Crocus Sativus Tepals Water Extract in Obesity and Prediabetes

Sponsor
University of Primorska
Study ID
NCT07261475
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Obesity & Overweight
  • Prediabetes

Eligibility Criteria

Sex
ALL
Age
40 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Crocus sativus tepals cold aqueous extract — BIOLOGICAL
    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
  • cold water — BIOLOGICAL
    200 mL of cold water, kept overnight at 4 °C

Study Details

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 Dates

First listed
Dec 3, 2025
Start date
Feb 6, 2026
Status verified
Feb 2026
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Crocus sativus
    Crocus sativus tepals cold aqueous extract
  • Sham Comparator: water
    cold water

Primary Outcome Measure

glucose levels [ Time Frame: From enrollment to the end of second measurement at 2 weeks ]

Central Contacts

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