Clinical Trial

Crocus Sativus Tepals Water Extract in Obesity and Prediabetes

Study acronym: ZAFRAN
Recruiting Early Phase 1
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Record status
This record was last updated February 4, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this clinical trial is to determine the acute effects of ingestion of a cold aqueous extract of Crocus sativus tepals on postprandial glycemia and other indicators of metabolic health in patients with obesity and/or prediabetes. The main questions it aims to answer are: * Does the ingestion of Crocus sativus tepals cold aqueous extract prior to a meal improve the glycemic response to a standard meal? * How does the ingestion of Crocus sativus tepals aqueous extract prior to a meal impact insulin levels and other markers of metabolic health? * Does the ingestion of Crocus sativus tepals cold aqueous extract prior to a meal increase the resting energy expanditure? Researchers will compare Crocus sativus tepals cold aqueous extract to cold water. The participants will visit the Faculty twice - on one visit they will ingest Crocus sativus tepals cold aqueous extract and on the other cold water (in random order) 5 minutes prior to a standard meal of 100 g of white bread. On each visit, anthropometric measurements will be performed upon arrival. Blood samples will be collected 3 times, preceeded by resting metabolic rate and blood pressure measurements: at baseline in fasted conditions, and 60 minutes and 120 minutes after consuming the bread. There will be an at least 7 days wash-out period between the two visits.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-11-22; most recent amendment 2026-02-03.
Status change: Not Yet Recruiting → Recruiting 2026-01-05
Trial Details
NCT Number NCT07261475
Lead Sponsor University of Primorska
Collaborators: Università Politecnica delle Marche
Conditions Prediabetes, Obesity & Overweight
Enrollment 20 participants
Start Date 2026-02-06
Primary Completion 2026-06 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-02-04