ACUTE EFFECT OF CONSUMPTION OF GROUND OR WHOLE FLAXSEEDS ON BLOOD GLUCOSE IN PEOPLE WITH TYPE 2 DIABETES (DM2)

Universidade Francisca

Status: Completed

Conditions: Diabetes; Insulin Resistance; Diabetes Type 2

Treatments: Other: Ground flaxseed bread; Other: Whole flaxseed bread; Other: French bread

Study type: Interventional

Funder types: Other

Identifiers

NCT06912542

Research Ethics Committee (Registry Identifier)

5.747.049

64777622.00000.5306 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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%.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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16 participants in 3 patient groups, including a placebo group

Whole flaxseed bread

Active Comparator group

Description:

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

Treatment:

Other: Whole flaxseed bread

Bread with ground flaxseed

Active Comparator group

Description:

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

Treatment:

Other: Ground flaxseed bread

Control bread

Placebo Comparator group

Description:

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

Treatment:

Other: French bread