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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 65
Healthy Volunteers: f
View:

• Obesity type I (ITM \> 30 kg/m2) and/or

• Prediabetes (fasting glucose levels 6,1 - 6,9 mmol/L)

Locations
Other Locations
Slovenia
University pf Primorska, Faculty of Health Sciences
RECRUITING
Izola
Contact Information
Primary
Nina Mohorko, PhD
nina.mohorko@fvz.upr.si
+386 5 66 35 818
Time Frame
Start Date: 2026-02-06
Estimated Completion Date: 2026-12
Participants
Target number of participants: 20
Treatments
Experimental: Crocus sativus
Crocus sativus tepals cold aqueous extract
Sham_comparator: water
cold water
Related Therapeutic Areas
Sponsors
Leads: University of Primorska
Collaborators: Università Politecnica delle Marche

This content was sourced from clinicaltrials.gov