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Completed

NCT Number: NCT06912542

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Franciscana

Santa Maria, Rio Grande do Sul, 97010032, Brazil

About this study

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:

  • Is flaxseed able to control the blood glucose levels of people with type 2 diabetes?
  • 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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Whole flaxseed bread

Other

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

Ground flaxseed bread

Other

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

French bread

Other

Plain French bread (control).

Primary outcomes

  1. Capillary blood glucose concentration

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

    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.

Secondary outcomes

  1. Insulin Concentration

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

    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.

Sponsors and collaborators

Lead sponsor

Universidade Francisca

Other

Collaborators

  • Universidade Franciscana (UFN)- Brasil

Registry information

Official study title

GLYCEMIC RESPONSE AFTER CONSUMPTION OF FRENCH BREAD WITH WHOLE OR GROUND FLAXSEEDS IN PEOPLE WITH TYPE 2 DIABETES MELLITUS

Acronym: DM2

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 4, 2025
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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