Antioxidant-rich Diet and Oxidative Stress in Healthy Preschoolers
The Effect of an Antioxidant-rich Kindergarten Diet on Oxidative Stress in Healthy Preschool Children
1 other identifier
interventional
57
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 28, 2019
CompletedFirst Submitted
Initial submission to the registry
January 31, 2020
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedMarch 15, 2022
March 1, 2022
1.2 years
January 31, 2020
March 14, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Oxidative stress biomarkers
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
2 weeks
Study Arms (2)
Antioxidant rich diet
EXPERIMENTALRegular diet
NO INTERVENTIONInterventions
Antioxidant-rich diet (added selected types of fruits, vegetables, nuts, cereals and oils)
Eligibility Criteria
You may qualify if:
- Healthy children aged 5-6 who will attend the compulsory medical examination before entering primary school
You may not qualify if:
- Children with chronic conditions (e.g. diabetes, asthma)
- Children with allergies to food (e.g. gluten, egg, milk, lactose intolerance)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Ljubljana, Faculty of Medicine
Ljubljana, 1000, Slovenia
Related Publications (1)
Berlic M, Korosec M, Remec ZI, Cuk V, Battelino T, Repic Lampret B. Effect of antioxidant-rich kindergarten meals on oxidative stress biomarkers in healthy 5-6-year-old children: a randomized controlled trial. Eur J Pediatr. 2024 Jul;183(7):3085-3094. doi: 10.1007/s00431-024-05576-6. Epub 2024 Apr 25.
PMID: 38658398DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2020
First Posted
February 5, 2020
Study Start
August 28, 2019
Primary Completion
October 30, 2020
Study Completion
December 30, 2020
Last Updated
March 15, 2022
Record last verified: 2022-03