Flaxseed Supplementation in Prediabetic Adults (LINAPRED) (LINAPRED)

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.

Study Overview

• Status: Recruiting
• Conditions: Prediabetic State
• Intervention / Treatment: Other: Flaxseed; Other: Dietary plan

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 Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gabriela Macedo, PhD; Phone Number: 33900 +523310585200; Email: gabriela.macedo@cucs.udg.mx
• Study Contact Backup: Name: Yareni Zuñiga, PhD; Phone Number: 145 +523336190635; Email: lauray.zuniga@academicos.udg.mx

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44340
      • Recruiting
      • Universidad de Guadalajara (CUCS)
      • Contact: Gabriela Macedo, PhD; Phone Number: 33900 +523310585200; Email: gabriela.macedo@cucs.udg.mx
      • Contact: Yareni Zuñiga, PhD; Phone Number: 145 +523336190635; Email: lauray.zuniga@academicos.udg.mx

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 59 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Flaxseed and dietary plan; 30 g of ground flaxseed daily and a dietary plan	Other: 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.
OTHER: Control; Dietary plan controlled in alpha-linolenic acid consumption	Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting plasma glucose	Changes in plasma glucose concentration after the intervention (mg/dL)	12 weeks
2h-plasma glucose	Changes in 2h-plasma glucose concentration after an oral glucose tolerance test after the intervention (mg/dL)	12 weeks
Hemoglobin A1C	Changes in hemoglobin A1C after the intervention (%)	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin	Changes in insulin concentration after the intervention (mUI/L)	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	12 weeks
Lipid profile	Changes in total cholesterol, HDL-C, LDL-C, and triglycerides concentrations after the intervention (mg/dL)	12 weeks
Body Weight	Changes in body weight after the intervention (kg)	12 weeks
Body composition	Changes in body fat and muscle percentage after the intervention (%)	12 weeks
Waist and hip circumferences	Changes in waist and hip circumferences after the intervention (cm)	12 weeks
Blood pressure	Changes in systolic and diastolic blood pressure after the intervention (mmHg)	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	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)	12 weeks
Dietary ingestion	Changes in carbohydrate, protein, and fat ingestion after the intervention (g)	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	12 weeks

Collaborators and Investigators

• Sponsor: Centro Universitario de Ciencias de la Salud, Mexico
• Investigators: Study Director: Gabriela Macedo Ojeda, PhD, University of Guadalajara

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 20, 2021
• Primary Completion (ANTICIPATED): February 20, 2024
• Study Completion (ANTICIPATED): February 20, 2024

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (ACTUAL): February 18, 2022

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Insulin resistance; Blood glucose; Glucose Tolerance Test; Glycemic Control; Flaxseed; Hemoglobin A1c; Glycated Hemoglobin; Flax; Linseed; Linum usitatissimum
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: CI-01721

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No