OverweightNCT07652320
Glycaemic Response of Arabic Bread
A study testing Chickpea-Enriched Arabic Bread, Pea-Enriched Arabic Bread and Lentil-Enriched Arabic Bread in people with Overweight and Obesity, run by University of Nottingham at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity, Glycaemic Response
- What is being tested?
- Chickpea-Enriched Arabic Bread, Pea-Enriched Arabic Bread and Lentil-Enriched Arabic Bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Simon Welham, Associate Professor contact
United Kingdom1 site
School of Biosciences, University of Nottingham, Sutton Bonington Campus, United Kingdom
Nottingham
Simon Welham, Associate Professor, 0115 951 6129, simon.welham@nottingham.ac.uk
Wejdan Shamakhay, PhD Student, alyws7@nottingham.ac.uk
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Overweight, Obesity, Glycaemic Response
- Being tested
- Control Bread, Chickpea-Enriched Arabic Bread, Pea-Enriched Arabic Bread, Lentil-Enriched Arabic Bread
- Keywords
- Glycaemic Response, Arabic Bread, Legume Flour, Wheat Flour, Postprandial Glucose, Overweight, Obesity, Satiety, Appetite, Crossover Study
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control BreadOther
Arabic bread prepared with 100% wheat flour, providing an equivalent of 50g of available carbohydrate.
Chickpea-Enriched Arabic BreadOther
Arabic bread prepared with 30% chickpea flour and 70% wheat flour, providing an equivalent of 50g available carbohydrate.
(This is the primary experimental comparison)
Pea-Enriched Arabic BreadOther
Arabic bread prepared with 30% pea flour and 70% wheat flour, providing an equivalent of 50g available carbohydrate.
(Optional secondary comparison)
Lentil-Enriched Arabic BreadOther
Arabic bread prepared with 30% lentil flour and 70% wheat flour, providing an equivalent of 50g available carbohydrate.
(Optional secondary comparison)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control Bread; Other: Chickpea-Enriched Arabic Bread; Other: Pea-Enriched Arabic Bread; Other: Lentil-Enriched Arabic Bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial Blood Glucose Response
Differences in the iAUC for capillary blood glucose will be compared between bread formulations.
Measured: 120 minutes
Secondary outcomes (4)
Peak Postprandial Capillary Blood Glucose
Differences in the peak capillary blood glucose value after consuming each bread formulation.
Measured: 120 minutes
Appetite Response
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).
Measured: 120 minutes
Sensory Acceptability
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.
Measured: Immediately after consumption
24 hour food intake
Total energy intake, macronutrient intake until midnight after product consumption.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study startJun 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wejdan Shamakhay, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07652320
- Sponsor's protocol ID
- FMHS 238-0925
- Status last verified
- May 2026
- First submitted
- 10 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycaemic Response to Arabic Bread Formulated With Alternative Flour Blends: A Comparison With Arabic Wheat Bread
- ClinicalTrials.gov ID
- NCT07652320
- Acronym / sponsor ID
- FMHS 238-0925
- Conditions
- Overweight, Obesity, Glycaemic Response
- Keywords
- Glycaemic Response, Arabic Bread, Legume Flour, Wheat Flour, Postprandial Glucose, Overweight, Obesity, Satiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Control bread followed by chickpea bread | Experimental | Other: Control Bread, Other: Chickpea-Enriched Arabic Bread, Other: Pea-Enriched Arabic Bread, Other: Lentil-Enriched Arabic BreadParticipants 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. |
| Chickpea bread followed by control bread | Experimental | Other: Control Bread, Other: Chickpea-Enriched Arabic Bread, Other: Pea-Enriched Arabic Bread, Other: Lentil-Enriched Arabic BreadParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control BreadArabic bread prepared with 100% wheat flour, providing an equivalent of 50g of available carbohydrate. | Other | Chickpea bread followed by control bread, Control bread followed by chickpea bread |
| Chickpea-Enriched Arabic BreadArabic bread prepared with 30% chickpea flour and 70% wheat flour, providing an equivalent of 50g available carbohydrate. (This is the primary experimental comparison) | Other | Chickpea bread followed by control bread, Control bread followed by chickpea bread |
| Pea-Enriched Arabic BreadArabic bread prepared with 30% pea flour and 70% wheat flour, providing an equivalent of 50g available carbohydrate. (Optional secondary comparison) | Other | Chickpea bread followed by control bread, Control bread followed by chickpea bread |
| Lentil-Enriched Arabic BreadArabic bread prepared with 30% lentil flour and 70% wheat flour, providing an equivalent of 50g available carbohydrate. (Optional secondary comparison) | Other | Chickpea bread followed by control bread, Control bread followed by chickpea bread |
Primary outcome
Postprandial Blood Glucose Response
Time frame: 120 minutes
Differences in the iAUC for capillary blood glucose will be compared between bread formulations.
4 secondary outcomes
Peak Postprandial Capillary Blood Glucose
Time frame: 120 minutes
Appetite Response
Time frame: 120 minutes
Sensory Acceptability
Time frame: Immediately after consumption
24 hour food intake
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Simon Welham, Associate Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chickpea-Enriched Arabic Bread, Pea-Enriched Arabic Bread and Lentil-Enriched Arabic Bread in people with Overweight and Obesity, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wejdan Shamakhay, Phd Student (+44, alyws7@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial Blood Glucose Response (time frame: 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.