Crocus Sativus Tepals Water Extract in Obesity and Prediabetes

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

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.

Inclusion Criteria:

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

Exclusion Criteria:

• 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