Legume Flour Particle Size and Metabolic Responses to Bread
ConditionType 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHarokopio University
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Wheat bread with 30% finely milled chickpea flour
- Conventional white wheat bread
- Wheat bread with 30% coarse chickpea flour
Treatment groups
35 Participants
are divided into 3 treatment groupsSponsors and collaborators
Harokopio University
Lead sponsor
National and Kapodistrian University of Athens
Collaborator
Source ClinicalTrials.gov