Clinical trial NCT06912542: ACUTE EFFECT OF CONSUMPTION OF GROUND OR WHOLE FLAXSEEDS ON BLOOD GLUCOSE IN PEOPLE WITH TYPE 2 DIABETES
Official title: GLYCEMIC RESPONSE AFTER CONSUMPTION OF FRENCH BREAD WITH WHOLE OR GROUND FLAXSEEDS IN PEOPLE WITH TYPE 2 DIABETES MELLITUS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Diabetes Type 2
Insulin Resistance
Keywords: Postprandial Period
Glycemic Control
Flax
Bread
Lead sponsor: Universidade Francisca
Sponsor class: OTHER
Collaborators: name: Universidade Franciscana (UFN)- Brasil
First posted: 2025-04-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, crossover clinical study.
Primary purpose: TREATMENT

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%.

Eligibility criteria: 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.

Primary outcomes:
measure: Capillary blood glucose concentration
timeFrame: In the 3 interventions, completed in 3 weeks.
Secondary outcomes:
measure: Insulin Concentration
timeFrame: In the 3 interventions, completed in 3 weeks.
Other outcomes:
Locations:
city: Santa Maria
country: Brazil
facility: Universidade Franciscana
state: RS
Study officials:
affiliation: Universidade Franciscana
name: Laureana de Quevedo Barcelos, Mestre
role: PRINCIPAL_INVESTIGATOR
References: