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| Name | Class |
|---|---|
| Università Politecnica delle Marche | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crocus sativus | Experimental | Crocus sativus tepals cold aqueous extract |
|
| water | Sham Comparator | cold water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crocus sativus tepals cold aqueous extract | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| glucose levels | Serum glucose levels will be measured from venous blood at baseline and 60 and 120 minutes after bread ingestion. | From enrollment to the end of second measurement at 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| insulin level | Serum insulin levels will be measured from venous blood at baseline and 60 and 120 minutes after bread ingestion. | From enrollment to the end of second measurement at 2 weeks. |
| Resting metabolism |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nina Mohorko, PhD | Contact | +386 5 66 35 818 | nina.mohorko@fvz.upr.si |
| Name | Affiliation | Role |
|---|---|---|
| Nina Mohorko, PhD | University pf Primorska, Faculty of Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University pf Primorska, Faculty of Health Sciences | Recruiting | Izola | 6310 | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39566886 | Background | Barik SK, Sengupta S, Arya R, Kumar S, Kim JJ, Chaurasia R. Dietary Polyphenols as Potential Therapeutic Agents in Type 2 Diabetes Management: Advances and Opportunities. Adv Nutr. 2025 Jan;16(1):100346. doi: 10.1016/j.advnut.2024.100346. Epub 2024 Nov 19. | |
| 25386395 | Background | Omidi A, Riahinia N, Montazer Torbati MB, Behdani MA. Hepatoprotective effect of Crocus sativus (saffron) petals extract against acetaminophen toxicity in male Wistar rats. Avicenna J Phytomed. 2014 Sep;4(5):330-6. |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D009765 | Obesity |
| D050177 | Overweight |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| cold water | Biological | 200 mL of cold water, kept overnight at 4 °C |
|
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).
| From enrollment to the end of the second measurement, at 2 weeks |
| Blood pressure | baseline, 60 minutes after bread ingestion, 120 minutes after bread ingestion |
| 31382514 | Background | Moratalla-Lopez N, Bagur MJ, Lorenzo C, Salinas MEMR, Alonso GL. Bioactivity and Bioavailability of the Major Metabolites of Crocus sativus L. Flower. Molecules. 2019 Aug 2;24(15):2827. doi: 10.3390/molecules24152827. |
| 22809329 | Background | Montoro P, Maldini M, Luciani L, Tuberoso CI, Congiu F, Pizza C. Radical scavenging activity and LC-MS metabolic profiling of petals, stamens, and flowers of Crocus sativus L. J Food Sci. 2012 Aug;77(8):C893-900. doi: 10.1111/j.1750-3841.2012.02803.x. Epub 2012 Jul 18. |
| 29803496 | Background | Menghini L, Leporini L, Vecchiotti G, Locatelli M, Carradori S, Ferrante C, Zengin G, Recinella L, Chiavaroli A, Leone S, Brunetti L, Orlando G. Crocus sativus L. stigmas and byproducts: Qualitative fingerprint, antioxidant potentials and enzyme inhibitory activities. Food Res Int. 2018 Jul;109:91-98. doi: 10.1016/j.foodres.2018.04.028. Epub 2018 Apr 16. |
| 38318672 | Background | Bursac B, Bellachioma L, Gligorovska L, Jovanovic M, Teofilovic A, Vrataric M, Vojnovic Milutinovic D, Albacete A, Martinez-Melgarejo PA, Morresi C, Damiani E, Bacchetti T, Djordjevic A. Crocus sativus tepals extract suppresses subcutaneous adipose tissue hypertrophy and improves systemic insulin sensitivity in mice on high-fat diet. Biofactors. 2024 Jul-Aug;50(4):828-844. doi: 10.1002/biof.2043. Epub 2024 Feb 6. |
| 37298165 | Background | Bellachioma L, Morresi C, Albacete A, Martinez-Melgarejo PA, Ferretti G, Giorgini G, Galeazzi R, Damiani E, Bacchetti T. Insights on the Hypoglycemic Potential of Crocus sativus Tepal Polyphenols: An In Vitro and In Silico Study. Int J Mol Sci. 2023 May 24;24(11):9213. doi: 10.3390/ijms24119213. |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |