Crocus Sativus Tepals Water Extract in Obesity and Prediabetes (ZAFRAN)

University of Primorska

Status and phase: Enrolling; Early Phase 1

Conditions: Prediabetes; Obesity & Overweight

Treatments: Biological: cold water; Biological: Crocus sativus tepals cold aqueous extract

Study type: Interventional

Funder types: Other

Identifiers

NCT07261475

ZAFRAN-2025

Details and patient eligibility

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Crocus sativus

Experimental group

Description:

Crocus sativus tepals cold aqueous extract

Treatment:

Biological: Crocus sativus tepals cold aqueous extract

water

Sham Comparator group

Description:

cold water

Treatment:

Biological: cold water