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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05242978
Other study ID # 2021-00743
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date May 17, 2022
Est. completion date December 31, 2024

Study information

Verified date November 2023
Source University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 24
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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 Design


Intervention

Other:
Nutrition
acute single dose nutrition intervention

Locations

Country Name City State
Austria University of Vienna Vienna

Sponsors (1)

Lead Sponsor Collaborator
University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary ROS change ROS (change from baseline = after overnight fasting to post exercise (=after 2.5 hours) change from baseline to 2.5 hours
Primary MDA change MDA (change from baseline = after overnight fasting to post exercise (=after 2.5 hours) change from baseline to 2.5 hours
Primary IL-6 change IL-6 (change from baseline = after overnight fasting to post exercise (=after 2.5 hours) change from baseline to 2.5 hours
Primary hs-CRP change hs-CRP (change from baseline = after overnight fasting to post exercise (=after 2.5 hours) change from baseline to 2.5 hours
Secondary estradiol 17-beta-estradiol baseline
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