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

NCT ID: NCT06912542

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-08
• Study Completion Date: 2023-12-21

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%.

Conditions

Diabetes; Diabetes Type 2; Insulin Resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Whole flaxseed bread

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

Group Type: ACTIVE_COMPARATOR

Whole flaxseed bread

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Ground flaxseed bread

Intervention Type: OTHER

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

Control bread

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

Group Type: PLACEBO_COMPARATOR

French bread

Intervention Type: OTHER

Plain French bread (control).

Interventions

Whole flaxseed bread

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

Intervention Type: OTHER

Ground flaxseed bread

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

Intervention Type: OTHER

French bread

Plain French bread (control).

Intervention Type: OTHER

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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Franciscana (UFN)- Brasil

UNKNOWN

Sponsor Role: collaborator

Universidade Francisca

OTHER

Sponsor Role: lead

Responsible Party

Laureana Q Barcelos

Mestre em Ciências da Saúde e da Vida

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laureana de Quevedo Barcelos, Mestre

Role: PRINCIPAL_INVESTIGATOR

Universidade Franciscana

Locations

Universidade Franciscana

Santa Maria, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

64777622.00000.5306

Identifier Type: REGISTRY

Identifier Source: secondary_id

Research Ethics Committee

Identifier Type: REGISTRY

Identifier Source: secondary_id

5.747.049

Identifier Type: -

Identifier Source: org_study_id