Crocus Sativus Tepals Water Extract in Obesity and Prediabetes

Recruiting now · Early Phase 1

Conditions studied: Prediabetes, Obesity & Overweight

In brief

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.

Key facts

Study ID

NCT07261475

Run by

University of Primorska

People needed

20

Starts

2026-02-06

Expected to finish

2026-12-01

Last updated by the study team

2026-02-04

Who can join

Age: 40 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Obesity type I (ITM > 30 kg/m2) and/or
• Prediabetes (fasting glucose levels 6,1 - 6,9 mmol/L)

You may not qualify if…

• Gastrointestinal diseases
• Diabetes mellitus of any type
• Pregnant or lactating, without contraception
• Serious clinical conditions such as cancer, severe infections, severe psychiatric disorders, autoimmune diseases, inflammatory diseases
• Participation in another clinical trial 3 months prior to the study
• ITM greater than 35 kg/m2
• Celiac disease of gluten intolerance
• electronic implant

Where it is running

• University pf Primorska, Faculty of Health Sciences — Izola, Slovenia (enrolling)

Full record on ClinicalTrials.gov

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