Clinical Trial of Crocus Kozanis Administration in Obese Children and Adolescents

Aristotle University Of Thessaloniki

Status: Completed

Conditions: Dyslipidemias; Obesity; PreDiabetes

Treatments: Dietary Supplement: Placebo of Crocus Kozanis; Drug: Metformin; Dietary Supplement: Crocus Kozanis

Study type: Interventional

Funder types: Other

Identifiers

NCT05572749

Crocus Kozanis & Child Obesity

Details and patient eligibility

About

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

Enrollment: 75 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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75 participants in 3 patient groups, including a placebo group

Arm 1

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Crocus Kozanis

Drug: Metformin

Arm 2

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Crocus Kozanis

Drug: Metformin

Arm 3

Placebo Comparator group

Description:

Participants of Arm 3 are going to be administered placebo (5ml twice per day) for 12 weeks

Treatment:

Dietary Supplement: Placebo of Crocus Kozanis