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| ID | Type | Description | Link |
|---|---|---|---|
| 64777622.00000.5306 | Registry Identifier | CAAE - Certificate of Presentation of Ethical Appreciation | |
| Research Ethics Committee | Registry Identifier | 5.747.049 |
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| Name | Class |
|---|---|
| Universidade Franciscana (UFN)- Brasil | UNKNOWN |
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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:
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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Control bread | Placebo Comparator | The 16 participants consumed 1 serving of control bread (without flaxseeds) in one of the three study interventions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole flaxseed bread | Other | French bread with the addition of 30g of whole flaxseed. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | In the 3 interventions, completed in 3 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | In the 3 interventions, completed in 3 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laureana de Quevedo Barcelos, Mestre | Universidade Franciscana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Franciscana | Santa Maria | Rio Grande do Sul | 97010032 | Brazil |
Protocolo de estudo
Starting 1 year after publication with no end date.
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Randomized, crossover clinical study.
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| Ground flaxseed bread | Other | French bread with the addition of 30g of ground flaxseed. |
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| French bread | Other | Plain French bread (control). |
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| D006946 | Hyperinsulinism |