Inflammatory ResponseNCT05242978
Acute Impact of Different Foods and Beverages on Exercise Induced Oxidative Stress and Inflammation
A study testing Nutrition in people with Inflammatory Response and Oxidative Stress, run by University of Vienna at 1 site in Austria.
Trial summary
The aim of this research project is to explore the acute impact of specific foods and beverages, which have been shown to be associated with inflammatory processes, mainly in epidemiological studies, on inflammatory and oxidative stress parameters in healthy humans following a high intensity physical workout. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Response, Oxidative Stress, Oxidative Stress Induction
- What is being tested?
- Nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteAustria
- Study dates
- 17 May 2022to 30 Apr 2024
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female human subjects
- aged 18-40 years
- no chronical diseases
- not more than 120 minutes of physical activity per week
- no regular resistance training within the past 6 months
- BMI 18.5 - 24.99 kg/m²
- body fat percentage of at least 20%
Who cannot join
- contraindications against physical activity
- anemia
- fructose or lactose intolerance
- smoking
- medications with influence on ROS levels or inflammation
- allergy or intolerance against intervention food/beverages.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this research project is to explore the acute impact of specific foods and beverages, which have been shown to be associated with inflammatory processes, mainly in epidemiological studies, on inflammatory and oxidative stress parameters in healthy humans following a high intensity physical workout.
Read the detailed description
The aim of this research project is to explore the acute impact of specific foods and beverages, which have been shown to be associated with inflammatory processes, mainly in epidemiological studies, on inflammatory and oxidative stress parameters in healthy humans following a high intensity physical workout. The choice of food will mainly be based on the food groups from the Empirical Dietary Inflammatory Index. For that purpose, forty-two healthy volunteers will be recruited to perform several interventions in order to assess the impact of different nutrient groups or single- foods on oxidative and inflammatory markers. They will be divided into two groups (beverage consumption, n=20 \& plantbased foods, n=22). The intense physical activity serves to induce a physiological stress response in the body, known to be accompanied by an increase in oxidative and inflammatory stress parameters. The idea is that anti- inflammatory or antioxidant nutrients could potentially attenuate this stress response in dependence on their anti- inflammatory or antioxidant potential. The operability of this concept has already been tested. The main benefit of this approach is to get a deeper insight into short term effects of single foods or beverages on inflammatory and prooxidative processes in humans by using short term intense physical activity as a stress model. One major practical aspect of this approach is to assess dietary components with respect to their pro- or anti-inflammatory-/oxidative stress potential regarding e.g. non-communicable diseases such as type 2 diabetes, coronary heart disease or the metabolic syndrome. Furthermore, it could help to reduce inflammation or oxidative stress during or following high intense physical exercise in order to reduce the stress response during training or competition in order to enhance regeneration and to foster the training gain in sports.
- Being tested
- Nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NutritionOther
acute single dose nutrition intervention
| Study group | Role | What they receive |
|---|---|---|
| Impact of GT, coffee, OJ, PGJ, milk, SSB on exercise induced oxidative stress&inflammation | Experimental | single consumption of one cup of green tea (GT), coffee, orange juice (OJ), pomegranate juice (PGJ), milk and sugar sweetened beverage (SSB) 2 hours prior to a 30-min- HIIT resistance circuit exercise in healthy human subjects Receives: Other: Nutrition |
| Impact of choc, bcc, fl-oil, blueb., r&w bread on exercise induced oxidative stress&inflammation | Experimental | single consumption of one proportion of dark chocolate (choc), broccoli (bcc), flaxseed oil, blueberries, white bread and whole grain bread (r = refined \& w = whole grain) 2 hours prior to a 30-min-HIIT resistance circuit exercise in healthy human subjects Receives: Other: Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
ROS change
ROS (change from baseline = after overnight fasting to post exercise (=after 2.5 hours)
Measured: change from baseline to 2.5 hours
IL-6 change
IL-6 (change from baseline = after overnight fasting to post exercise (=after 2.5 hours)
Measured: change from baseline to 2.5 hours
Secondary outcomes (8)
estradiol
17-beta-estradiol
Measured: baseline
DNA damage (comet assay
comet assay - wholeblood
Measured: change from baseline to 2.5 hours
MDA change
MDA (change from baseline = after overnight fasting to post exercise (=after 2.5 hours)
Measured: change from baseline to 2.5 hours
hs-CRP change
hs-CRP (change from baseline = after overnight fasting to post exercise (=after 2.5 hours)
Measured: change from baseline to 2.5 hours
FRAP
Ferric Reducing Antioxidant Power Assay
Measured: change from baseline to 2.5 hours
Polyphenol Content
Polyphenol Content Plasma
Measured: change from baseline to 2.5 hours
Lipidomics
oxLDL
Measured: change from baseline to 2.5 hours
Protein Carbonyls
Protein Carbonyl Assay
Measured: change from baseline to 2.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start17 May 2022
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory ResponseStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- acute consumption of anti- and pro- inflammatory foods (n=22) and beverages (n=20) 2 hour prior to intense physical activity in healthy female subjects (in total 42 subjects)
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel König, University of Vienna
- Investigators
- Markus Gassner, MSc, Principal investigator, University AssistantDaniel König, Univ Prof, Study director, Professor of sports nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242978
- Sponsor's protocol ID
- 2021-00743
- Status last verified
- Nov 2024
- First submitted
- 26 Jan 2022
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Impact of Different Foods and Beverages on Exercise Induced Oxidative Stress and Inflammation
- ClinicalTrials.gov ID
- NCT05242978
- Acronym / sponsor ID
- 2021-00743
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of ViennaUniversity, hospital or other
- Study start
- 17 May 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 16 Feb 2022 (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.
The aim of this research project is to explore the acute impact of specific foods and beverages, which have been shown to be associated with inflammatory processes, mainly in epidemiological studies, on inflammatory and oxidative stress parameters in healthy humans following a high intensity physical workout.
Detailed description
The aim of this research project is to explore the acute impact of specific foods and beverages, which have been shown to be associated with inflammatory processes, mainly in epidemiological studies, on inflammatory and oxidative stress parameters in healthy humans following a high intensity physical workout. The choice of food will mainly be based on the food groups from the Empirical Dietary Inflammatory Index. For that purpose, forty-two healthy volunteers will be recruited to perform several interventions in order to assess the impact of different nutrient groups or single- foods on oxidative and inflammatory markers. They will be divided into two groups (beverage consumption, n=20 \& plantbased foods, n=22). The intense physical activity serves to induce a physiological stress response in the body, known to be accompanied by an increase in oxidative and inflammatory stress parameters. The idea is that anti- inflammatory or antioxidant nutrients could potentially attenuate this stress response in dependence on their anti- inflammatory or antioxidant potential. The operability of this concept has already been tested. The main benefit of this approach is to get a deeper insight into short term effects of single foods or beverages on inflammatory and prooxidative processes in humans by using short term intense physical activity as a stress model. One major practical aspect of this approach is to assess dietary components with respect to their pro- or anti-inflammatory-/oxidative stress potential regarding e.g. non-communicable diseases such as type 2 diabetes, coronary heart disease or the metabolic syndrome. Furthermore, it could help to reduce inflammation or oxidative stress during or following high intense physical exercise in order to reduce the stress response during training or competition in order to enhance regeneration and to foster the training gain in sports.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- acute consumption of anti- and pro- inflammatory foods (n=22) and beverages (n=20) 2 hour prior to intense physical activity in healthy female subjects (in total 42 subjects)
| Arm | Type | Receives |
|---|---|---|
| Impact of GT, coffee, OJ, PGJ, milk, SSB on exercise induced oxidative stress&inflammation | Experimental | Other: Nutritionsingle consumption of one cup of green tea (GT), coffee, orange juice (OJ), pomegranate juice (PGJ), milk and sugar sweetened beverage (SSB) 2 hours prior to a 30-min- HIIT resistance circuit exercise in healthy human subjects |
| Impact of choc, bcc, fl-oil, blueb., r&w bread on exercise induced oxidative stress&inflammation | Experimental | Other: Nutritionsingle consumption of one proportion of dark chocolate (choc), broccoli (bcc), flaxseed oil, blueberries, white bread and whole grain bread (r = refined \& w = whole grain) 2 hours prior to a 30-min-HIIT resistance circuit exercise in healthy human subjects |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- female human subjects
- aged 18-40 years
- no chronical diseases
- not more than 120 minutes of physical activity per week
- no regular resistance training within the past 6 months
Key exclusion criteria (6 listed)
- contraindications against physical activity
- anemia
- fructose or lactose intolerance
- smoking
- medications with influence on ROS levels or inflammation
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 |
|---|---|---|
| Nutritionacute single dose nutrition intervention | Other | Impact of GT, coffee, OJ, PGJ, milk, SSB on exercise induced oxidative stress&inflammation, Impact of choc, bcc, fl-oil, blueb., r&w bread on exercise induced oxidative stress&inflammation |
Primary outcome
ROS change
Time frame: change from baseline to 2.5 hours
ROS (change from baseline = after overnight fasting to post exercise (=after 2.5 hours)
IL-6 change
Time frame: change from baseline to 2.5 hours
IL-6 (change from baseline = after overnight fasting to post exercise (=after 2.5 hours)
8 secondary outcomes
estradiol
Time frame: baseline
DNA damage (comet assay
Time frame: change from baseline to 2.5 hours
MDA change
Time frame: change from baseline to 2.5 hours
hs-CRP change
Time frame: change from baseline to 2.5 hours
FRAP
Time frame: change from baseline to 2.5 hours
Polyphenol Content
Time frame: change from baseline to 2.5 hours
Lipidomics
Time frame: change from baseline to 2.5 hours
Protein Carbonyls
Time frame: change from baseline to 2.5 hours
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 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Markus Gassner, MSc principal investigator
University Assistant
Daniel König, Univ Prof study director
Professor of sports nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition in people with Inflammatory Response and Oxidative Stress, run by University of Vienna at 1 site in Austria.
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 7 inclusion and 6 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 Jul 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 Austria. 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?
ROS change (time frame: change from baseline to 2.5 hours). The study lists 2 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 Jul 2025.