Antioxidant-rich Diet and Oxidative Stress in Healthy Preschoolers

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.

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Key information

Conditions

Oxidative Stress

Age range

5 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Ljubljana, Faculty of Medicine

Ljubljana, 1000, Slovenia

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

Antioxidant

Dietary Supplement

Antioxidant-rich diet (added selected types of fruits, vegetables, nuts, cereals and oils)

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

Sponsors and collaborators

Lead sponsor

University of Ljubljana, Faculty of Medicine

Other

Collaborators

University of Ljubljana

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Feb 5, 2020
Registry last updated: Mar 15, 2022

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.

Published trials that share one or more normalized conditions with this study.

Completed