Antioxidant-rich Diet and Oxidative Stress in Healthy Preschoolers

Not Applicable

Completed

• Conditions: Oxidative Stress
• Interventions: Dietary Supplement: Antioxidant

• Registration Number: NCT04252105
• Lead Sponsor: University of Ljubljana, Faculty of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-28
• Study First Submitted: 2020-01-31
• Study First Submitted QC: 2020-01-31
• Study First Posted: 2020-02-05
• Primary Completion: 2020-10-30
• Study Completion: 2020-12-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antioxidant rich diet	Antioxidant	-

Primary Outcome Measures

Name	Time	Method
Oxidative stress biomarkers	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

Trial Locations

Locations (1)

University of Ljubljana, Faculty of Medicine; 🇸🇮 Ljubljana, Slovenia