Clinical Trial of Crocus Kozanis Administration in Obese Children and Adolescents

February 7, 2024 updated by: Assimina Galli-Tsinopoulou, Aristotle University Of Thessaloniki

Double-blind Randomized Cross-over Clinical Trial of Crocus Kozanis Administration in Obese Children and Adolescents

The study aims to investigate possible effects of per os Crocus Kozanis administration in children and adolescents with obesity

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Assimina Galli-Tsinopoulou, Professor
  • Phone Number: +302310994801
  • Email: agalli@auth.gr

Study Locations

  • Greece
      • Thessaloniki, Greece
        • Unit of Paediatric Endocrinology and Metabolism, 2nd Department of Paediatrics, AHEPA University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age above 10 year-old
  • Diagnosis of Obesity according to International Obesity Task Force Criteria
  • Presence of impaired glucose tolerance and/or impaired fasting glucose

Exclusion Criteria:

  • Overt diabetes (any type)
  • Diagnosis of any chronic disease
  • Previous use of dietary supplement with Crocus or Crocus Sativus
  • Administration of chronic medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1
Participants of Arm 1 are going to be administered Crocus Kozanis for 12 weeks (30mg twice per day), wash-out period for 12 weeks and metformin (1000mg once per day) for 12 weeks.
Dietary supplement: Crocus Kozanis
In this study, intervention will be the administration of Crocus Kozanis dietary supplement. Crocus Kozanis is a herb which is cultivated in Kozani, Greece.
Other Names:
  • Saffron
  • Crocus Sativus
  • Saffron Kozanis
Drug: Metformin
Metformin will be administered in a dosage of 1000mg per day. Metformin is a formally approved therapy for children with diabetes in Europe.
Other Names:
  • Metformin Hydrochloride
Experimental: Arm 2
Participants of Arm 2 are going to be administered metformin (1000mg once per day) for 12 weeks, wash-out period for 12 weeks and Crocus Kozanis (30mg twice per day) for 12 weeks.
Dietary supplement: Crocus Kozanis
In this study, intervention will be the administration of Crocus Kozanis dietary supplement. Crocus Kozanis is a herb which is cultivated in Kozani, Greece.
Other Names:
  • Saffron
  • Crocus Sativus
  • Saffron Kozanis
Drug: Metformin
Metformin will be administered in a dosage of 1000mg per day. Metformin is a formally approved therapy for children with diabetes in Europe.
Other Names:
  • Metformin Hydrochloride
Placebo Comparator: Arm 3
Participants of Arm 3 are going to be administered placebo (5ml twice per day) for 12 weeks
Dietary supplement: Placebo of Crocus Kozanis
Placebo of Crocus Kozanis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Glycemic control
Time Frame: Glycemic control will be assessed for each participant at the beginning of the study and thereafter every 12 weeks, up to 9 months (week 0, week 12, week 24, week 36).
Glycemic control will be assessed with glycated hemoglobin (ΗbA1c%) and/or oral glucose tolerance test (OGTT)
Glycemic control will be assessed for each participant at the beginning of the study and thereafter every 12 weeks, up to 9 months (week 0, week 12, week 24, week 36).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lipidemic profile
Time Frame: Lipidemic profile will be assessed for each participant at the beginning of the study and thereafter every 12 weeks, up to 9 months (week 0, week 12, week 24, week 36).
Lipidemic profile will be assessed with levels of cholesterol, triglycerides, HDL and LDL in fasting state
Lipidemic profile will be assessed for each participant at the beginning of the study and thereafter every 12 weeks, up to 9 months (week 0, week 12, week 24, week 36).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aristotle University Of Thessaloniki

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Assimina Galli-Tsinopoulou, Professor, Aristotle University Of Thessaloniki

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Crocus Kozanis & Child Obesity

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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