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| Name | Class |
|---|---|
| Norfolk and Norwich University Hospitals NHS Foundation Trust | OTHER |
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This study evaluates if the consumption of one sbeIIa/b white bread with high resistant starch content will result in a lower blood glucose response and increased satiety compared with reference white bread. All participants will be asked to consume once the sbeIIa/b white bread and the reference white bread during different visits.
In an attempt to increase dietary fibre intake, research has focused on developing wheat-based food products with novel fibres and starches to complement fibre intake from whole grain foods. Resistant starch is starch that escapes digestion in the small intestine and may be fermented in the large intestine by the microbiota. Resistant starch is a type of dietary fibre and it is normally found in wheat-based foods made from refined flour but only in small amounts. White bread made from sbeIIa/b wheat, which has high levels of resistant starch (a type of fibre), is showing promise in modulating blood glucose response and increasing satiety compared with conventional white bread.
The primary aim of this study is to determine whether consumption of sbeIIa/b white bread at breakfast, gives rise to a lower postprandial blood glucose response compared with consumption of a reference white bread in healthy individuals.
Additional aims of the study include: determining whether consumption of sbeIIa/b white bread by healthy subjects, gives rise to a lower glucose concentration in interstitial fluid, as measured by a Continuous Glucose Monitoring system (CGM), compared with consumption of control white bread; and exploring satiety and energy intake changes in healthy individuals following consumption of sbeIIa/b white bread at breakfast, compared with consumption of control white bread.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sbeIIa/b white bread | Experimental | sbeIIa/b white bread with high resistant starch content |
|
| Control white bread | Active Comparator | Reference white bread (wild-type) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sbeIIa/b white bread | Other | one bread roll containing approximately 75 g of available carbohydrates to be consumed at breakfast |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in postprandial capillary glucose concentration | Glucose concentration in capillary blood measured by finger prick test after the consumption of sbeIIa/b white bread compared to control white bread. Measurements will be taken during intervention visit 1 and 2 at -15, -10, -5, 15, 30, 45, 60, 75, 90, 120, 150, 180, 210 min. | 3.5 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in postprandial glucose concentration in interstitial fluid | Glucose concentration in interstitial fluid measured by continuous glucose monitoring system after the consumption of sbeIIa/b white bread compared to control white bread. Measurements will be taken during intervention visit 1 and 2 between -30 to 210 min. | 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marina Corrado, MSc | PhD student | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quadram Institute | Norwich | Norfolk | NR4 7UQ | United Kingdom |
De-identified individual participant data for primary and secondary outcome measures will be made available
Data will be available after publication in scientific journal within 18 months of study completion
Data access will be reviewed by the study team
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Double-blind randomised crossover study
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| Control white bread | Other | one bread roll containing approximately 75 g of available carbohydrates to be consumed at breakfast |
|
| Ad libitum intake |
Mean energy intake (kcal) at lunch after consumption of sbeIIa/b and control white bread. Measurements will be taken once during intervention visit 1 and 2. |
| 2 hours |
| Change in postprandial glucose concentration in interstitial fluid | Glucose concentration in interstitial fluid measured by continuous glucose monitoring system after the consumption of ad libitum lunch to explore any second meal effects caused by prior intake of either sbeIIa/b white bread and control white bread at breakfast. Measurements will be taken during intervention visit 1 and 2 between 225 to 465 min. | 4 hours |
| Satiety | Change of hunger feeling (appetite) will be examined using visual analog scale (0-10), 0 least and 10 greatest. Measurements will be taken during intervention visit 1 and 2, at 0, 32, 92, 182 min. | 3 hours |
| Sensory questionnaire | Sensory perception of sbeIIa/b white bread and control white bread will be evaluated using a nine-point hedonic scale to determine any differences overall acceptability based on specific attributes. A Just-About-Right (JAR) scale with five anchor points will be used to measure the appropriateness of the level of specific attributes to evaluate aroma, appearance, taste and texture of breads. Measurements will be taken once during intervention visit 1 and 2. | 30 minutes |