Clinical Trial of Crocus Kozanis Administration in Obese Children and Adolescents

Not Applicable

Completed

• Conditions: PreDiabetes; Obesity; Dyslipidemias
• Interventions: Dietary Supplement: Crocus Kozanis; Dietary Supplement: Placebo of Crocus Kozanis; Drug: Metformin

• Registration Number: NCT05572749
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-01
• Study First Submitted: 2022-09-13
• Study First Submitted QC: 2022-10-06
• Study First Posted: 2022-10-10
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	Crocus Kozanis	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.
Arm 2	Crocus Kozanis	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.
Arm 3	Placebo of Crocus Kozanis	Participants of Arm 3 are going to be administered placebo (5ml twice per day) for 12 weeks
Arm 1	Metformin	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.
Arm 2	Metformin	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Unit of Paediatric Endocrinology and Metabolism, 2nd Department of Paediatrics, AHEPA University Hospital; 🇬🇷 Thessaloniki, Greece