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NCT07716059

Overview

NCT ID: NCT07716059
Lead Sponsor: Harokopio UniversityOTHER
Official Title: Effects of Legume Flour Particle Size on Postprandial Metabolic Responses to Bread of Healthy Subjects and Patients With Type 2 Diabetes
Brief 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.
Conditions: Type 2 Diabetes

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 21, 2026Actual
Start Date: Sep 29, 2025Actual
Primary Completion Date: Sep 30, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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 (<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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 35Estimated
Primary Purpose: Other
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: Single

Contacts and Locations

Central Contacts: Maria Christina Kanata, MScContact
mckanata@hua.gr+306937900141

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