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Completed

NCT Number: NCT05572749

Clinical Trial of Crocus Kozanis Administration in Obese Children and Adolescents

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

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Key information

Conditions

PreDiabetes Body Weight Diabetes Mellitus Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Prediabetic State Signs and Symptoms

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Thessaloniki, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Saffron, Crocus Sativus, Saffron Kozanis

Placebo of Crocus Kozanis

Dietary Supplement

Placebo of Crocus Kozanis

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.

Other names: Metformin Hydrochloride

Primary outcomes

  1. Glycemic control

    Time frame: 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 outcomes

  1. Lipidemic profile

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study title

Double-blind Randomized Cross-over Clinical Trial of Crocus Kozanis Administration in Obese Children and Adolescents

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 10, 2022
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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