NCT05242978

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 16, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

May 17, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

July 4, 2025

Status Verified

November 1, 2024

Enrollment Period

2 years

First QC Date

January 26, 2022

Last Update Submit

July 1, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • ROS change

    ROS (change from baseline = after overnight fasting to post exercise (=after 2.5 hours)

    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)

    change from baseline to 2.5 hours

Secondary Outcomes (8)

  • estradiol

    baseline

  • DNA damage (comet assay

    change from baseline to 2.5 hours

  • MDA change

    change from baseline to 2.5 hours

  • hs-CRP change

    change from baseline to 2.5 hours

  • FRAP

    change from baseline to 2.5 hours

  • +3 more secondary outcomes

Study Arms (2)

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

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

Other: Nutrition

Interventions

acute single dose nutrition intervention

Impact of GT, coffee, OJ, PGJ, milk, SSB on exercise induced oxidative stress&inflammationImpact of choc, bcc, fl-oil, blueb., r&w bread on exercise induced oxidative stress&inflammation

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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%

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vienna

Vienna, Austria, 1070, Austria

Location

MeSH Terms

Interventions

Nutritional Status

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Officials

  • Markus Gassner, MSc

    University Assistant

    PRINCIPAL INVESTIGATOR
  • Daniel König, Univ Prof

    Professor of sports nutrition

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 26, 2022

First Posted

February 16, 2022

Study Start

May 17, 2022

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

July 4, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations