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Antioxidant-rich Diet and Oxidative Stress in Healthy Preschoolers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04252105
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : July 1, 2020
Sponsor:
Collaborator:
University of Ljubljana, Biotechnical Faculty
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Oxidative Stress Dietary Supplement: Antioxidant Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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 : August 28, 2019
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Oxidative stress biomarkers [ Time Frame: 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,oʼ-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



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Ages Eligible for Study:   5 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04252105


Contacts
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Contact: Brigita Mali +38615229235 brigita.mali@kclj.si

Locations
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Slovenia
University of Ljubljana, Faculty of Medicine Recruiting
Ljubljana, Slovenia, 1000
Contact: Tadej Battelino, PhD    +386 1 522 92 35    tadej.battelino@mf.uni-lj.si   
Sub-Investigator: Maja Berlic         
Principal Investigator: Tadej Battelino, MD,PhD         
Sub-Investigator: Mojca Korosec, PhD         
Sponsors and Collaborators
University of Ljubljana, Faculty of Medicine
University of Ljubljana, Biotechnical Faculty
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Responsible Party: University of Ljubljana, Faculty of Medicine
ClinicalTrials.gov Identifier: NCT04252105    
Other Study ID Numbers: Ox-Stress-Preschool
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs