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Bread remains one of the most widely consumed staple foods worldwide, with wheat flour serving as its traditional foundation. However, the widespread dependence on refined wheat-based bread has paralleled the rising prevalence of type 2 diabetes (T2D), partly owing to its high glycaemic index (GI), which results in rapid increases in blood glucose levels. Enhancing the nutritional quality of bread, therefore, represents an important target for dietary intervention.
Developing alternative flour blends for bread production presents a potential strategy for improving glycaemic control and supporting glucose homeostasis. Accordingly, this clinical trial aims to determine whether the partial replacement of wheat flour with legume flours, including chickpea, pea, and lentil, in Arabic bread formulations can lower glycaemic responses compared with traditional Arabic wheat bread.
This study will be a crossover trial. Participants living with overweight and obesity will be recruited and fully informed about the study before giving informed consent. Eligible participants will attend the University of Nottingham on 4 separate visits following an overnight fast of at least 10 hours. On each visit, participants will consume one of three Arabic bread formulations or a control, with a one-week washout between visits. Each bread sample will provide an equivalent of 50 g of available carbohydrate:
The primary focus of this study is the comparison between the control bread and the chickpea-enriched bread, as chickpea flour represents the main intervention. The pea-enriched bread and lentil-enriched variants are included as optional secondary comparisons to provide additional insights into the broader effect of legume flour substitution on glycaemic response.
Study Visits:
The procedures for each visit are summarised below:
Gastrointestinal symptoms will also be monitored via a brief self-reported questionnaire at baseline and post-consumption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control bread followed by chickpea bread | Experimental | Participants will consume control Arabic bread followed by chickpea-enriched Arabic bread after the one week's washout period. Participants who complete the primary crossover phase may optionally continue to pea and/or lentil bread interventions. |
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| Chickpea bread followed by control bread | Experimental | Participants will consume chickpea-enriched Arabic bread followed by control Arabic bread after one week the washout period. Participants who complete the primary crossover phase may optionally continue to additional exploratory bread interventions, including pea bread and/or lentil bread. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Bread | Other | Arabic bread prepared with 100% wheat flour, providing an equivalent of 50g of available carbohydrate. |
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| Measure | Description | Time Frame |
|---|---|---|
| Postprandial Blood Glucose Response | Differences in the iAUC for capillary blood glucose will be compared between bread formulations. | 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Postprandial Capillary Blood Glucose | Differences in the peak capillary blood glucose value after consuming each bread formulation. | 120 minutes |
| Appetite Response | Appetite sensations (hunger, fullness, desire to eat sweet foods, desire to eat salty foods, desire to eat fatty foods, and desire to eat savoury foods) will be assessed using a 100-mm Visual Analogue Scale (VAS). Scores range from 0 to 100 mm. Higher scores indicate greater intensity of the appetite sensation being measured (e.g., greater hunger, fullness, or desire to eat). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wejdan Shamakhay, Phd Student | Contact | +44 | alyws7@nottingham.ac.uk | |
| Simon Welham, Associate Professor | Contact | simon.welham@nottingham.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Biosciences, University of Nottingham, Sutton Bonington Campus, United Kingdom | Nottingham | United Kingdom |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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All enrolled participants will complete the primary crossover comparison between the control bread and the chickpea-enriched bread. Following completion of the primary study phase, participants will be invited to undertake two additional optional study visits involving pea-enriched and lentil-enriched Arabic bread. These exploratory comparisons will be conducted using the same participant cohort and are intended to provide supplementary data on the effects of alternative legume flour substitutions on postprandial glycaemic response.
(To allow for potential dropouts and missing data, we plan to recruit 14-20 participants)
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Participants will be masked to the type of bread they are consuming at each visit.
| Chickpea-Enriched Arabic Bread | Other | Arabic bread prepared with 30% chickpea flour and 70% wheat flour, providing an equivalent of 50g available carbohydrate. (This is the primary experimental comparison) |
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| Pea-Enriched Arabic Bread | Other | Arabic bread prepared with 30% pea flour and 70% wheat flour, providing an equivalent of 50g available carbohydrate. (Optional secondary comparison) |
|
| Lentil-Enriched Arabic Bread | Other | Arabic bread prepared with 30% lentil flour and 70% wheat flour, providing an equivalent of 50g available carbohydrate. (Optional secondary comparison) |
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| 120 minutes |
| Sensory Acceptability | Sensory acceptability of each Arabic bread sample will be assessed using a 9-Point Hedonic Scale. Scores range from 1 to 9, with higher scores indicating greater liking and sensory acceptability across sensory attributes, including overall liking, colour, aroma, flavour, texture, chewability, roundness, and crumb characteristics. | Immediately after consumption |
| 24 hour food intake | Total energy intake, macronutrient intake until midnight after product consumption. | 24 hours |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |