Recruiting EARLY_PHASE1 Prediabetes

New treatment option for Prediabetes

Official title Crocus Sativus Tepals Water Extract in Obesity and Prediabetes

ClinicalTrials.gov ID: NCT07261475

What this study is testing

What is Crocus sativus tepals cold aqueous extract?

Crocus sativus tepals cold aqueous extract is an investigational medicine, being studied as a potential treatment for prediabetes.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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?
  • Phase 1: an early, usually small safety study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 40 to 65

You may be able to join if

  • Obesity type I (ITM \> 30 kg/m2) and/or
  • Prediabetes (fasting glucose levels 6,1 - 6,9 mmol/L)

You likely can't join if

  • 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
See the full eligibility criteria
Who can join
  • Obesity type I (ITM \> 30 kg/m2) and/or
  • Prediabetes (fasting glucose levels 6,1 - 6,9 mmol/L)
What rules you out
  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • Izola, Slovenia

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 40 years to 65 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Izola, Slovenia. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.