NCT06133751

Brief Summary

Purpose: To analyze the effects of 8-week supplementation with anthocyanin compounds contained in black chokeberry (Aronia melanocarpa) on indicators of inflammation and oxidative stress. Hypothesis: Supplementation with anti-inflammatory and antioxidant anthocyanin compounds improves recovery from intense exercise by reducing inflammation and oxidative stress in highly trained rowers The study consisted of a nutritional intervention (supplementation) - with compounds of natural origin - chokeberry extract (capsules) - 18% standardized for anthocyanin content (dose 3 x 200 mg per day) - that is, 107 mg of pure anthocyanins per day, or a placebo product that was made from chokeberry fiber Study plan I term of the study

  1. 1.Conduct a body composition analysis, body height, food diary, self reported gastrointestinal scale
  2. 2.Collection of blood samples before the exercise test for biochemical determinations.
  3. 3.Exercise test of 2000m on a rowing ergometer.
  4. 4.Collection of blood immediately after exercise and 1 hours after
  5. 5.Collection of blood for biochemical determinations 24 hours after the end of the exercise test
  6. 6.Supplementation for 8 weeks 2nd test date Repeat the measurements from the 1st test date.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2023

Shorter than P25 for phase_4

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

Study Start

First participant enrolled

April 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 15, 2023

Completed
Last Updated

April 26, 2024

Status Verified

October 1, 2023

Enrollment Period

2 months

First QC Date

October 27, 2023

Last Update Submit

April 23, 2024

Conditions

Outcome Measures

Primary Outcomes (11)

  • Level of total antioxidants (TAC)

    ELISA kits (SunRed Biotechnology Company) - Indicators of pro-oxidant-antioxidant balance

    8 weeks

  • interleukins: IL-2, IL-6, IL-10

    ELISA kits (SunRed Biotechnology Company) - Immunological indicators

    8 weeks

  • lactic acid

    Diaglobal, Berlin, Germany)

    8 weeks

  • LBP (lipopolysacharide-binding pro)

    ELISA kits (SunRed Biotechnology Company) - Gut parameter

    8 weeks

  • level of lipid peroxidation products (TBARS)

    ELISA kits (SunRed Biotechnology Company) - Indicators of pro-oxidant-antioxidant balance

    8 weeks

  • (NO) nitric oxide

    obtained by indirect method Griessa - Indicators of pro-oxidant-antioxidant balance

    8 weeks

  • comet assay (DNA damage)

    comet assay BioTechne

    8 weeks

  • tumor necrosis factor (TNF α)

    ELISA kits (SunRed Biotechnology Company) - Immunological indicators

    8 weeks

  • myoglobin

    ELISA kits (SunRed Biotechnology Company)

    8 weeks

  • I-FABP (intestinal fatty acid binding protein)

    ELISA kits (SunRed Biotechnology Company) - Gut parameter

    8 weeks

  • Claudin3

    ELISA kits (SunRed Biotechnology Company) - Gut parameter

    8 weeks

Secondary Outcomes (11)

  • gastrointestinal symptom scale

    8 weeks

  • energy [kcal]

    8 weeks

  • protein [g]

    8 weeks

  • fat [g]

    8 weeks

  • carbohydrate [g]

    8 weeks

  • +6 more secondary outcomes

Study Arms (2)

Supplemented group

EXPERIMENTAL

Athletes in the supplemented group (n=7) consumed capsules with highly concentrated 18% chokeberry extract. One capsule contained 200 mg. In addition to chokeberry extract, each capsule also contained chokeberry fiber, E460b magnesium salts of stearic acid (anti-caking agent), E551 silicon dioxide (anti-caking agent), hydroxypropyl methylcellulose (capsule shell) and E171 titanium dioxide (shell color). The rowers (both supplemented and control group) took 3 capsules a day (at breakfast, lunch and dinner) for 8 weeks. The athletes sipped each capsule with a glass of water.

Drug: black chokeberry (Aronia melanocarpa)

Placebo group

PLACEBO COMPARATOR

The control group (n=8) consumed capsules that were made from chokeberry fiber. The rowers (both supplemented and control group) took 3 capsules a day (at breakfast, lunch and dinner) for 8 weeks. The athletes sipped each capsule with a glass of water.

Drug: Placebo

Interventions

Black chokeberry capsules standardized for anthocyanin compounds

Supplemented group

Chokeberry fiber placebo capsules

Placebo group

Eligibility Criteria

Age18 Years - 24 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Training experience a minimum of five years
  • Minimum training time per week 240 minute
  • Membership in the Youth National Rowing Team of Poland
  • Completion of the 2000m ergometer test on two test dates

You may not qualify if:

  • Taking other supplements containing anthocyanin compounds during the study period or a month earlier
  • Antibiotic therapy
  • Health problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Physical Education in Poznan

Poznan, Poland

Location

Related Publications (1)

  • Kaczmarczyk S, Kasperska A, Dziewiecka H, Ostapiuk-Karolczuk J, Cichon-Wozniak J, Basta P, Skarpanska-Stejnborn A. A single 2000-meter exercise test to assess exercise adaptation in elite rowers during the preparatory phase. Front Physiol. 2025 Aug 12;16:1544637. doi: 10.3389/fphys.2025.1544637. eCollection 2025.

MeSH Terms

Conditions

Myositis, Inclusion Body

Condition Hierarchy (Ancestors)

MyositisMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Anna Skarpańska-Stejnborn, Professor

    Poznan University of Physical Education

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Youth National Rowing Team of Poland
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Participants randomly divided into one of two groups. The supplemented group (n=7) receives chokeberry capsules, while the control group (n=8) receives a placebo product.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2023

First Posted

November 15, 2023

Study Start

April 1, 2023

Primary Completion

June 10, 2023

Study Completion

June 10, 2023

Last Updated

April 26, 2024

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations