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Glycaemic Response of Arabic Bread

17 de junho de 2026 atualizado por: Wejdan Shamakhay, University of Nottingham

Glycaemic Response to Arabic Bread Formulated With Alternative Flour Blends: A Comparison With Arabic Wheat Bread

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.

Visão geral do estudo

Descrição detalhada

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:

  1. Control bread (100% wheat flour)
  2. Arabic bread containing 30% chickpea flour, with 70% wheat flour (primary comparison with control)
  3. Arabic bread containing 30% pea flour, with 70% wheat flour(optional secondary comparison with control)
  4. 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:

  1. Pre-visit fast: Participants will fast for at least 10 hours before each visit.
  2. Blood glucose sampling: Capillary blood glucose will be measured via finger prick at baseline and at regular intervals over 120 minutes following consumption (0, 15, 30, 60, 90, and 120 min) of the bread sample to assess the postprandial glycaemic response.
  3. Appetite assessment: Participants will complete visual analogue scale questionnaires at baseline and at set intervals throughout each visit to assess subjective appetite responses.
  4. Sensory evaluation: Participants will be asked to rate the sensory acceptability of each bread sample using a 9-point hedonic scale immediately after consumption.
  5. Dietary intake: Participants will complete 24-hour food diaries in each visit.

Gastrointestinal symptoms will also be monitored via a brief self-reported questionnaire at baseline and post-consumption.

Tipo de estudo

Intervencional

Inscrição (Estimado)

14

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

      • Nottingham, Reino Unido
        • School of Biosciences, University of Nottingham, Sutton Bonington Campus, United Kingdom
        • Contato:
        • Contato:
        • Investigador principal:
          • Wejdan Shamakhay, PhD student
        • Investigador principal:
          • Simon Welham, Associate Professor

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

Inclusion Criteria:

  • 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 65.
  • 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.

Exclusion Criteria:

  • 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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Ciência básica
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Arabic bread prepared with 100% wheat flour, providing an equivalent of 50g of available carbohydrate.

Arabic bread prepared with 30% chickpea flour and 70% wheat flour, providing an equivalent of 50g available carbohydrate.

(This is the primary experimental comparison)

Arabic bread prepared with 30% pea flour and 70% wheat flour, providing an equivalent of 50g available carbohydrate.

(Optional secondary comparison)

Arabic bread prepared with 30% lentil flour and 70% wheat flour, providing an equivalent of 50g available carbohydrate.

(Optional secondary comparison)

Experimental: 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.
Arabic bread prepared with 100% wheat flour, providing an equivalent of 50g of available carbohydrate.

Arabic bread prepared with 30% chickpea flour and 70% wheat flour, providing an equivalent of 50g available carbohydrate.

(This is the primary experimental comparison)

Arabic bread prepared with 30% pea flour and 70% wheat flour, providing an equivalent of 50g available carbohydrate.

(Optional secondary comparison)

Arabic bread prepared with 30% lentil flour and 70% wheat flour, providing an equivalent of 50g available carbohydrate.

(Optional secondary comparison)

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Postprandial Blood Glucose Response
Prazo: 120 minutes
Differences in the iAUC for capillary blood glucose will be compared between bread formulations.
120 minutes

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Ingestão alimentar 24 horas
Prazo: 24 horas
Ingestão total de energia, ingestão de macronutrientes até meia-noite após o consumo do produto.
24 horas
Peak Postprandial Capillary Blood Glucose
Prazo: 120 minutes
Differences in the peak capillary blood glucose value after consuming each bread formulation.
120 minutes
Appetite Response
Prazo: 120 minutes
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).
120 minutes
Sensory Acceptability
Prazo: Immediately after consumption
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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Gastrointestinal Symptoms
Prazo: At baseline (0 minute) and 120 minutes post-consumption
Participants will complete a brief self-reported gastrointestinal symptom questionnaire pre- and post-consumption to assess symptoms such as bloating, abdominal discomfort, and flatulence.
At baseline (0 minute) and 120 minutes post-consumption

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de junho de 2026

Conclusão Primária (Estimado)

31 de março de 2027

Conclusão do estudo (Estimado)

31 de março de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

10 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de junho de 2026

Primeira postagem (Real)

17 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de junho de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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