Clinical Trial of Crocus Kozanis Administration in Obese Children and Adolescents
NCT05572749 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75
Last updated 2024-02-08
Summary
The study aims to investigate possible effects of per os Crocus Kozanis administration in children and adolescents with obesity
Conditions
- PreDiabetes
- Obesity
- Dyslipidemias
Interventions
- 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.
- DIETARY_SUPPLEMENT
-
Placebo of Crocus Kozanis
Placebo of Crocus Kozanis
- DRUG
-
Metformin will be administered in a dosage of 1000mg per day. Metformin is a formally approved therapy for children with diabetes in Europe.
Sponsors & Collaborators
-
Aristotle University Of Thessaloniki
lead OTHER
Principal Investigators
-
Assimina Galli-Tsinopoulou, Professor · Aristotle University Of Thessaloniki
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 10 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-05-01
- Primary Completion
- 2023-09-30
- Completion
- 2023-09-30
Countries
- Greece
Study Locations
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