Effect of Supplementation With Anthocyanins on Iron Metabolism in Female Swimmers

NCT06486623 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-07-03

No results posted yet for this study

Summary

The study included 8-weeks supplementation of black chokeberry extract with 18% standardization of the anthocyanins content (dose 2×200 mg per day), or a placebo product that was made from chokeberry fiber.

Purpose:

The aim of the study is effectiveness check of black chokeberry intake as a potential factor which, due to its ability to reduce inflammation and chelate iron ions, will have an impact on minimizing undesirable changes in the red blood cell system.

Hypothesis:

Main hypothesis: Supplementation of black chokeberry (Aronia melanocarpa) has a positive effect on iron economy of female swimmers.

Auxiliary hypotheses:

1. Supplementation of black chokeberry enhances the antioxidant status and has a positive effect on the prooxidant-antioxidant balance.
2. Supplementation of black chokeberry reduce inflammation induced by intensive exercises, by reducing inflammatory markers.

Study plan:

Before first term of the study:

Control of Menstrual Cycle Phases since March 2023 (installing the application on the phone - Menstrual Period Tracker calendar).

First term of the study:

1. Menstrual cycle control survey.
2. Conduct a body composition analysis.
3. Collection of blood samples before the exercise test for biochemical determinations.
4. Exercise test in the swimming pool - crawl style intensive test (800 m + 200 m + 50 m).
5. Collection of blood immediately after exercise and 3 hours later.
6. Supplementation for nearly 56 days, depending on the length of the menstrual cycle.

Second term of the study:

Repeat the measurements from the 1st date of test.

Participants: The group of selective and homogeneous female swimmers, who train swimming intensively and attend the Sports Championship School Complex.

Conditions

  • Iron Deficiencies
  • Inflammation
  • Oxidative Stress
  • Female Athlete Triad

Interventions

DRUG

Black chokeberry extract in capsules with 18% standardization of the anthocyanins content

Supplement group: supplement of diet - black chokeberry extract (capsules) with 18% standardization of the anthocyanins content (one capsule contained 200 mg). Each capsule also contained: chokeberry fiber, E460b magnesium salts of stearic acid (anti-caking agent), E551 silicon dioxide (anti-caking agent), hydrocypropyl methylcellulose (capsule shell) and E171 titanium dioxide (shell colour). The producer of all capsules is MLD Biotrade in Poznan.

DRUG

Chokeberry fiber in capsules

Placebo group: placebo product - chokeberry fiber (placebo capsules, which were made from chokeberry fiber). The producer of all capsules is MLD Biotrade in Poznan.

Sponsors & Collaborators

  • Poznan University of Physical Education

    lead OTHER

Principal Investigators

  • Marta Mydłowska, PhD student · Poznań University of Physical Education, Faculty of sport sciences in Gorzów Wielkopolski

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2023-12-28
Completion
2023-12-28

Countries

  • Poland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06486623 on ClinicalTrials.gov