An interventional study of Wheat bread with 30% finely milled chickpea flour and Conventional white wheat bread in Type 2 Diabetes, sponsored by Harokopio University. Recruiting at 2 sites in Greece. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Harokopio University · Not applicable, Interventional, and Other
The aim of the study is to investigate the effect of partial replacement of wheat flour by legume flour of different particle sizes on postprandial glucose responses and appetite sensations in healthy subjects and patients with type 2 diabetes.
Subjects will consume a portion of bread enriched with legume flours yielding 50 g of available carbohydrates as breakfast meal. To investigate the effect of the bread on glycemic response, a continuous glucose monitoring system (CGM) will be used. After an 180-min period, subjects will be given a second meal and glycemic response will be monitored for another 180 min. During the trial subjects must fill appropriate visual analogue scales regarding appetite sensations.
The clinical trial will include two groups: (a) apparently healthy adults (up to 35 years old) and (b) individuals diagnosed with T2DM (aged 40-65 years). The study will investigate the effect of flour particle size on postprandial glycemic responses to bread and appetite sensations.
Within the framework of the clinical study, a total of three bread products will be prepared. Their final recipes will be determined after a series of tests to ensure the desired properties and organoleptic characteristics.
Intervention 1: White wheat bread with conventional fine wheat flour Intervention 2: White wheat bread with the addition of 30% finely milled chickpea flour Intervention 3: White wheat bread with the addition of 30% chickpea flour of larger particle size (>1.6 mm)
Inclusion and Exclusion Criteria
Group 1
Participants in Group 1 will be men and women aged 40-65 years with BMI \< 31 kg/m², fasting glucose > 125 mg/dL, and HbA1c \< 8.5%, diagnosed with T2DM for at least one year before entering the study.
Patients must be on stable treatment (hypoglycemic, lipid-lowering, antihypertensive) for at least 3 months prior to enrolment. Most participants will be individuals monitored at the Diabetes Clinic of the 1st Propaedeutic Department of Internal Medicine at Laiko General Hospital.
Individuals with conditions that could affect study outcomes (e.g., endocrine, cardiovascular, pulmonary, renal, or gastrointestinal disorders), those with sensitivity, intolerance, or allergy to any bread ingredients used in the clinical trial, pregnant or breastfeeding women, individuals with eating disorders, and those taking medications or supplements considered incompatible with the study will be excluded.
Group 2 will consist of apparently healthy men and women aged 18-35 years with BMI 18-25 kg/m², who are not following a diet program or dietary counseling during the study period.
Individuals with fasting glucose > 110 mg/dL, blood pressure > 160/100 mmHg, metabolic or dietary disorders, conditions that could affect the study outcomes (e.g., endocrine, cardiovascular, pulmonary, renal, or gastrointestinal diseases), those with sensitivity, intolerance, or allergy to the bread ingredients used, pregnant or breastfeeding women, and those taking medications that could affect the study (e.g., hypoglycemic drugs, appetite-modifying medications, or any other relevant medications) will be excluded.
All volunteers, after providing informed written consent, will undergo a blood sample collection to confirm eligibility based on defined criteria, as well as for additional hematological and biochemical analyses. Subsequently, each participant will have a Continuous Glucose Monitoring (CGM) sensor placed by trained personnel according to the manufacturer's instructions, in order to monitor glucose values throughout the postprandial protocol. Measurements will include the period following consumption of the first meal (bread) and a second standardized meal, consumed 3 h later.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 35 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Harokopio University is the lead sponsor of 66 studies on the registry; 9 are open to participants now.
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Cohort Healthy Participants
Inclusion Criteria:
Exclusion Criteria:
Cohort 2: Participants with Type 2 Diabetes Mellitus
Men and women aged 40-75 years. Body mass index (BMI) \< 31 kg/m². Fasting plasma glucose > 125 mg/dL. HbA1c \< 8.5%. Diagnosis of type 2 diabetes mellitus (T2DM) for at least 1 year before enrolment.
Stable treatment with hypoglycaemic, lipid-lowering, and/or antihypertensive medications for at least 3 months prior to enrolment.
Most participants will be recruited from the Diabetes Clinic of the 1st Propaedeutic Department of Internal Medicine, Laiko General Hospital.
Exclusion criteria
Endocrine, cardiovascular, pulmonary, renal, or gastrointestinal disorders that could affect study outcomes.
Sensitivity, intolerance, or allergy to any ingredients of the study breads. Pregnancy or breastfeeding. Eating disorders. Use of medications or dietary supplements considered incompatible with the study protocol.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Study participants will consume a single serving of refined white wheat bread prepared from finely milled flour, providing 50 g of available carbohydrate, and served as a control test meal under controlled conditions.
Dietary Supplement: Conventional white wheat bread
Study Participants will consume a single serving of wheat bread in which 30% of finely milled wheat flour is replaced with finely milled chickpea flour, providing 50 g of available carbohydrate, served as a test meal under controlled conditions.
Dietary Supplement: Wheat bread with 30% finely milled chickpea flour
Study Participants will consume a single serving of wheat bread in which 30% of finely milled wheat flour is replaced with larger particle size chickpea flour providing 50 g of available carbohydrate, served as a test meal under controlled conditions.
Dietary Supplement: Wheat bread with 30% coarse chickpea flour
Wheat bread formulated by replacing 30% of refined wheat flour with finely milled chickpea flour, providing 50 g of available carbohydrates
Conventional white wheat bread providing 50 g of available carbohydrate
Wheat bread formulated by replacing 30% of refined wheat flour with coarse chickpea flour, providing 50 g of available carbohydrate.
Postprandial incremental blood glucose area under the curve (iAUC₀-₁₈₀ minutes), measured by continuous glucose monitoring, after consumption of the bread enriched with 30% larger particle size compared with white wheat bread.
For the study in healthy subjects a sample size of 20 adults is needed, based on a power calculation with an α of 0.05 and power of 0.80 to detect a between white wheat bread difference of 20% in postprandial glycemia. For the study in diabetic patients a sample size of 14 adults is needed, based on a power calculation with an α of 0.05 and power of 0.80 to detect a between white wheat bread difference of 30% in postprandial glycemia.
Time frame: 0-180 minutes postprandially.
Postprandial incremental blood glucose area under the curve (iAUC₀-₁₈₀ minutes), measured by continuous glucose monitoring, after consumption of bread enriched with 30% chickpea flour compared with white wheat bread.
Postprandial blood glycemic response in healthy individuals, assessed by the incremental area under the glucose curve (iAUC₀-₁₈₀ minutes) using continuous glucose monitoring, following consumption of bread enriched with with 30% chickpea flour compared with white wheat bread.
Time frame: 0-180 minutes postprandially
Postprandial incremental blood glucose area under the curve (iAUC₀-₁₈₀ minutes) measured by continuous glucose monitoring, after consumption of the bread enriched with 30% larger particle size compared with bread enriched with 30% refined chickpea flour
Postprandial blood glycaemic response in healthy individuals, as assessed by the incremental area under the glucose curve (iAUC₀-₁₈₀ minutes) measured by continuous glucose monitoring following consumption of bread enriched with 30% larger particle size chickpeas compared with bread enriched with 30% refined chickpea flour. Glucose concentrations will be recorded continuously, and iAUC will be calculated over the 0-180 minutes postprandial period using the trapezoidal method, with baseline glucose defined as the mean glucose concentration during the 15 minutes prior to bread consumption.
Time frame: 0-180 minutes
Plan to share: No — There are no plans to share individual participant data collected during this study.
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