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NCT07716059
Legume Flour Particle Size and Metabolic Responses to Bread
Conditions: Type 2 Diabetes
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 35
Sponsor: Harokopio University
Location: Harokopio University Athens Attica
Summary
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
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 (\ 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.
Source: ClinicalTrials.gov (NCT07716059). StuddyBuddy aggregates publicly available trial information.