Glycaemic Response of Arabic Bread
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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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:
- Pre-visit fast: Participants will fast for at least 10 hours before each visit.
- 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.
- Appetite assessment: Participants will complete visual analogue scale questionnaires at baseline and at set intervals throughout each visit to assess subjective appetite responses.
- Sensory evaluation: Participants will be asked to rate the sensory acceptability of each bread sample using a 9-point hedonic scale immediately after consumption.
- 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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Wejdan Shamakhay, Phd Student
- Telefonnummer: +44
- E-post: alyws7@nottingham.ac.uk
Studer Kontakt Backup
- Navn: Simon Welham, Associate Professor
- E-post: simon.welham@nottingham.ac.uk
Studiesteder
-
-
-
Nottingham, Storbritannia
- School of Biosciences, University of Nottingham, Sutton Bonington Campus, United Kingdom
-
Ta kontakt med:
- Simon Welham, Associate Professor
- Telefonnummer: 0115 951 6129
- E-post: simon.welham@nottingham.ac.uk
-
Ta kontakt med:
- Wejdan Shamakhay, PhD Student
- E-post: alyws7@nottingham.ac.uk
-
Hovedetterforsker:
- Wejdan Shamakhay, PhD student
-
Hovedetterforsker:
- Simon Welham, Associate Professor
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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) |
|
Eksperimentell: 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) |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Postprandial Blood Glucose Response
Tidsramme: 120 minutes
|
Differences in the iAUC for capillary blood glucose will be compared between bread formulations.
|
120 minutes
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
24 timers matinntak
Tidsramme: 24 timer
|
Totalt energiinntak, inntak av makronæringsstoffer til midnatt etter produktforbruk.
|
24 timer
|
|
Peak Postprandial Capillary Blood Glucose
Tidsramme: 120 minutes
|
Differences in the peak capillary blood glucose value after consuming each bread formulation.
|
120 minutes
|
|
Appetite Response
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Gastrointestinal Symptoms
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- FMHS 238-0925
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .