RecruitingNot Applicable

Legume Flour Particle Size and Metabolic Responses to Bread

Greece35 participantsStarted 2025-09-29

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 m…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Postprandial incremental blood glucose area under the curve (iAUC₀-₁₈₀ min), measured by continuous glucose monitoring, after consumption of the bread enriched with 30% larger particle size compared with white wheat bread.

Timeframe: 0-180 minutes postprandially.

Trial details

NCT IDNCT07716059

SponsorHarokopio University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

Maria Christina Kanata, MSc

+306937900141 mckanata@hua.gr

View on ClinicalTrials.gov More Type 2 Diabetes trials