Clinical trial NCT05245825: Flaxseed Supplementation in Prediabetic Adults (LINAPRED)
Official title: Effect of Flaxseed Supplementation on Glycemic Control in Prediabetic Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prediabetic State
Keywords: Flax
Flaxseed
Linseed
Linum usitatissimum
Glycemic Control
Glycated Hemoglobin
Hemoglobin A1c
Glucose Tolerance Test
Blood glucose
Insulin resistance
Lead sponsor: Centro Universitario de Ciencias de la Salud, Mexico
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 96
Sex: ALL
Minimum age (years): 30
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Fasting plasma glucose
timeFrame: 12 weeks
measure: 2h-plasma glucose
timeFrame: 12 weeks
measure: Hemoglobin A1C
timeFrame: 12 weeks
Secondary outcomes:
measure: Insulin
timeFrame: 12 weeks
measure: Insulin resistance
timeFrame: 12 weeks
measure: Lipid profile
timeFrame: 12 weeks
measure: Body Weight
timeFrame: 12 weeks
measure: Body composition
timeFrame: 12 weeks
measure: Waist and hip circumferences
timeFrame: 12 weeks
measure: Blood pressure
timeFrame: 12 weeks
measure: Physical activity level
timeFrame: 12 weeks
measure: Food intake quality
timeFrame: 12 weeks
measure: Dietary ingestion
timeFrame: 12 weeks
measure: Stool classification
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Universidad de Guadalajara (CUCS)
state: Jalisco
Study officials:
affiliation: University of Guadalajara
name: Gabriela Macedo Ojeda, PhD
role: STUDY_DIRECTOR
References: