Clinical Trial of Crocus Kozanis Administration in Obese Children and Adolescents

Aristotle University Of Thessaloniki75 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

PreDiabetes Obesity Dyslipidemias

Interventions

Crocus KozanisDIETARY_SUPPLEMENT

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 KozanisDIETARY_SUPPLEMENT

Placebo of Crocus Kozanis

MetforminDRUG

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

Eligibility

Sex: ALLMin age: 10 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Thessaloniki, Greece

Outcomes

Primary Outcomes

Glycemic control

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 Outcomes

Lipidemic profile

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).

Data from ClinicalTrials.gov

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