An Early Phase 1 interventional study of Crocus sativus tepals cold aqueous extract and cold water in Prediabetes and Obesity & Overweight, sponsored by University of Primorska. Recruiting at 1 site in Slovenia. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-04.
Sponsored by University of Primorska · Early Phase 1, Interventional, and Treatment
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:
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.
918 studies on the registry are indexed under Prediabetic State; 232 are open to participants now.
This study's planned enrollment of 20 is below the median of 62 across 762 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →University of Primorska is the lead sponsor of 56 studies on the registry; 7 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Crocus sativus tepals cold aqueous extract
Biological: Crocus sativus tepals cold aqueous extract
cold water
Biological: cold water
2 g of Crocus sativus tepals will be infused in 200 mL of water overnight at 4 °C, resulting cold aqueous extract corresponds to 40 mg GAE of polyphenols
200 mL of cold water, kept overnight at 4 °C
glucose levels
Serum glucose levels will be measured from venous blood at baseline and 60 and 120 minutes after bread ingestion.
Time frame: From enrollment to the end of second measurement at 2 weeks
insulin level
Serum insulin levels will be measured from venous blood at baseline and 60 and 120 minutes after bread ingestion.
Time frame: From enrollment to the end of second measurement at 2 weeks.
Resting metabolism
Resting metabolism will be measured with indirect calorimetry at baseline in fasted state and at 40 and 100 minutes after bread ingestion. To determine RMR, subjects will lie relaxed on a bed in a thermoneutral room for 10 minutes to calm down, followed by a 20-minute measurement of oxygen consumption (VO2) and carbon dioxide production (VCO2). RMR and RQ will be calculated from stable values over a 15-minute period (the first 5 minutes of measurement until stabilization will not be taken into account).
Time frame: From enrollment to the end of the second measurement, at 2 weeks
Blood pressure
Time frame: baseline, 60 minutes after bread ingestion, 120 minutes after bread ingestion
Plan to share: No
Start is estimated for Feb 2026; primary completion for Jun 2026, 4 months later.
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