Antioxidant-rich Diet and Oxidative Stress in Healthy Preschoolers

• Sponsor: University of Ljubljana, Faculty of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT04252105
• Collaborator: University of Ljubljana (Other)
• Enrollment: 57
• Location: 1
• Arms: 2
• Actual Duration (Months): 16.1
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oxidative Stress	Dietary Supplement: Antioxidant	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 57 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: The Effect of an Antioxidant-rich Kindergarten Diet on Oxidative Stress in Healthy Preschool Children
• Actual Study Start Date: Aug 28, 2019
• Actual Primary Completion Date: Oct 30, 2020
• Actual Study Completion Date: Dec 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Antioxidant rich diet	Dietary Supplement: Antioxidant; Antioxidant-rich diet (added selected types of fruits, vegetables, nuts, cereals and oils)
No Intervention: Regular diet

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 7 Years
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Ljubljana, Faculty of Medicine	Ljubljana		Slovenia	1000

Sponsors and Collaborators

• University of Ljubljana, Faculty of Medicine
• University of Ljubljana

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Ljubljana, Faculty of Medicine
• ClinicalTrials.gov Identifier: NCT04252105
• Other Study ID Numbers: Ox-Stress-Preschool
• First Posted: Feb 5, 2020
• Last Update Posted: Mar 15, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Antioxidants

Study Results

No Results Posted as of Mar 15, 2022