Clinical Trial of Crocus Kozanis Administration in Obese Children and Adolescents

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

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

Conditions
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PreDiabetes, Obesity, Dyslipidemias

Intervention / Treatment
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* Dietary Supplement: Crocus Kozanis
* Dietary Supplement: Placebo of Crocus Kozanis
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>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<br>* In this study, intervention will be the administration of Crocus Kozanis dietary supplement. Crocus Kozanis is a herb which is cultivated in Kozani, Greece.<br>* Other names: Saffron Kozanis;Drug: Metformin<br>* Metformin will be administered in a dosage of 1000mg per day. Metformin is a formally approved therapy for children with diabetes in Europe.<br>* Other names: Metformin Hydrochloride;|
| Experimental: Arm 2<br>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<br>* In this study, intervention will be the administration of Crocus Kozanis dietary supplement. Crocus Kozanis is a herb which is cultivated in Kozani, Greece.<br>* Other names: Saffron Kozanis;Drug: Metformin<br>* Metformin will be administered in a dosage of 1000mg per day. Metformin is a formally approved therapy for children with diabetes in Europe.<br>* Other names: Metformin Hydrochloride;|
| Placebo Comparator: Arm 3<br>Participants of Arm 3 are going to be administered placebo (5ml twice per day) for 12 weeks | Dietary Supplement: Placebo of Crocus Kozanis<br>* Placebo of Crocus Kozanis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). |