NCT05245825

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2024

Completed
Last Updated

February 9, 2023

Status Verified

February 1, 2023

Enrollment Period

2.3 years

First QC Date

January 10, 2022

Last Update Submit

February 7, 2023

Conditions

Prediabetic State

Keywords

FlaxFlaxseedLinseedLinum usitatissimumGlycemic ControlGlycated HemoglobinHemoglobin A1cGlucose Tolerance TestBlood glucoseInsulin resistance

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (11)

  • Insulin

    12 weeks

  • Insulin resistance

    12 weeks

  • Lipid profile

    12 weeks

  • Body Weight

    12 weeks

  • Body composition

    12 weeks

  • +6 more secondary outcomes

Study Arms (2)

Flaxseed and dietary plan

EXPERIMENTAL

30 g of ground flaxseed daily and a dietary plan

Other: Flaxseed

Control

OTHER

Dietary plan controlled in alpha-linolenic acid consumption

Other: Dietary plan

Interventions

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.

Flaxseed and dietary plan
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).

Control

Eligibility Criteria

Age30 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Guadalajara (CUCS)

Guadalajara, Jalisco, 44340, Mexico

RECRUITING

MeSH Terms

Conditions

Prediabetic StateInsulin Resistance

Interventions

Linseed Oil

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

Fats, UnsaturatedFatsLipidsPlant OilsOilsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Gabriela Macedo Ojeda, PhD

    University of Guadalajara

    STUDY DIRECTOR

Central Study Contacts

Gabriela Macedo, PhD

CONTACT

+523310585200gabriela.macedo@cucs.udg.mx

Yareni Zuñiga, PhD

CONTACT

+523336190635lauray.zuniga@academicos.udg.mx

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor researcher A

Study Record Dates

First Submitted

January 10, 2022

First Posted

February 18, 2022

Study Start

November 20, 2021

Primary Completion

February 20, 2024

Study Completion

February 20, 2024

Last Updated

February 9, 2023

Record last verified: 2023-02

Locations

ME(1)