Crocus Sativus Tepals Water Extract in Obesity and Prediabetes
NCT ID: NCT07261475
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
EARLY_PHASE1
20 participants
INTERVENTIONAL
2026-01-31
2026-12-31
Brief Summary
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* 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Crocus sativus
Crocus sativus tepals cold aqueous extract
Crocus sativus tepals cold aqueous extract
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
water
cold water
cold water
200 mL of cold water, kept overnight at 4 °C
Interventions
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Crocus sativus tepals cold aqueous extract
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
cold water
200 mL of cold water, kept overnight at 4 °C
Eligibility Criteria
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Inclusion Criteria
* Prediabetes (fasting glucose levels 6,1 - 6,9 mmol/L)
Exclusion Criteria
* 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
40 Years
65 Years
ALL
No
Sponsors
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Università Politecnica delle Marche
OTHER
University of Primorska
OTHER
Responsible Party
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Nina Mohorko
Associate professor
Principal Investigators
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Nina Mohorko, PhD
Role: PRINCIPAL_INVESTIGATOR
University pf Primorska, Faculty of Health Sciences
Locations
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University pf Primorska, Faculty of Health Sciences
Izola, , Slovenia
Countries
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Central Contacts
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Facility Contacts
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Nina Mohorko, PhD
Role: primary
Ana Petelin, PhD
Role: backup
References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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ZAFRAN-2025
Identifier Type: -
Identifier Source: org_study_id