ACUTE EFFECT OF CONSUMPTION OF GROUND OR WHOLE FLAXSEEDS ON BLOOD GLUCOSE IN PEOPLE WITH TYPE 2 DIABETES (DM2)
March 31, 2025 updated by: Laureana Q Barcelos, Universidade Francisca
GLYCEMIC RESPONSE AFTER CONSUMPTION OF FRENCH BREAD WITH WHOLE OR GROUND FLAXSEEDS IN PEOPLE WITH TYPE 2 DIABETES MELLITUS
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:
- Is flaxseed able to control the glycemia of people with type 2 diabetes?
- 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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:
- 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%.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
RS
-
Santa Maria, RS, Brazil, 97010032
- Universidade Franciscana
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Whole flaxseed bread
The 16 participants consumed 1 serving of bread with 30 g of whole flaxseeds in one of the three study interventions.
|
French bread with the addition of 30g of whole flaxseed.
|
|
Active Comparator: 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.
|
French bread with the addition of 30g of ground flaxseed.
|
|
Placebo Comparator: Control bread
The 16 participants consumed 1 serving of control bread (without flaxseeds) in one of the three study interventions.
|
Plain French bread (control).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
In the 3 interventions, completed in 3 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
In the 3 interventions, completed in 3 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Laureana de Quevedo Barcelos, Mestre, Universidade Franciscana
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 8, 2023
Primary Completion (Actual)
December 21, 2023
Study Completion (Actual)
December 21, 2023
Study Registration Dates
First Submitted
March 10, 2025
First Submitted That Met QC Criteria
March 31, 2025
First Posted (Actual)
April 4, 2025
Study Record Updates
Last Update Posted (Actual)
April 4, 2025
Last Update Submitted That Met QC Criteria
March 31, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5.747.049
- Research Ethics Committee (Other Identifier: The Research Ethics Committee of the College of Dentistry, University of Baghdad. Project No. 1026125)
- 64777622.00000.5306 (Registry Identifier: CAAE - Certificate of Presentation of Ethical Appreciation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Protocolo de estudo
IPD Sharing Time Frame
Starting 1 year after publication with no end date.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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