NCT07261475 Crocus Sativus Tepals Water Extract in Obesity and Prediabetes
| NCT ID | NCT07261475 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of Primorska |
| Condition | Prediabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-02-06 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2026-02-06 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Nina Mohorko, PhD
PRINCIPAL INVESTIGATOR
University pf Primorska, Faculty of Health Sciences
Frequently Asked Questions
Who can join the NCT07261475 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 65 Years, studying Prediabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07261475 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07261475 currently recruiting?
Yes, NCT07261475 is actively recruiting participants. Contact the research team at nina.mohorko@fvz.upr.si for enrollment information.
Where is the NCT07261475 trial being conducted?
This trial is being conducted at Izola, Slovenia.
Who is sponsoring the NCT07261475 clinical trial?
NCT07261475 is sponsored by University of Primorska. The principal investigator is Nina Mohorko, PhD at University pf Primorska, Faculty of Health Sciences. The trial plans to enroll 20 participants.
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