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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Crocus sativus tepals cold aqueous extract
Biological/Vaccine2 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
cold water
Biological/Vaccine200 mL of cold water, kept overnight at 4 °C
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Crocus sativusExperimental treatment 1 intervention
Group B: waterSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
glucose levels
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 weeksSecondary outcomes
1
insulin level
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 second measurement at 2 weeks.2
Resting metabolism
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
From enrollment to the end of the second measurement, at 2 weeks3
Blood pressure
Time frame
baseline, 60 minutes after bread ingestion, 120 minutes after bread ingestionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Primorska
Lead sponsor
Università Politecnica delle Marche
Collaborator
Source ClinicalTrials.gov