NCT07261475

Crocus Sativus Tepals Water Extract in Obesity and Prediabetes

Acute Effects of Water Extract of Crocus Sativus Tepals on Metabolic Health Parameters in Patients With Obesity and Prediabetes

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Primorska · Academic / Other
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prediabetes
• Obesity & Overweight

Interventions

Type	Name	Description
BIOLOGICAL	Crocus sativus tepals cold aqueous extract	2 g of Crocus sativus tepals will be infused in 200 mL of water overnight at 4 °C, resulting cold aqueous extract corresponds to 40 mg GAE of polyphenols
BIOLOGICAL	cold water	200 mL of cold water, kept overnight at 4 °C

Timeline

• Start date: 2026-02-06
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2025-12-03
• Last updated: 2026-02-04

Locations

1 site across 1 country: Slovenia