Crocus Sativus Tepals Water Extract in Obesity and Prediabetes

Официальное название

Acute Effects of Water Extract of Crocus Sativus Tepals on Metabolic Health Parameters in Patients With Obesity and Prediabetes

Обзор

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.

Вмешательства

• Биопрепарат 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
• Биопрепарат cold water
  200 mL of cold water, kept overnight at 4 °C

Первичные конечные точки

• glucose levels [Срок оценки: From enrollment to the end of second measurement at 2 weeks]

Вторичные конечные точки (3)

• insulin level [Срок оценки: From enrollment to the end of second measurement at 2 weeks.]
• Resting metabolism [Срок оценки: From enrollment to the end of the second measurement, at 2 weeks]
• Blood pressure [Срок оценки: baseline, 60 minutes after bread ingestion, 120 minutes after bread ingestion]

Критерии участия

Критерии включения

• Obesity type I (ITM > 30 kg/m2) and/or
• Prediabetes (fasting glucose levels 6,1 - 6,9 mmol/L)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Словения · 1 центр

• University pf Primorska, Faculty of Health Sciences — Izola

Публикации

• 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. PMID 39566886
• 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. PMID 25386395
• 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. PMID 31382514
• 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. PMID 22809329
• 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. PMID 29803496
• 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. PMID 38318672
• 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. PMID 37298165

Идентификаторы

NCT: NCT07261475 · ZAFRAN-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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