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Legume Flour Particle Size and Metabolic Responses to Bread

Study acronym: PULSE
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated August 21, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Harokopio University

Record History

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  1. Notable Primary endpoint(s) modified
    • Secondary endpoints revised (2)
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT07716059
Lead Sponsor Harokopio University
Collaborators: National and Kapodistrian University of Athens
Conditions
(from sponsor)
Type 2 Diabetes
Related terms Diabetes Mellitus, Type 2
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov