Actively Recruiting

Early Phase 1
Age: 40Years - 65Years
All Genders
NCT07261475

Crocus Sativus Tepals Water Extract in Obesity and Prediabetes

Led by University of Primorska · Updated on 2026-02-04

20

Participants Needed

1

Research Sites

42 weeks

Total Duration

On this page

Sponsors

U

University of Primorska

Lead Sponsor

U

Università Politecnica delle Marche

Collaborating Sponsor

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

Crocus Sativus Tepals Water Extract in Obesity and Prediabetes

Who Can Participate

Age: 40Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 40 to 65 years
  • Obesity type I (BMI > 30 kg/m2) and/or prediabetes (fasting glucose 6.1 - 6.9 mmol/L)
Not Eligible

You will not qualify if you...

  • Gastrointestinal diseases
  • Any type of diabetes mellitus
  • 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 within 3 months prior to this study
  • BMI greater than 35 kg/m2
  • Celiac disease or gluten intolerance
  • Presence of electronic implants

AI-Screening

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Trial Site Locations

Total: 1 location

1

University pf Primorska, Faculty of Health Sciences

Izola, Slovenia, 6310

Actively Recruiting

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Research Team

N

Nina Mohorko, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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Crocus Sativus Tepals Water Extract in Obesity and Prediabetes | DecenTrialz