Legume Flour Particle Size and Metabolic Responses to Bread

Recruiting now · Not applicable

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT07716059

Run by

Harokopio University

People needed

35

Starts

2025-09-29

Expected to finish

2026-11-30

Last updated by the study team

2026-07-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

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