Crocus Sativus Tepals Water Extract in Obesity and Prediabetes

Summary

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.

Timeline

Start

2026-02-06

Primary completion

2026-06

Completion

2026-12

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

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