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Clinical Trial of Crocus Kozanis Administration in Obese Children and Adolescents

Primary Purpose

PreDiabetes, Obesity, Dyslipidemias

Status

Recruiting

Phase

Not Applicable

Locations

Greece

Study Type

Interventional

Intervention

Crocus Kozanis

Placebo of Crocus Kozanis

Metformin

About this trial

This is an interventional treatment trial for PreDiabetes

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Unit of Paediatric Endocrinology and Metabolism, 2nd Department of Paediatrics, AHEPA University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

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.

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.

Participants of Arm 3 are going to be administered placebo (5ml twice per day) for 12 weeks

Outcomes

Primary Outcome Measures

Glycemic control

Glycemic control will be assessed with glycated hemoglobin (ΗbA1c%) and/or oral glucose tolerance test (OGTT)

Secondary Outcome Measures

Lipidemic profile

Lipidemic profile will be assessed with levels of cholesterol, triglycerides, HDL and LDL in fasting state

Full Information

NCT ID

NCT05572749

First Posted

September 13, 2022

Last Updated

July 20, 2023

Sponsor

Aristotle University Of Thessaloniki

1. Study Identification

Unique Protocol Identification Number

NCT05572749

Brief Title

Clinical Trial of Crocus Kozanis Administration in Obese Children and Adolescents

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 1, 2021 (Actual)

Primary Completion Date

September 30, 2023 (Anticipated)

Study Completion Date

September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aristotle University Of Thessaloniki

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

PreDiabetes, Obesity, Dyslipidemias

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

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.

Arm Title

Arm 2

Arm Type

Experimental

Arm Description

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.

Arm Title

Arm 3

Arm Type

Placebo Comparator

Arm Description

Participants of Arm 3 are going to be administered placebo (5ml twice per day) for 12 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

Crocus Kozanis

Other Intervention Name(s)

Saffron, Crocus Sativus, Saffron Kozanis

Intervention Description

In this study, intervention will be the administration of Crocus Kozanis dietary supplement. Crocus Kozanis is a herb which is cultivated in Kozani, Greece.

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo of Crocus Kozanis

Intervention Description

Placebo of Crocus Kozanis

Intervention Type

Drug

Intervention Name(s)

Metformin

Other Intervention Name(s)

Metformin Hydrochloride

Intervention Description

Metformin will be administered in a dosage of 1000mg per day. Metformin is a formally approved therapy for children with diabetes in Europe.

Primary Outcome Measure Information:

Title

Glycemic control

Description

Glycemic control will be assessed with glycated hemoglobin (ΗbA1c%) and/or oral glucose tolerance test (OGTT)

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).

Secondary Outcome Measure Information:

Title

Lipidemic profile

Description

Lipidemic profile will be assessed with levels of cholesterol, triglycerides, HDL and LDL in fasting state

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).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Assimina Galli-Tsinopoulou, Professor

Phone

+302310994801

agalli@auth.gr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Assimina Galli-Tsinopoulou, Professor

Organizational Affiliation

Aristotle University Of Thessaloniki

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Thessaloniki

Country

Greece

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Assimina Galli-Tsinopoulou, Professor

Phone

+302310994801

agalli@auth.gr

First Name & Middle Initial & Last Name & Degree

Eleni Kotanidou, PhD

Phone

+302310994801

epkotanidou@auth.gr

First Name & Middle Initial & Last Name & Degree

Assimina Galli-Tsinopoulou, Professor

First Name & Middle Initial & Last Name & Degree

Eleni P Kotanidou, PhD

First Name & Middle Initial & Last Name & Degree

Vassiliki Regina Tsinopoulou, MSc

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Clinical Trial of Crocus Kozanis Administration in Obese Children and Adolescents

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