Legume Flour in Bread and Blood Sugar Responses

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants consume bread containing 0%/30% finely milled chickpea flour or 30% coarsely milled chickpea flour, delivering about 50 g of available carbohydrates, while continuous glucose monitoring tracks glucose for 6 hours across two meals. The study includes two age-appropriate groups: healthy adults (18–35) and adults with type 2 diabetes (40–65). Outcomes include postprandial glucose excursions and appetite sensations measured by visual analogue scales. Three bread formulations are tested to evaluate the effect of legume particle size on glycemic response and appetite. The design is exploratory, aiming to understand how ingredient structure can influence metabolic responses in T2DM and in non-diabetic individuals.

Why it matters

Who can join: the full rules

Cohort Healthy Participants

Inclusion Criteria:

* Age: Adults aged 18-35 years.
* Health Status: Healthy individuals with no diagnosed chronic diseases, including diabetes, cardiovascular disease, or gastrointestinal disorders.
* Body Mass Index (BMI): 18.5-27 kg/m² (normal to overweight range).
* Fasting Glucose: Normal fasting plasma glucose (\<100 mg/dL or \<5.6 mmol/L).
* No regular use of medications known to affect glucose metabolism (e.g., insulin, metformin, corticosteroids).
* Ability and willingness to comply with study procedures, including continuous glucose monitoring and standardized test meals.
* Informed Consent: Ability to understand and provide written informed consent.

Exclusion Criteria:

* Diagnosed chronic diseases: Diabetes (type 1 or type 2), cardiovascular disease, kidney or liver disease, gastrointestinal disorders (e.g., celiac disease, inflammatory bowel disease).
* Abnormal glucose metabolism: Fasting plasma glucose ≥100 mg/dL (≥5.6 mmol/L) or HbA1c ≥5.7%.
* Medication use: Regular use of medications that affect glucose metabolism, insulin sensitivity, or digestion (e.g., metformin, corticosteroids, GLP-1 analogs).
* Allergies or intolerances: Allergy or intolerance to wheat, chickpeas, gluten, or other ingredients used in the study foods.
* Pregnancy or lactation: Women who are pregnant, breastfeeding, or planning pregnancy during the study period.
* Recent major weight change: Significant weight loss or gain (\>5% body weight) in the past 3 months.
* Extreme physical activity: Competitive athletes or individuals engaging in extreme exercise regimens that could influence glucose metabolism.
* Inability to comply: Individuals unable or unwilling to follow study procedures, including continuous glucose monitoring and standardized test meals.

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.

Where it's running

• Harokopio University
  Athens, Attica, Greece Recruiting
• 1st Department of Propaedeutic Internal Medicine, Medical School, National and Kapodistrian University of Athens, Laiko General Hospital, 15772 Athens, Greece
  Athens, Attica, Greece Recruiting

Study contacts

• Study coordinator: Maria Christina Kanata, MSc
• Email: mckanata@hua.gr
• Phone: +306937900141

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.