Antioxidant-rich Diet and Oxidative Stress in Healthy Preschoolers

NCT ID: NCT04252105

Last Updated: 2022-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-28

Study Completion Date

2020-12-30

Brief Summary

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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

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Conditions

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Oxidative Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Antioxidant rich diet

Group Type EXPERIMENTAL

Antioxidant

Intervention Type DIETARY_SUPPLEMENT

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

Regular diet

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Antioxidant

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

5 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Ljubljana

OTHER

Sponsor Role collaborator

University of Ljubljana, Faculty of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Ljubljana, Faculty of Medicine

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

References

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Berlic M, Korosec M, Remec ZI, Cuk V, Battelino T, Repic Lampret B. Effect of antioxidant-rich kindergarten meals on oxidative stress biomarkers in healthy 5-6-year-old children: a randomized controlled trial. Eur J Pediatr. 2024 Jul;183(7):3085-3094. doi: 10.1007/s00431-024-05576-6. Epub 2024 Apr 25.

Reference Type DERIVED
PMID: 38658398 (View on PubMed)

Other Identifiers

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Ox-Stress-Preschool

Identifier Type: -

Identifier Source: org_study_id

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