- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06855979
The Impact of Dietary Intervention on Oxidative/antioxidant Markers and Gut Microbiota in Athletes (SportDiet)
The Impact of Dietary Intervention Using Innovative Food with High Antioxidant Potential on Oxidative/antioxidant Markers in Blood and Gut Microbiota in Athletes
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Białystok, Poland, 15-089
- Medical University of Bialystok
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Oxidative-antioxidant markers in blood and gut microbiota
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in antioxidant potential after dietary intervention
Time Frame: 4 weeks
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Before and after the dietary intervention, the antioxidant potential in the blood was determined using the ABTS method.
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4 weeks
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Change in gut microbiota after dietary intervention
Time Frame: 4 weeks
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The gut microbiota in feces was determined before and after the dietary intervention in a hospital laboratory.
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4 weeks
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Assessment of dietary intervention
Time Frame: 4 weeks
|
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.
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4 weeks
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Change in blood glutathione peroxidase concentration after dietary intervention
Time Frame: 4 weeks
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Before and after the dietary intervention, the concentration of glutathione peroxidase enzyme in blood was assessed using ready-made laboratory kits.
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4 weeks
|
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Change in superoxide dismutase concentration after dietary intervention
Time Frame: 4 weeks
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Before and after the dietary intervention, the concentration of superoxide dismutase enzyme in blood was assessed using ready-made laboratory kits.
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4 weeks
|
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Change in catalase concentrations after dietary intervention
Time Frame: 4 weeks
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Before and after the dietary intervention, the concentration of catalase enzyme in blood was assessed using ready-made laboratory kits.
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4 weeks
|
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Change in oxidative stress after dietary intervention
Time Frame: 4 weeks
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Before and after the dietary intervention, the oxidative stress in blood was assessed using ready-made laboratory kits.
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of dietary nutrients before and after dietary intervention
Time Frame: 4 weeks
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Before and after the dietary intervention, a 3-day, 24-hour interview was conducted regarding the consumption of products and dishes during the day.
Using the Diet 6.0 computer program, the content of individual nutrients in the diet and energy of diet were determined.
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4 weeks
|
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Body weight assessment before and after dietary intervention
Time Frame: 4 weeks
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The change in body weight of the subjects before and after the dietary intervention was determined using a scale in kilograms with an accuracy of 100 g.
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4 weeks
|
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Measuring the height of study participants
Time Frame: 4 weeks
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Height was determined in centimeters using a measuring tape with an accuracy of 1 cm.
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4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Malgorzata E Zujko, Prof., Medical University of Bialystok, Jana Kilinskiego 1, 15-089 Bialystok
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APK.002.405.2024
- SKN/SP/601112/2024 (Other Grant/Funding Number: Ministry of Science and Higher Education in Poland)
- B.SUB.25.207 (Other Grant/Funding Number: Medical University of Bialystok)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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