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Antioxidant-rich Diet and Oxidative Stress in Healthy Preschoolers

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04252105
Enrollment
57
Registered
2020-02-05
Start date
2019-08-28
Completion date
2020-12-30
Last updated
2022-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oxidative Stress

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.

Interventions

DIETARY_SUPPLEMENTAntioxidant

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

Sponsors

University of Ljubljana
CollaboratorOTHER
University of Ljubljana, Faculty of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 7 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Oxidative stress biomarkers2 weeksChange 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

Countries

Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026