Glycaemic Response to Arabic Bread Formulated With Alternative Flour Blends: A Comparison With Arabic Wheat Bread
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 14
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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:
- Control bread (100% wheat flour)
- Arabic bread containing 30% chickpea flour, with 70% wheat flour (primary comparison with control)
- Arabic bread containing 30% pea flour, with 70% wheat flour(optional secondary comparison with control)
- Arabic bread containing 30% lentil flour, with 70% wheat flour (optional secondary comparison with control)
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
Participants will be masked to the type of bread they are consuming at each visit.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants will be adults living with overweight or obesity (Body Mass Index [BMI] > 25 kg/m²).
- •Participants will be of any gender.
- •Participants will be aged 18 to
- •Participants will be from any sociodemographic background.
- •Participants will be able to provide informed consent.
- •Participants will be able to understand spoken and written English and be able to record their responses to questionnaires.
排除标准
- •Those with food allergies or intolerances to any of the study ingredients, including wheat, chickpeas, lentils, or peas, will not be eligible.
- •Individuals with a known diagnosis of metabolic or chronic health conditions, such as diabetes, insulin resistance, hypertension, or phenylketonuria, will be excluded due to the potential impact on glycaemic control and study outcomes.
- •Participants with a fasting blood glucose level of above 7.0 mmol/L.
- •Use of medications that influence blood glucose levels (e.g., corticosteroids, antipsychotics, antiviral protease inhibitors) or substances that interfere with digestion and absorption (such as laxatives or fibre supplements) will result in exclusion.
- •Pregnant or breastfeeding individuals will not be included due to the physiological changes that may influence study outcomes.
- •Participants with implanted medical devices, including pacemakers, artificial organs, defibrillators, or joint replacements, will be excluded for safety considerations.
- •Anyone who has undergone major surgery or hospitalisation within the last 5 months will be deemed ineligible.
- •Individuals who have participated in another research study involving invasive procedures within the last 3 months will be excluded.
研究组 & 干预措施
Control bread followed by chickpea bread
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.
干预措施: Control Bread (Other)
Control bread followed by chickpea bread
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.
干预措施: Chickpea-Enriched Arabic Bread (Other)
Control bread followed by chickpea bread
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.
干预措施: Pea-Enriched Arabic Bread (Other)
Control bread followed by chickpea bread
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.
干预措施: Lentil-Enriched Arabic Bread (Other)
Chickpea bread followed by control bread
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.
干预措施: Control Bread (Other)
Chickpea bread followed by control bread
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.
干预措施: Chickpea-Enriched Arabic Bread (Other)
Chickpea bread followed by control bread
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.
干预措施: Pea-Enriched Arabic Bread (Other)
Chickpea bread followed by control bread
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.
干预措施: Lentil-Enriched Arabic Bread (Other)
结局指标
主要结局
未指定
次要结局
- Appetite Response(120 minutes)
- Sensory Acceptability(Immediately after consumption)
研究者
Wejdan Shamakhay
Principal Investigator
University of Nottingham