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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06912542
Acronym
DM2
Enrollment
16
Registered
2025-04-04
Start date
2023-05-08
Completion date
2023-12-21
Last updated
2025-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Type 2, Insulin Resistance

Keywords

Postprandial Period, Glycemic Control, Flax, Bread

Brief 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.

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%.

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).

Sponsors

Universidade Franciscana (UFN)- Brasil
CollaboratorUNKNOWN
Universidade Francisca
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Randomized, crossover clinical study.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* The

Design outcomes

Primary

MeasureTime frameDescription
Capillary blood glucose concentrationIn 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

MeasureTime frameDescription
Insulin ConcentrationIn 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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026