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Crocus Sativus Tepals Water Extract in Obesity and Prediabetes

Crocus Sativus Tepals Water Extract in Obesity and Prediabetes

Recruiting
40-65 years
All
Phase 0

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Overview

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.

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study details
    Prediabetes
    Obesity & Overweight

NCT07261475

University of Primorska

1 February 2026

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