NCT06855979

Brief Summary

During intense physical exercise, there is an overproduction of reactive oxygen species, which leads to oxidative stress and reduced training and sports performance, as well as the development of chronic diseases. Eating foods with a high content of bioactive ingredients and high antioxidant potential can alleviate the negative effects caused by reactive oxygen species and improve the state of intestinal microflora. The aim of these interventional studies was to determine whether daily consumption of foods with high antioxidant potential, including fruit and nut bars, for a period of 1 month would reduce oxidative stress in athletes during competition and positively change the intestinal microflora.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 4, 2025

Completed
Last Updated

March 4, 2025

Status Verified

February 1, 2025

Enrollment Period

1 month

First QC Date

February 20, 2025

Last Update Submit

February 25, 2025

Conditions

Keywords

sportcardiovascular diseaseantioxidant stress

Outcome Measures

Primary Outcomes (7)

  • Change in antioxidant potential after dietary intervention

    Before and after the dietary intervention, the antioxidant potential in the blood was determined using the ABTS method.

    4 weeks

  • Change in gut microbiota after dietary intervention

    The gut microbiota in feces was determined before and after the dietary intervention in a hospital laboratory.

    4 weeks

  • Assessment of dietary intervention

    The dietary intervention lasted 4 weeks. The subjects received one bar a day weighing 50 g, containing nuts and dried fruits with high antioxidant potential and high polyphenol content. After the dietary intervention, the participants completed a survey containing questions about compliance with the recommendations of the dietary intervention.

    4 weeks

  • Change in blood glutathione peroxidase concentration after dietary intervention

    Before and after the dietary intervention, the concentration of glutathione peroxidase enzyme in blood was assessed using ready-made laboratory kits.

    4 weeks

  • Change in superoxide dismutase concentration after dietary intervention

    Before and after the dietary intervention, the concentration of superoxide dismutase enzyme in blood was assessed using ready-made laboratory kits.

    4 weeks

  • Change in catalase concentrations after dietary intervention

    Before and after the dietary intervention, the concentration of catalase enzyme in blood was assessed using ready-made laboratory kits.

    4 weeks

  • Change in oxidative stress after dietary intervention

    Before and after the dietary intervention, the oxidative stress in blood was assessed using ready-made laboratory kits.

    4 weeks

Secondary Outcomes (3)

  • Assessment of dietary nutrients before and after dietary intervention

    4 weeks

  • Body weight assessment before and after dietary intervention

    4 weeks

  • Measuring the height of study participants

    4 weeks

Study Arms (1)

Oxidative-antioxidant markers in blood and gut microbiota

EXPERIMENTAL

Before and after the 1-month dietary intervention, the following markers will be determined in the blood: antioxidant potential, antioxidant enzymes, oxidative stress. Moreover, the intestinal microbiota will be determined before and after the intervention.

Other: Food with high antioxidant potential

Interventions

The dietary intervention using fruit and nut bars with high antioxidant activity will last 1 month. Before and after the procedure, oxidative-antioxidant markers in the blood and intestinal microflora in the stool will be determined.

Oxidative-antioxidant markers in blood and gut microbiota

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy men and women with high physical activity (triathletes, cyclists, long-distance runners), not taking medications for chronic diseases, age 20-50 years, men and women.

You may not qualify if:

  • occurence of chronic diseases (e.g. hypertension, diabetes, cancer, thyroid diseases, neurodegenerative diseases), taking medications for chronic diseases, age\<20 and \>50 years, low physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Bialystok

Bialystok, 15-089, Poland

Location

MeSH Terms

Conditions

Noncommunicable DiseasesCardiovascular Diseases

Interventions

Food

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Malgorzata E Zujko, Prof.

    Medical University of Bialystok, Jana Kilinskiego 1, 15-089 Bialystok

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2025

First Posted

March 4, 2025

Study Start

January 15, 2025

Primary Completion

February 15, 2025

Study Completion

February 15, 2025

Last Updated

March 4, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

The research results will be published in a scientific journal. Detailed data of respondents are not made available due to personal data protection.

Shared Documents
CSR
Time Frame
The clinical trial report will be published in scientific journals after the study is completed.
Access Criteria
Additional information can be obtained by writing to the principal investigator's address: malgorzata.zujko@umb.edu.pl.

Locations