifestyle changes, diet, and medication. Therefore, it is important to find new strategies that, together with the known treatments, help to improve glycemic control in people with prediabetes and thus their risk of developing TDM2. Among these strategies may be the consumption of flaxseed, one of the main sources of alpha-linolenic acid (ALA), an omega-3 fatty acid, lignans, and fiber.
This open-label randomized clinical trial will include, prior informed consent, 96 men and women with prediabetes, subjects will be allocated in two groups, the intervention group or the control group. The intervention group will receive 30 g per day of ground flaxseed dissolved in water, (15 g in the morning and 15 g in the night), they will also be provided with a dietary plan. The Control group will not receive any supplementation, only a dietary plan controlled in alpha-linolenic acid.
The intervention will last 12 weeks; during this time, all patients will be scheduled every 2 weeks for follow-up visits. During the follow-up visits, subjects will be evaluated for changes in gastrointestinal symptoms, and adherence to supplementation, which will be assessed by a daily record, and the return of empty or unopened bags of flaxseed.
Every month, all subjects will undergo anthropometric, clinical, dietary, and biochemical evaluations that include measurements of body weight, body composition, waist, and hip circumferences, blood pressure, physical activity, quality of food intake, dietary intake, fasting plasma glucose, hemoglobin A1C, insulin, LDL-C, HDL-C, triglycerides, and total cholesterol; an oral glucose tolerance test will be performed at baseline and the end of the study to each subject.
At the end of the study, the obtained information will be shared with the scientific community to provide a possible food-based strategy for prediabetic adults in addition to the already known prediabetes treatment. All participants of the study will be beneficiated with free nutritional, anthropometric, and biochemical assessments.
- Conditions
- Prediabetic State
- Being tested
- Flaxseed, Dietary plan
- Keywords
- Flax, Flaxseed, Linseed, Linum usitatissimum, Glycemic Control, Glycated Hemoglobin, Hemoglobin A1c, Glucose Tolerance Test, Blood glucose, Insulin resistance
- Medical subject headings
- Prediabetic State, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlaxseedOther
A total of 30 g of ground flaxseed per day divided into two portions of 15 grams each, subjects will be asked to take 15 g in the morning and 15 g in the night dissolved in 400 ml of water. They will receive a dietary plan with a distribution of 20-30% of protein, 25-30% of lipids, and 40 to 45% of carbohydrates.
Dietary planOther
Dietary plan with a distribution of 20-30% of protein, 25-30% of lipids, and 40 to 45% of carbohydrates, controlled consumption of alpha-linolenic acid (no more than 6.8 g/day, the amount provided by 30 g of flaxseed).
| Study group | Role | What they receive |
|---|---|---|
| Flaxseed and dietary plan | Experimental | 30 g of ground flaxseed daily and a dietary plan Receives: Other: Flaxseed |
| Control | Other | Dietary plan controlled in alpha-linolenic acid consumption Receives: Other: Dietary plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting plasma glucose
Changes in plasma glucose concentration after the intervention (mg/dL)
Measured: 12 weeks
2h-plasma glucose
Changes in 2h-plasma glucose concentration after an oral glucose tolerance test after the intervention (mg/dL)
Measured: 12 weeks
Hemoglobin A1C
Changes in hemoglobin A1C after the intervention (%)
Measured: 12 weeks
Secondary outcomes (11)
Insulin
Changes in insulin concentration after the intervention (mUI/L)
Measured: 12 weeks
Insulin resistance
Changes in insulin resistance after intervention assessed by the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), calculated using insulin and fasting plasma glucose concentrations
Measured: 12 weeks
Lipid profile
Changes in total cholesterol, HDL-C, LDL-C, and triglycerides concentrations after the intervention (mg/dL)
Measured: 12 weeks
Body Weight
Changes in body weight after the intervention (kg)
Measured: 12 weeks
Body composition
Changes in body fat and muscle percentage after the intervention (%)
Measured: 12 weeks
Waist and hip circumferences
Changes in waist and hip circumferences after the intervention (cm)
Measured: 12 weeks
Blood pressure
Changes in systolic and diastolic blood pressure after the intervention (mmHg)
Measured: 12 weeks
Physical activity level
Changes in total physical activity in METs-min/week assessed by the International Physical Activity Questionnaire - Short Form after the intervention
Measured: 12 weeks
Food intake quality
Changes in food intake quality after the intervention assessed by the Mini-Survey to Evaluate Food Intake Quality (Mini-ECCA v.2)
Measured: 12 weeks
Dietary ingestion
Changes in carbohydrate, protein, and fat ingestion after the intervention (g)
Measured: 12 weeks
Stool classification
Changes in stool consistency will be assessed with The Bristol Stool Form Scale (BSFS) after the intervention.
BSFS classifies stool into one of 7 stool types ranging from type 1 (hard lumps) to type 7 (watery), stool types 1 and 2 will be considered as constipation, stool types 5, 6, and 7 as diarrhea, and Stool types 3 and 4 as normal
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start20 Nov 2021
- Primary completion20 Feb 2024 (estimated)
- Study completion20 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prediabetic StateStudies 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
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Universitario de Ciencias de la Salud, Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriela Macedo Ojeda, Centro Universitario de Ciencias de la Salud, Mexico
- Investigators
- Gabriela Macedo Ojeda, PhD, Study director, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245825
- Sponsor's protocol ID
- CI-01721
- Acronym
- LINAPRED
- Status last verified
- Feb 2023
- First submitted
- 10 Jan 2022
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Flaxseed Supplementation on Glycemic Control in Prediabetic Adults
- ClinicalTrials.gov ID
- NCT05245825
- Acronym / sponsor ID
- LINAPRED / CI-01721
- Conditions
- Prediabetic State
- Keywords
- Flax, Flaxseed, Linseed, Linum usitatissimum, Glycemic Control, Glycated Hemoglobin, Hemoglobin A1c, Glucose Tolerance Test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Centro Universitario de Ciencias de la Salud, MexicoUniversity, hospital or other
- Study start
- 20 Nov 2021 (actual)
- Primary completion
- 20 Feb 2024 (estimated)
- Study completion
- 20 Feb 2024 (estimated)
- First posted
- 18 Feb 2022 (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.
Prediabetes is the term used to describe the condition where blood glucose level is higher than normal but lower than the diagnosis criteria of type 2 diabetes mellitus (T2DM). This condition confers a high risk for the development of T2DM and other diseases. Prediabetes could be reversible with lifestyle modifications, which include medical-nutrition therapy. Within these modifications, a healthy diet high in fiber and sources of alpha-linolenic acid is recommended. Flaxseed is a seed that is considered a functional food because it can provide health benefits due to its high content of fiber, alpha-linolenic acid, and lignans, these components could improve glycemic control in prediabetes patients by different mechanisms. The purpose of this study is to assess the effect of flaxseed on glycemic control in prediabetic adults.
Detailed description
Prediabetes is a condition that increases the risk of T2DM and other diseases, its prevalence increases year after year despite being a reversible condition through lifestyle changes, diet, and medication. Therefore, it is important to find new strategies that, together with the known treatments, help to improve glycemic control in people with prediabetes and thus their risk of developing TDM2. Among these strategies may be the consumption of flaxseed, one of the main sources of alpha-linolenic acid (ALA), an omega-3 fatty acid, lignans, and fiber.
This open-label randomized clinical trial will include, prior informed consent, 96 men and women with prediabetes, subjects will be allocated in two groups, the intervention group or the control group. The intervention group will receive 30 g per day of ground flaxseed dissolved in water, (15 g in the morning and 15 g in the night), they will also be provided with a dietary plan. The Control group will not receive any supplementation, only a dietary plan controlled in alpha-linolenic acid.
The intervention will last 12 weeks; during this time, all patients will be scheduled every 2 weeks for follow-up visits. During the follow-up visits, subjects will be evaluated for changes in gastrointestinal symptoms, and adherence to supplementation, which will be assessed by a daily record, and the return of empty or unopened bags of flaxseed.
Every month, all subjects will undergo anthropometric, clinical, dietary, and biochemical evaluations that include measurements of body weight, body composition, waist, and hip circumferences, blood pressure, physical activity, quality of food intake, dietary intake, fasting plasma glucose, hemoglobin A1C, insulin, LDL-C, HDL-C, triglycerides, and total cholesterol; an oral glucose tolerance test will be performed at baseline and the end of the study to each subject.
At the end of the study, the obtained information will be shared with the scientific community to provide a possible food-based strategy for prediabetic adults in addition to the already known prediabetes treatment. All participants of the study will be beneficiated with free nutritional, anthropometric, and biochemical assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flaxseed and dietary plan | Experimental | Other: Flaxseed30 g of ground flaxseed daily and a dietary plan |
| Control | Other | Other: Dietary planDietary plan controlled in alpha-linolenic acid consumption |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients who agree to participate in the study once they have read and signed the informed consent
- Men and women
- Fasting glucose levels between 100 and 125 mg/dl
- Age 30-59 years
- Stable weight in the last 3 months (no more than 5% weight change)
Key exclusion criteria (7 listed)
- Fasting glucose <100 and >125 mg/dl
- Anemia
- Consumption of drugs that may modify glucose levels
- Consumption of flaxseed, chia, or omega-3, three months before the study
- Alternative diets (vegetarian, vegan, ketogenic, etc.)
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 |
|---|---|---|
| FlaxseedA total of 30 g of ground flaxseed per day divided into two portions of 15 grams each, subjects will be asked to take 15 g in the morning and 15 g in the night dissolved in 400 ml of water. They will receive a dietary plan with a distribution of 20-30% of protein, 25-30% of lipids, and 40 to 45% of carbohydrates. | Other | Flaxseed and dietary plan |
| Dietary planDietary plan with a distribution of 20-30% of protein, 25-30% of lipids, and 40 to 45% of carbohydrates, controlled consumption of alpha-linolenic acid (no more than 6.8 g/day, the amount provided by 30 g of flaxseed). | Other | Control |
Primary outcome
Fasting plasma glucose
Time frame: 12 weeks
Changes in plasma glucose concentration after the intervention (mg/dL)
2h-plasma glucose
Time frame: 12 weeks
Changes in 2h-plasma glucose concentration after an oral glucose tolerance test after the intervention (mg/dL)
Hemoglobin A1C
Time frame: 12 weeks
Changes in hemoglobin A1C after the intervention (%)
11 secondary outcomes
Insulin
Time frame: 12 weeks
Insulin resistance
Time frame: 12 weeks
Lipid profile
Time frame: 12 weeks
Body Weight
Time frame: 12 weeks
Body composition
Time frame: 12 weeks
Waist and hip circumferences
Time frame: 12 weeks
Blood pressure
Time frame: 12 weeks
Physical activity level
Time frame: 12 weeks
Food intake quality
Time frame: 12 weeks
Dietary ingestion
Time frame: 12 weeks
Stool classification
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
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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. This study is not recruiting at the moment.
Gabriela Macedo Ojeda, PhD study director
University of Guadalajara
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 and Dietary plan in people with Prediabetic State, run by Centro Universitario de Ciencias de la Salud, Mexico 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 9 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabriela Macedo, PhD (+523310585200 ext. 33900, gabriela.macedo@cucs.udg.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting plasma glucose (time frame: 12 weeks). The study lists 3 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 9 Feb 2023.