NCT07261475RecruitingEarly phase 1
Crocus Sativus Tepals Water Extract in Obesity and Prediabetes
Acute Effects of Water Extract of Crocus Sativus Tepals on Metabolic Health Parameters in Patients With Obesity and Prediabetes
Source: ClinicalTrials.gov · Last updated 4 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 22 Nov 2025
- Start date
- 6 Feb 2026
- Primary completion date
- Jun 2026
- Lead sponsor
- University of Primorska
- Diseases
- Obesity
- NCT number
- NCT07261475
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 20
- From 6 Feb 2026 to the primary completion date, Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another clinical trial 3 months prior to the study
- electronic implant
Other illness
- Gastrointestinal diseases
- Diabetes mellitus of any type
- Serious clinical conditions such as cancer, severe infections, severe psychiatric disorders, autoimmune diseases, inflammatory diseases
- Celiac disease of gluten intolerance
Other
- Pregnant or lactating, without contraception
- ITM greater than 35 kg/m2
Who the study is looking for
- Obesity type I (ITM \> 30 kg/m2) and/or
- Prediabetes (fasting glucose levels 6,1 - 6,9 mmol/L)
Age in the registry: 40 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University pf Primorska, Faculty of Health Sciences Coordinator of this site? Confirm its status | Izola | Slovenia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.