Dyslipidemias, Obesity, PreDiabetes
Conditions
Brief summary
The study aims to investigate possible effects of per os Crocus Kozanis administration in children and adolescents with obesity
Interventions
DIETARY_SUPPLEMENTCrocus 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.
DIETARY_SUPPLEMENTPlacebo of Crocus Kozanis
Placebo of Crocus Kozanis
DRUGMetformin
Metformin will be administered in a dosage of 1000mg per day. Metformin is a formally approved therapy for children with diabetes in Europe.
Sponsors
Aristotle University Of Thessaloniki
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic control | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lipidemic profile | 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 |
Countries
Greece
Outcome results
None listed