NCT06878040

Brief Summary

The data of 16 trained men from the Polish Youth National Rowing. All athletes presented as medically fit, with no underlying health problems. In this cohort, baseline serum ferritin levels were considered, and the athletes were divided into two groups:

  1. 1.Serum ferritin \<75 ng/ml (SF\<75): n=9
  2. 2.Serum ferritin \>75 ng/ml (SF\>75): n=7

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

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
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 14, 2025

Completed
Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

March 10, 2025

Last Update Submit

March 17, 2025

Conditions

Outcome Measures

Primary Outcomes (12)

  • Ferritin

    Concentration of ferritin \[ng/mL\]. ELISA method by the test manufacturer's instructions

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Iron

    The iron level \[µg/dL\] will be determined using the colorimetric method on the SPECTROstar Nano reader.

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Interleukin-6 (Il-6)

    Concentration of IL-6 \[ng/L\]. ELISA method by the test manufacturer's instructions

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Hepcidin

    Concentration of hepcidin \[ng/mL\]. ELISA method by the test manufacturer's instructions

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Transferrin

    Concentration of transferrin \[mg/mL\]. ELISA method by the test manufacturer's instructions

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • The Blood morphology - RBC (Red Blood Cells)

    RBC (Red Blood Cells) \[106 × µL-1\] determined on the MYTHIC 18 hematology analyzer (Orphee Medical, Geneva, Switzerland).

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • The Blood morphology- HGB (Hemoglobin)

    HGB (Hemoglobin) \[g/dL\] determined on the MYTHIC 18 hematology analyzer (Orphee Medical, Geneva, Switzerland).

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • The Blood morphology- HCT (Hematocrit)

    HCT (Hematocrit) \[%\]determined on the MYTHIC 18 hematology analyzer (Orphee Medical, Geneva, Switzerland).

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • The Blood morphology- MCV (Mean Corpuscular Volume)

    MCV (Mean Corpuscular Volume)\[fl\] determined on the MYTHIC 18 hematology analyzer (Orphee Medical, Geneva, Switzerland).

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • The Blood morphology- MCH (Mean Corpuscular Hemoglobin)

    MCH (Mean Corpuscular Hemoglobin) \[pg\] determined on the MYTHIC 18 hematology analyzer (Orphee Medical, Geneva, Switzerland).

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • The Blood morphology- MCHC (Mean Corpuscular Hemoglobin Concentration)

    MCHC (Mean Corpuscular Hemoglobin Concentration) \[g x dL-1\] determined on the MYTHIC 18 hematology analyzer (Orphee Medical, Geneva, Switzerland).

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • The Blood morphology- RDW (Red Blood cells Distribution Width)

    RDW (Red Blood cells Distribution Width) \[%\] determined on the MYTHIC 18 hematology analyzer (Orphee Medical, Geneva, Switzerland).

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

Secondary Outcomes (7)

  • Antropometric characteristic - height

    Day 1 after overall fast

  • Antropometric characteristic - weight

    Day 1 after overall fast

  • Food record - energy

    Day before the Day 1, in the morning at Day 1

  • Food record - protein

    Day before the Day 1, in the morning at Day 1

  • Food record - carobhydrates

    Day before the Day 1, in the morning at Day 1

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years - 24 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Youth National Rowing Team of Poland

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)

Poznań University of Physical Education,

Poznan, 61-871, Poland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Eppendorf tubes with serum.

MeSH Terms

Conditions

InflammationAnemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsAnemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2025

First Posted

March 14, 2025

Study Start

April 1, 2023

Primary Completion

June 10, 2023

Study Completion

June 10, 2023

Last Updated

March 20, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations