Flaxseed Supplementation in Prediabetic Adults (LINAPRED)
NCT ID: NCT05245825
Last Updated: 2023-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
96 participants
INTERVENTIONAL
2021-11-20
2024-02-20
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Flaxseed and dietary plan
30 g of ground flaxseed daily and a dietary plan
Flaxseed
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.
Control
Dietary plan controlled in alpha-linolenic acid consumption
Dietary plan
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).
Interventions
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Flaxseed
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 plan
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).
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
30 Years
59 Years
ALL
No
Sponsors
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Centro Universitario de Ciencias de la Salud, Mexico
OTHER
Responsible Party
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Gabriela Macedo Ojeda
Professor researcher A
Principal Investigators
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Gabriela Macedo Ojeda, PhD
Role: STUDY_DIRECTOR
University of Guadalajara
Locations
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Universidad de Guadalajara (CUCS)
Guadalajara, Jalisco, Mexico
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CI-01721
Identifier Type: -
Identifier Source: org_study_id
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