Clinical trial

Crocus Sativus Tepals Water Extract in Obesity and Prediabetes

Recruiting now · Early Phase 1 · 1 countries · Registry ID NCT07261475

Recruiting nowEarly Phase 1Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age40 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionPrediabetes, Obesity & Overweight

Full registry criteria

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

Treatments and study arms

Crocus sativus tepals cold aqueous extract

Biological

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

cold water

Biological

200 mL of cold water, kept overnight at 4 °C

Primary outcomes

glucose levelsFrom 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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University pf Primorska, Faculty of Health Sciences🌐 Izola, Slovenia

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Nina Mohorko, PhDContact

Email · Call +386 5 66 35 818

Ana Petelin, PhDContact

Email · Call +386 5 66 26 469

Nina Mohorko, PhDPrincipal Investigator