NCT Number: NCT07261475
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.
Interested in participating?
Request Info40 year–65 year
All sexes
Interventional
Early Phase 1
Izola, 6310, Slovenia
Location status: Recruiting
Ana Petelin, PhD
CONTACT
Ana Petelin, PhD
SUB_INVESTIGATOR
Bernarda Habe
SUB_INVESTIGATOR
Nina Mohorko, PhD
CONTACT
Nina Mohorko, PhD
PRINCIPAL_INVESTIGATOR
Tanja Črešnovar
SUB_INVESTIGATOR
Zala Jenko Pražnikar, PhD
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: From enrollment to the end of second measurement at 2 weeks
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.
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 the second measurement, at 2 weeks
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: baseline, 60 minutes after bread ingestion, 120 minutes after bread ingestion
Contact information is provided by the study sponsor or research team.
University of Primorska
Other
Acute Effects of Water Extract of Crocus Sativus Tepals on Metabolic Health Parameters in Patients With Obesity and Prediabetes
Acronym: ZAFRAN
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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