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Antioxidant-rich Diet and Oxidative Stress in Healthy Preschoolers

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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

Tracking Information
First Submitted Date  ICMJE January 31, 2020
First Posted Date  ICMJE February 5, 2020
Last Update Posted Date July 1, 2020
Actual Study Start Date  ICMJE August 28, 2019
Estimated Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antioxidant-rich Diet and Oxidative Stress in Healthy Preschoolers
Official Title  ICMJE The Effect of an Antioxidant-rich Kindergarten Diet on Oxidative Stress in Healthy Preschool Children
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Oxidative Stress
Intervention  ICMJE Dietary Supplement: Antioxidant
Antioxidant-rich diet (added selected types of fruits, vegetables, nuts, cereals and oils)
Study Arms  ICMJE
  • Experimental: Antioxidant rich diet
    Intervention: Dietary Supplement: Antioxidant
  • No Intervention: Regular diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 31, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2020
Estimated Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 7 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Brigita Mali +38615229235 brigita.mali@kclj.si
Listed Location Countries  ICMJE Slovenia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04252105
Other Study ID Numbers  ICMJE Ox-Stress-Preschool
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Ljubljana, Faculty of Medicine
Study Sponsor  ICMJE University of Ljubljana, Faculty of Medicine
Collaborators  ICMJE University of Ljubljana, Biotechnical Faculty
Investigators  ICMJE Not Provided
PRS Account University of Ljubljana, Faculty of Medicine
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP