Prediabetes, Obesity & Overweight
Conditions
Keywords
Crocus sativus tepals, Glycaemia, Oral glucose tolerance test, resting metabolism, blood pressure, insulin
Brief summary
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.
Interventions
BIOLOGICALCrocus sativus tepals cold aqueous extract
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
BIOLOGICALcold water
200 mL of cold water, kept overnight at 4 °C
Sponsors
University of Primorska
Università Politecnica delle Marche
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| glucose levels | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| insulin level | 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. |
| Resting metabolism | 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). |
| Blood pressure | baseline, 60 minutes after bread ingestion, 120 minutes after bread ingestion | — |
Countries
Slovenia
Contacts
CONTACTNina Mohorko, PhD
PRINCIPAL_INVESTIGATORNina Mohorko, PhD
University pf Primorska, Faculty of Health Sciences
Outcome results
None listed