About this trial
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.
Eligibility criteria
Qualifiers
Obesity type I (ITM > 30 kg/m2) and/or
Prediabetes (fasting glucose levels 6,1 - 6,9 mmol/L)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Crocus sativus tepals cold aqueous extract
- cold water
Treatment groups
Sponsors and collaborators
University of Primorska
Lead sponsor
Università Politecnica delle Marche
Collaborator