- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05242978
Acute Impact of Different Foods and Beverages on Exercise Induced Oxidative Stress and Inflammation
November 28, 2023 updated by: Daniel König, University of Vienna
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.
Study Overview
Status
Enrolling by invitation
Intervention / Treatment
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, seventy-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 the three groups beverage consumption, plantbased foods and protein sources.
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 Type
Interventional
Enrollment (Estimated)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Markus Gassner, MSc
- Phone Number: +436502007014
- Email: markus.gassner@univie.ac.at
Study Contact Backup
- Name: Daniel König, Univ Prof
- Phone Number: +43-1-4277-59130
- Email: daniel.koenig@univie.ac.at
Study Locations
-
-
-
Vienna, Austria, 1070
- University of Vienna
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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%
- Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Impact of GT, coffee, OJ, PGJ, milk, SSB on exercise induced oxidative stress&inflammation
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
|
acute single dose nutrition intervention
|
Experimental: Impact of r&p meat, cheese, eggs, tofu, salmon, on exercise induced oxidative stress&inflammation
single consumption of one proportion of red meat (r meat), full fat cheese, eggs, tofu, salmon and processed meat (p meat) 2 hours prior to a 30-min- HIIT resistance circuit exercise in healthy human subjects
|
acute single dose nutrition intervention
|
Experimental: Impact of choc, bcc, fl-oil, blueb., r&w bread on exercise induced oxidative stress&inflammation
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
|
acute single dose nutrition intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
change from baseline to 2.5 hours
|
MDA change
Time Frame: change from baseline to 2.5 hours
|
MDA (change from baseline = after overnight fasting to post exercise (=after 2.5 hours)
|
change from baseline to 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)
|
change from baseline to 2.5 hours
|
hs-CRP change
Time Frame: change from baseline to 2.5 hours
|
hs-CRP (change from baseline = after overnight fasting to post exercise (=after 2.5 hours)
|
change from baseline to 2.5 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
estradiol
Time Frame: baseline
|
17-beta-estradiol
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Markus Gassner, MSc, University Assistant
- Study Director: Daniel König, Univ Prof, Professor of sports nutrition
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 17, 2022
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
January 26, 2022
First Submitted That Met QC Criteria
February 7, 2022
First Posted (Actual)
February 16, 2022
Study Record Updates
Last Update Posted (Actual)
December 5, 2023
Last Update Submitted That Met QC Criteria
November 28, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-00743
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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