NCT07716059Recruiting
Legume Flour Particle Size and Metabolic Responses to Bread
Effects of Legume Flour Particle Size on Postprandial Metabolic Responses to Bread of Healthy Subjects and Patients With Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 21 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 35 (estimated)
- First submitted
- 15 Jul 2026
- Start date
- Sept 2025
- Primary completion date
- Sept 2026
- Lead sponsor
- Harokopio University
- Diseases
- Type 2 diabetes
- NCT number
- NCT07716059
What you commit to
- Study type: Interventional
- Planned participants: 35
- From Sept 2025 to the primary completion date, Sept 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosed chronic diseases: Diabetes (type 1 or type 2), cardiovascular disease, kidney or liver disease, gastrointestinal disorders (e.g., celiac disease, inflammatory bowel disease).
- Allergies or intolerances: Allergy or intolerance to wheat, chickpeas, gluten, or other ingredients used in the study foods.
- 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.
Lab values
- 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).
- 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.
Other
- 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.
Who the study is looking for
- 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.
Criteria the registry did not label
- Cohort Healthy Participants
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 1st Department of Propaedeutic Internal Medicine, Medical School, National and Kapodistrian University of Athens, Laiko General Hospital, 15772 Athens, Greece Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Harokopio University Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.