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Clinical Trials/NCT04252105
NCT04252105
Completed
Not Applicable

The Effect of an Antioxidant-rich Kindergarten Diet on Oxidative Stress in Healthy Preschool Children

University of Ljubljana, Faculty of Medicine1 site in 1 country57 target enrollmentAugust 28, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Oxidative Stress
Sponsor
University of Ljubljana, Faculty of Medicine
Enrollment
57
Locations
1
Primary Endpoint
Oxidative stress biomarkers
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Uncontrolled and prolonged oxidative stress plays an important role in the onset and progression of cardiovascular disease, hyperlipidemia, diabetes, and various cancers. Given that many diseases can start as early as childhood, eating patterns in childhood and preventing oxidative damage can have beneficial long-term health effects. Antioxidant-rich foods can slow down the progression of chronic diseases.

In Slovenian kindergartens (and schools) children consume up to 70% of their daily energy and nutritional needs, so what is offered to them is very important. This study will evaluate the hypothesis that providing an antioxidant-rich diet in kindergartens can result in the reduction of biomarkers of oxidative stress.

Registry
clinicaltrials.gov
Start Date
August 28, 2019
End Date
December 30, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Ljubljana, Faculty of Medicine
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • • Healthy children aged 5-6 who will attend the compulsory medical examination before entering primary school

Exclusion Criteria

  • • Children with chronic conditions (e.g. diabetes, asthma)
  • Children with allergies to food (e.g. gluten, egg, milk, lactose intolerance)

Outcomes

Primary Outcomes

Oxidative stress biomarkers

Time Frame: 2 weeks

Change in oxidative stress biomarkers of lipids (malondialdehyde (MDA), and four F2 - isoprostane isomers, namely 8 -iso-prostaglandin F2α (8-PGF2α), 11ß- prostaglandin F2α (11-PGF2α), 15 (R)-prostaglandin F2α (15-PGF 2α) and 8-iso, 15 prostaglandin F2α (8,15-PGF2α) ; proteins (o,o'-dityrosine (diY) and DNA 8-Hydroxy-2'-deoxyguanosine (8-OhdG) between day 1 and day 15 of the intervention diet, measured by HPLC-MS/MS

Study Sites (1)

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