Glycaemic Response of Arabic Bread

NCT07652320 | Not Yet Recruiting

• 1 other identifier: FMHS 238-0925
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glycaemic Response in Overweight and/or Obesity

Keywords

Glycaemic Response; Arabic Bread; Legume Flour; Wheat Flour; Postprandial Glucose; Overweight; Obesity; Satiety; Appetite

Outcome Measures

Primary Outcomes (1)

• Postprandial Blood Glucose Response

  Differences in the iAUC for capillary blood glucose will be compared between bread formulations.

  120 minutes

Secondary Outcomes (4)

• Peak Postprandial Capillary Blood Glucose

  120 minutes

• Appetite Response

  120 minutes

• Sensory Acceptability

  Immediately after consumption

• 24 hour food intake

  24 hours

Other Outcomes (1)

• Gastrointestinal Symptoms

  At baseline (0 minute) and 120 minutes post-consumption

Study Arms (2)

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.

Other: Control Bread; Other: Chickpea-Enriched Arabic Bread; Other: Pea-Enriched Arabic Bread; Other: Lentil-Enriched Arabic Bread

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.

Other: Control Bread; Other: Chickpea-Enriched Arabic Bread; Other: Pea-Enriched Arabic Bread; Other: Lentil-Enriched Arabic Bread

Interventions

Control Bread OTHER

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

Chickpea bread followed by control bread; Control bread followed by chickpea bread

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)

Chickpea bread followed by control bread; Control bread followed by chickpea bread

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)

Chickpea bread followed by control bread; Control bread followed by chickpea bread

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)

Chickpea bread followed by control bread; Control bread followed by chickpea bread

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

School of Biosciences, University of Nottingham, Sutton Bonington Campus, United Kingdom

Nottingham, United Kingdom

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Wejdan Shamakhay, Phd Student

CONTACT

+44; alyws7@nottingham.ac.uk

Simon Welham, Associate Professor

CONTACT

simon.welham@nottingham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be masked to the type of bread they are consuming at each visit.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student, Clinical Nutrition

Model Details: 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)

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 17, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)