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
• Status: Completed
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Oxidative Stress

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