Type 2 Diabetes (T2D) Clinical Trials

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Effects of Legume Flour Particle Size on Postprandial Metabolic Responses to Bread of Healthy Subjects and Patients With Type 2 Diabetes

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Greece
1st Department of Propaedeutic Internal Medicine, Medical School, National and Kapodistrian University of Athens, Laiko General Hospital, 15772 Athens, Greece
RECRUITING
Athens
Harokopio University
RECRUITING
Athens
Contact Information
Primary
Maria Christina Kanata, MSc
mckanata@hua.gr
+306937900141
Backup
Amalia E Yanni, PhD
ayanni@hua.gr
Time Frame
Start Date: 2025-09-29
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 35
Treatments
Placebo_comparator: Conventional White Bread exclusively prepared with 100% White flour
Study participants will consume a single serving of refined white wheat bread prepared from finely milled flour, providing 50 g of available carbohydrate, and served as a control test meal under controlled conditions.
Active_comparator: Wheat bread in which 30% of white flour is substituted with finely milled chickpea flour
Study Participants will consume a single serving of wheat bread in which 30% of finely milled wheat flour is replaced with finely milled chickpea flour, providing 50 g of available carbohydrate, served as a test meal under controlled conditions.
Active_comparator: Wheat bread in which 30% of white flour is substituted with larger particle size chickpea flour
Study Participants will consume a single serving of wheat bread in which 30% of finely milled wheat flour is replaced with larger particle size chickpea flour providing 50 g of available carbohydrate, served as a test meal under controlled conditions.
Related Therapeutic Areas
Sponsors
Collaborators: National and Kapodistrian University of Athens
Leads: Harokopio University

This content was sourced from clinicaltrials.gov