Actively Recruiting
Crocus Sativus Tepals Water Extract in Obesity and Prediabetes
Led by University of Primorska · Updated on 2026-02-04
20
Participants Needed
1
Research Sites
42 weeks
Total Duration
On this page
Sponsors
U
University of Primorska
Lead Sponsor
U
Università Politecnica delle Marche
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Crocus Sativus Tepals Water Extract in Obesity and Prediabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 40 to 65 years
- Obesity type I (BMI > 30 kg/m2) and/or prediabetes (fasting glucose 6.1 - 6.9 mmol/L)
You will not qualify if you...
- Gastrointestinal diseases
- Any type of diabetes mellitus
- 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 within 3 months prior to this study
- BMI greater than 35 kg/m2
- Celiac disease or gluten intolerance
- Presence of electronic implants
AI-Screening
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Trial Site Locations
Total: 1 location
1
University pf Primorska, Faculty of Health Sciences
Izola, Slovenia, 6310
Actively Recruiting
Research Team
N
Nina Mohorko, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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