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NCT04252105 Clinical Trial

Antioxidant-rich Diet and Oxidative Stress in Healthy Preschoolers

Oxidative Stress Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04252105
Other study ID # Ox-Stress-Preschool
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 28, 2019
Est. completion date December 30, 2020

Study information
Verified date March 2022
Source University of Ljubljana, Faculty of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 57
Est. completion date December 30, 2020
Est. primary completion date October 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 7 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Slovenia University of Ljubljana, Faculty of Medicine Ljubljana

Sponsors (2)
Lead Sponsor Collaborator
University of Ljubljana, Faculty of Medicine University of Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Oxidative stress biomarkers Change in oxidative stress biomarkers of lipids (malondialdehyde (MDA), and four F2 - isoprostane isomers, namely 8 -iso-prostaglandin F2a (8-PGF2a), 11ß- prostaglandin F2a (11-PGF2a), 15 (R)-prostaglandin F2a (15-PGF 2a) and 8-iso, 15 prostaglandin F2a (8,15-PGF2a) ; 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
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