CClinicalTrials.gg
CompletedNCT06912542DM2Updated Apr 4, 2025

ACUTE EFFECT OF CONSUMPTION OF GROUND OR WHOLE FLAXSEEDS ON BLOOD GLUCOSE IN PEOPLE WITH TYPE 2 DIABETES

An interventional study of Whole flaxseed bread and Ground flaxseed bread in Diabetes, Diabetes Type 2 and Insulin Resistance, sponsored by Universidade Francisca. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-04.

Sponsored by Universidade Francisca · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled May 2023, registered Mar 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study aimed to evaluate the effect of consuming a portion of French bread combined with whole or ground flaxseed on the glycemia of people with DM 2 in a randomized, crossover clinical trial conducted with 16 people with DM 2 who were not using insulin.

The main questions of the study were:

  1. Is flaxseed able to control the glycemia of people with type 2 diabetes?
  2. What is the best way to consume flaxseed to control the glycemia of people with type 2 diabetes?

The 3 types of bread (whole flaxseed, ground flaxseed and control) were evaluated in interventions, with a 7-day interval between them, for the consumption of the bread and evaluation of the behavior of the glycemia and insulin curve.

Read the detailed description

This study aimed to evaluate the effect of consuming a portion of French bread combined with whole or ground flaxseed on the blood glucose levels of people with DM 2 in a randomized, crossover clinical trial conducted with 16 people with DM 2 who were not taking insulin.

The main questions of the study were:

  1. Is flaxseed able to control the blood glucose levels of people with type 2 diabetes?
  2. What is the best way to consume flaxseed to control the blood glucose levels of people with type 2 diabetes? People with type 2 diabetes mellitus participated in the study, divided into three groups for random consumption of the breads: French bread without flaxseed (control bread), French bread with 30g of whole flaxseed, and French bread with 30g of ground flaxseed. The design was crossover and had a 7-day washout. Capillary blood glucose levels were monitored during fasting and at 15, 30, 60, 90 and 120 minutes after ingestion of the breads, while serum glucose and insulin levels were measured during fasting and at peak blood glucose levels, at 60 minutes. In addition, sociodemographic and clinical data (medication use, duration of DM2, bowel habits, sleep, and physical activity), nutritional status, and pre-intervention food consumption with a 24-hour dietary recall were evaluated. The data were analyzed in the R statistical software, through the Shapiro-Wilk normality test, one-way ANOVA, with Tukey or Kruskal-Wallis post-hoc. The analyses had a significance level of 5%.
02

Conditions studied

  • Diabetes
  • Diabetes Type 2
  • Insulin Resistance

Keywords

  • Postprandial Period
  • Glycemic Control
  • Flax
  • Bread
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 16 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

This is the only study on the registry with Universidade Francisca as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • The selection included individuals with DM 2
  • Of both sexes
  • Adults and elderly individuals without risk of dysphagia
  • Aged 18 years or older
  • Without allergies to the test foods
  • With the habit of having breakfast (≥4 days a week, with an intake of ≥100 kcal within two hours of waking up)
  • Availability of time for the days planned for the research.

Exclusion criteria

Exclusion Criteria:

  • The exclusion criteria were applied to individuals diagnosed with another type of Diabetes
  • Using exogenous insulin
  • Pregnant or lactating women
  • Smokers
  • With diseases that affect taste
  • The gastrointestinal system, and who reported the last intestinal frequency according to the Bristol scale 1, 2, 5, 6 and 7.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
16 participants (actual)

Study arms

  • Active comparator
    Whole flaxseed bread

    The 16 participants consumed 1 serving of bread with 30 g of whole flaxseeds in one of the three study interventions.

    Other: Whole flaxseed bread

  • Active comparator
    Bread with ground flaxseed

    The 16 participants consumed 1 serving of bread with 30 g of ground flaxseeds in one of the three study interventions.

    Other: Ground flaxseed bread

  • Placebo comparator
    Control bread

    The 16 participants consumed 1 serving of control bread (without flaxseeds) in one of the three study interventions.

    Other: French bread

Interventions

  • OtherWhole flaxseed bread

    French bread with the addition of 30g of whole flaxseed.

  • OtherGround flaxseed bread

    French bread with the addition of 30g of ground flaxseed.

  • OtherFrench bread

    Plain French bread (control).

06

What researchers measure

Primary outcomes

  1. Capillary blood glucose concentration

    Six capillary blood glucose tests were performed in each study intervention. Time 0 (zero) was the basal measurement, and the others were performed in the postprandial period at 15, 30, 90 and 120 minutes.

    Time frame: In the 3 interventions, completed in 3 weeks.

Secondary outcomes

  1. Insulin Concentration

    Two plasma insulin tests were performed in each study intervention. Time 0 (zero) was the basal measurement, and the other was at the peak of the postprandial period, considered at 60 minutes.

    Time frame: In the 3 interventions, completed in 3 weeks.

07

Study locations

1 site
  • Universidade Franciscana
    Santa Maria, RS 97010032, Brazil
08

References and documents

Individual participant data

Plan to share: Yes — Protocolo de estudo

Supporting information: Study protocol, Icf

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06912542
Lead sponsor
Universidade Francisca
Collaborators
Universidade Franciscana (UFN)- Brasil
Responsible party
Laureana Q Barcelos (Mestre em Ciências da Saúde e da Vida, Universidade Francisca) — Principal investigator
First posted
Apr 4, 2025
Start date
May 8, 2023
Primary completion
Dec 21, 2023
Completion
Dec 21, 2023
Last update
Apr 4, 2025

Study contacts

Laureana de Quevedo Barcelos, Mestre
principal investigator · Universidade Franciscana

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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