Crocus Sativus Tepals Water Extract in Obesity and Prediabetes

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age40-65
SponsorUniversity of Primorska

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

20 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Primorska

Lead sponsor

Università Politecnica delle Marche

Collaborator