Clinical Trial of Crocus Kozanis Administration in Obese Children and Adolescents

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05572749
• Other study ID #: Crocus Kozanis & Child Obesity
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: February 2024
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias
• Obesity
• PreDiabetes

Intervention

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.
• Placebo of Crocus Kozanis
Placebo of Crocus 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.

Locations

Country	Name	City	State
Greece	Unit of Paediatric Endocrinology and Metabolism, 2nd Department of Paediatrics, AHEPA University Hospital	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic control	Glycemic control will be assessed with glycated hemoglobin (?bA1c%) 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	Lipidemic profile	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).