Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Glycaemic Response of Arabic Bread

10 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

14

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Regno Unito
      • Nottingham, Regno Unito
        • School of Biosciences, University of Nottingham, Sutton Bonington Campus, United Kingdom
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Wejdan Shamakhay, PhD student
        • Investigatore principale:
          • Simon Welham, Associate Professor

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: Control Bread
Arabic bread prepared with 100% wheat flour, providing an equivalent of 50g of available carbohydrate.
Altro: Chickpea-Enriched Arabic Bread

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

(This is the primary experimental comparison)

Altro: Pea-Enriched Arabic Bread

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

(Optional secondary comparison)

Altro: Lentil-Enriched Arabic Bread

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

(Optional secondary comparison)
Sperimentale: 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.
Altro: Control Bread
Arabic bread prepared with 100% wheat flour, providing an equivalent of 50g of available carbohydrate.
Altro: Chickpea-Enriched Arabic Bread

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

(This is the primary experimental comparison)

Altro: Pea-Enriched Arabic Bread

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

(Optional secondary comparison)

Altro: Lentil-Enriched Arabic Bread

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

(Optional secondary comparison)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Postprandial Blood Glucose Response
Lasso di tempo: 120 minutes
Differences in the iAUC for capillary blood glucose will be compared between bread formulations.
120 minutes

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Assunzione di cibo nelle 24 ore
Lasso di tempo: 24 ore
Apporto energetico totale, apporto di macronutrienti fino a mezzanotte dopo il consumo del prodotto.
24 ore
Peak Postprandial Capillary Blood Glucose
Lasso di tempo: 120 minutes
Differences in the peak capillary blood glucose value after consuming each bread formulation.
120 minutes
Appetite Response
Lasso di tempo: 120 minutes
Appetite sensations including hunger, fullness, and desire to eat assessed using visual analogue scales (VAS) at baseline and at regular intervals throughout each visit.
120 minutes
Sensory Acceptability
Lasso di tempo: Immediately after consumption
Overall liking and sensory acceptability of each Arabic bread sample were assessed using the 9-point hedonic scale immediately after consumption.
Immediately after consumption

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Gastrointestinal Symptoms
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Nottingham

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

31 marzo 2027

Completamento dello studio (Stimato)

31 marzo 2027

Date di iscrizione allo studio

Primo inviato

10 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

10 giugno 2026

Primo Inserito (Effettivo)

17 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 giugno 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • FMHS 238-0925

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Control Bread

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Cameroon

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi