Clinical Trial of Crocus Kozanis Administration in Obese Children and Adolescents

NCT05572749 | Completed

• 1 other identifier: Crocus Kozanis & Child Obesity
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

PreDiabetes; Obesity; Dyslipidemias

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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).

Study Arms (3)

Arm 1

EXPERIMENTAL

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; Drug: Metformin

Arm 2

EXPERIMENTAL

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; Drug: Metformin

Arm 3

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo of Crocus Kozanis

Interventions

Crocus Kozanis DIETARY_SUPPLEMENT

In this study, intervention will be the administration of Crocus Kozanis dietary supplement. Crocus Kozanis is a herb which is cultivated in Kozani, Greece.

Also known as: Saffron, Crocus Sativus, Saffron Kozanis

Arm 1; Arm 2

Placebo of Crocus Kozanis DIETARY_SUPPLEMENT

Placebo of Crocus Kozanis

Arm 3

Metformin DRUG

Metformin will be administered in a dosage of 1000mg per day. Metformin is a formally approved therapy for children with diabetes in Europe.

Also known as: Metformin Hydrochloride

Arm 1; Arm 2

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Overt diabetes (any type)
• Diagnosis of any chronic disease
• Previous use of dietary supplement with Crocus or Crocus Sativus
• Administration of chronic medication

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Unit of Paediatric Endocrinology and Metabolism, 2nd Department of Paediatrics, AHEPA University Hospital

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Prediabetic State; Obesity; Dyslipidemias

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Assimina Galli-Tsinopoulou, Professor

  Aristotle University Of Thessaloniki

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Paediatrics-Paediatric Endocrinology

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: October 10, 2022
• Study Start: May 1, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)