Saffron (Crocus sativus) tepal water extract for lowering meal-time blood sugar in obesity and prediabetes
Official title: Acute Effects of Water Extract of Crocus Sativus Tepals on Metabolic Health Parameters in Patients With Obesity and Prediabetes
Run by University of Primorska · NCT07261475 · Data updated 2026-11-12
This study tests whether drinking a cold water extract made from saffron tepals before a meal can lower blood sugar after eating in adults with obesity or prediabetes.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 40 Years to 65 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | University of Primorska Academic / other |
| Locations | 1 site (Izola) |
| Status | Recruiting |
| Started | February 6, 2026 |
| Main results expected | June 2026 |
| Study ends | December 2026 |
| Registry record updated | February 4, 2026 |
| Trial ID | NCT07261475 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with BMI over 30 (but not greater than 35) and/or fasting glucose in the prediabetic range (6.1–6.9 mmol/L), who are not pregnant, do not have diabetes, and have no major medical or gastrointestinal exclusions are ideal candidates.
✕Probably not a fit
People with diagnosed diabetes, BMI above 35 kg/m2, celiac disease or gluten intolerance, significant medical or psychiatric illness, pregnancy or lactation, electronic implants, or recent participation in other trials are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, two-visit crossover early-phase 1 trial comparing a single dose of cold aqueous extract of Crocus sativus tepals to cold water, each given 5 minutes before a standardized meal of 100 g white bread. Adults with type I obesity (BMI >30 and ≤35 kg/m2) and/or prediabetes (fasting glucose 6.1–6.9 mmol/L) attend two in-person visits in random order to receive each intervention. Primary measurements include postprandial glycemia and insulin responses, with secondary measures such as resting energy expenditure and blood pressure taken acutely. Participants with diabetes, major medical conditions, pregnancy, celiac disease, electronic implants, or BMI >35 are excluded.
Why it matters
Potential benefit: If successful, the extract could offer a simple, low-cost way to reduce post-meal blood sugar spikes and possibly modestly increase resting energy use for people with obesity or prediabetes.
How similar studies have gone: Some small animal and human studies of saffron stigma and other saffron extracts have shown modest metabolic benefits, but use of tepal cold aqueous extract in humans is novel and not well established.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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University pf Primorska, Faculty of Health Sciences
Izola, Slovenia Recruiting
Study contacts
- Principal investigator: Nina Mohorko, PhD — University pf Primorska, Faculty of Health Sciences
- Study coordinator: Nina Mohorko, PhD
- Email: nina.mohorko@fvz.upr.si
- Phone: +386 5 66 35 818
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.