Non Communicable DiseasesSportDietNCT06855979
The Impact of Dietary Intervention on Oxidative/antioxidant Markers and Gut Microbiota in Athletes
A study testing Food with high antioxidant potential in people with Non Communicable Diseases, run by Medical University of Bialystok at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Non Communicable Diseases
- What is being tested?
- Food with high antioxidant potential
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 15 Jan 2025to 15 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
The study concerns a 4-week dietary intervention. The intervention consisted of daily consumption of 1 bar weighing 50 g, containing nuts and dried fruits with high antioxidant potential. The study included a group of 50 women and men, healthy athletes (cyclists, long-distance runners and triathletes). A 3-day, 24-hour dietary interview was conducted before and after the dietary intervention. Then, using the Dieta 6.0 computer program, the energy and nutrient contents in the diet were estimated. In addition, adherence to the dietary intervention was assessed using a survey questionnaire. Before and after the dietary intervention, oxidative-antioxidant markers were determined in the blood of the subjects (oxidative stress, antioxidant potential, concentration of antioxidant enzymes: glutathione peroxidase, superoxide dismutase, catalase) using ready-made kits. Moreover, changes in the intestinal microbiome were assessed in feces before and after the dietary intervention. Additionally, height and weight were measured before and after the intervention to calculate body mass index (BMI). The study will help answer the question of whether dietary intervention using foods with high antioxidant potential can influence changes in oxidative-antioxidant markers in the blood, intestinal microbiome and body weight of study participants.
- Conditions
- Non Communicable Diseases
- Being tested
- Food with high antioxidant potential
- Keywords
- sport, cardiovascular disease, antioxidant stress
- Medical subject headings
- Noncommunicable Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food with high antioxidant potentialOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Food with high antioxidant potential |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 weeks
Secondary outcomes (3)
Assessment of dietary nutrients before and after dietary intervention
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.
Measured: 4 weeks
Body weight assessment before and after dietary intervention
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.
Measured: 4 weeks
Measuring the height of study participants
Height was determined in centimeters using a measuring tape with an accuracy of 1 cm.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start15 Jan 2025
- Primary completion15 Feb 2025
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Communicable DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malgorzata E Zujko, Prof., Principal investigator, Medical University of Bialystok, Jana Kilinskiego 1, 15-089 Bialystok
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855979
- Sponsor's protocol ID
- APK.002.405.2024
- Other IDs
- SKN/SP/601112/2024, B.SUB.25.207
- Acronym
- SportDiet
- Status last verified
- Feb 2025
- First submitted
- 20 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research results will be published in a scientific journal. Detailed data of respondents are not made available due to personal data protection.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Dietary Intervention Using Innovative Food with High Antioxidant Potential on Oxidative/antioxidant Markers in Blood and Gut Microbiota in Athletes
- ClinicalTrials.gov ID
- NCT06855979
- Acronym / sponsor ID
- SportDiet / APK.002.405.2024
- Conditions
- Non Communicable Diseases
- Keywords
- sport, cardiovascular disease, antioxidant stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study concerns a 4-week dietary intervention. The intervention consisted of daily consumption of 1 bar weighing 50 g, containing nuts and dried fruits with high antioxidant potential. The study included a group of 50 women and men, healthy athletes (cyclists, long-distance runners and triathletes). A 3-day, 24-hour dietary interview was conducted before and after the dietary intervention. Then, using the Dieta 6.0 computer program, the energy and nutrient contents in the diet were estimated. In addition, adherence to the dietary intervention was assessed using a survey questionnaire. Before and after the dietary intervention, oxidative-antioxidant markers were determined in the blood of the subjects (oxidative stress, antioxidant potential, concentration of antioxidant enzymes: glutathione peroxidase, superoxide dismutase, catalase) using ready-made kits. Moreover, changes in the intestinal microbiome were assessed in feces before and after the dietary intervention. Additionally, height and weight were measured before and after the intervention to calculate body mass index (BMI). The study will help answer the question of whether dietary intervention using foods with high antioxidant potential can influence changes in oxidative-antioxidant markers in the blood, intestinal microbiome and body weight of study participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxidative-antioxidant markers in blood and gut microbiota | Experimental | Other: Food with high antioxidant potentialBefore 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food with high antioxidant potentialThe 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. | Other | Oxidative-antioxidant markers in blood and gut microbiota |
Primary outcome
Change in antioxidant potential after dietary intervention
Time frame: 4 weeks
Before and after the dietary intervention, the antioxidant potential in the blood was determined using the ABTS method.
Change in gut microbiota after dietary intervention
Time frame: 4 weeks
The gut microbiota in feces was determined before and after the dietary intervention in a hospital laboratory.
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.
Change in blood glutathione peroxidase concentration after dietary intervention
Time frame: 4 weeks
Before and after the dietary intervention, the concentration of glutathione peroxidase enzyme in blood was assessed using ready-made laboratory kits.
Change in superoxide dismutase concentration after dietary intervention
Time frame: 4 weeks
Before and after the dietary intervention, the concentration of superoxide dismutase enzyme in blood was assessed using ready-made laboratory kits.
Change in catalase concentrations after dietary intervention
Time frame: 4 weeks
Before and after the dietary intervention, the concentration of catalase enzyme in blood was assessed using ready-made laboratory kits.
Change in oxidative stress after dietary intervention
Time frame: 4 weeks
Before and after the dietary intervention, the oxidative stress in blood was assessed using ready-made laboratory kits.
3 secondary outcomes
Assessment of dietary nutrients before and after dietary intervention
Time frame: 4 weeks
Body weight assessment before and after dietary intervention
Time frame: 4 weeks
Measuring the height of study participants
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Individual participant dataSharing planned: Yes. The research results will be published in a scientific journal. Detailed data of respondents are not made available due to personal data protection.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malgorzata E Zujko, Prof. principal investigator
Medical University of Bialystok, Jana Kilinskiego 1, 15-089 Bialystok
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food with high antioxidant potential in people with Non Communicable Diseases, run by Medical University of Bialystok at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in antioxidant potential after dietary intervention (time frame: 4 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.