DiabetesDM2NCT06912542
ACUTE EFFECT OF CONSUMPTION OF GROUND OR WHOLE FLAXSEEDS ON BLOOD GLUCOSE IN PEOPLE WITH TYPE 2 DIABETES
A study testing Whole flaxseed bread, Ground flaxseed bread and French bread in people with Diabetes and Diabetes Type 2, run by Universidade Francisca at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Type 2, Insulin Resistance
- What is being tested?
- Whole flaxseed bread, Ground flaxseed bread and French bread
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteBrazil
- Study dates
- 8 May 2023to 21 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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%.
- Conditions
- Diabetes, Diabetes Type 2, Insulin Resistance
- Being tested
- Whole flaxseed bread, Ground flaxseed bread, French bread
- Keywords
- Postprandial Period, Glycemic Control, Flax, Bread
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole flaxseed breadOther
French bread with the addition of 30g of whole flaxseed.
Ground flaxseed breadOther
French bread with the addition of 30g of ground flaxseed.
French breadOther
Plain French bread (control).
| Study group | Role | What they receive |
|---|---|---|
| Whole flaxseed bread | Active comparator | The 16 participants consumed 1 serving of bread with 30 g of whole flaxseeds in one of the three study interventions. Receives: Other: Whole flaxseed bread |
| Bread with ground flaxseed | Active comparator | The 16 participants consumed 1 serving of bread with 30 g of ground flaxseeds in one of the three study interventions. Receives: Other: Ground flaxseed bread |
| Control bread | Placebo comparator | The 16 participants consumed 1 serving of control bread (without flaxseeds) in one of the three study interventions. Receives: Other: French bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capillary blood glucose concentration
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.
Measured: In the 3 interventions, completed in 3 weeks.
Secondary outcomes (1)
Insulin Concentration
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.
Measured: In the 3 interventions, completed in 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start8 May 2023
- Primary completion21 Dec 2023
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, crossover clinical study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Francisca
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Franciscana (UFN)- Brasil
- Responsible party
- Principal investigator, Laureana Q Barcelos, Universidade Francisca
- Investigators
- Laureana de Quevedo Barcelos, Mestre, Principal investigator, Universidade Franciscana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912542
- Sponsor's protocol ID
- 5.747.049
- Other IDs
- 64777622.00000.5306, Research Ethics Committee
- Acronym
- DM2
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Protocolo de estudo
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GLYCEMIC RESPONSE AFTER CONSUMPTION OF FRENCH BREAD WITH WHOLE OR GROUND FLAXSEEDS IN PEOPLE WITH TYPE 2 DIABETES MELLITUS
- ClinicalTrials.gov ID
- NCT06912542
- Acronym / sponsor ID
- DM2 / 5.747.049
- Conditions
- Diabetes, Diabetes Type 2, Insulin Resistance
- Keywords
- Postprandial Period, Glycemic Control, Flax, Bread
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Universidade FranciscaUniversity, hospital or other
- Collaborators
- Universidade Franciscana (UFN)- Brasil
- Study start
- 8 May 2023 (actual)
- Primary completion
- 21 Dec 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, crossover clinical study.
| Arm | Type | Receives |
|---|---|---|
| Whole flaxseed bread | Active comparator | Other: Whole flaxseed breadThe 16 participants consumed 1 serving of bread with 30 g of whole flaxseeds in one of the three study interventions. |
| Bread with ground flaxseed | Active comparator | Other: Ground flaxseed breadThe 16 participants consumed 1 serving of bread with 30 g of ground flaxseeds in one of the three study interventions. |
| Control bread | Placebo comparator | Other: French breadThe 16 participants consumed 1 serving of control bread (without flaxseeds) in one of the three study interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole flaxseed breadFrench bread with the addition of 30g of whole flaxseed. | Other | Whole flaxseed bread |
| Ground flaxseed breadFrench bread with the addition of 30g of ground flaxseed. | Other | Bread with ground flaxseed |
| French breadPlain French bread (control). | Other | Control bread |
Primary outcome
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.
1 secondary outcome
Insulin Concentration
Time frame: In the 3 interventions, completed in 3 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: Yes. Protocolo de estudo
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laureana de Quevedo Barcelos, Mestre principal investigator
Universidade Franciscana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole flaxseed bread, Ground flaxseed bread and French bread in people with Diabetes and Diabetes Type 2, run by Universidade Francisca at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Capillary blood glucose concentration (time frame: In the 3 interventions, completed in 3 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.