Effect of Supplementation With Anthocyanins on Iron Metabolism in Female Swimmers

NCT06486623 | Completed Phase 1 DMC

• 1 other identifier: MMydłowska_PhD
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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. 1.Supplementation of black chokeberry enhances the antioxidant status and has a positive effect on the prooxidant-antioxidant balance.
2. 2.Supplementation of black chokeberry reduce inflammation induced by intensive exercises, by reducing inflammatory markers.
3. 3.Menstrual cycle control survey.
4. 4.Conduct a body composition analysis.
5. 5.Collection of blood samples before the exercise test for biochemical determinations.
6. 6.Exercise test in the swimming pool - crawl style intensive test (800 m + 200 m + 50 m).
7. 7.Collection of blood immediately after exercise and 3 hours later.
8. 8.Supplementation for nearly 56 days, depending on the length of the menstrual cycle.

Conditions

Iron Deficiencies; Inflammation; Oxidative Stress; Female Athlete Triad

Outcome Measures

Primary Outcomes (21)

• Physiological parameters of blood morphology I

  erythrocytes: RBC \[10\^6/mL\], HGB \[g/dL\], HCT \[%\], MCV \[mm\^3\], MCH \[pg\], MCHC \[g/dL\], RDW \[%\],

  At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)

• Physiological parameters of blood morphology II

  leukocytes: WBC \[10\^3/mL\], LYM \[10\^3/mL\], MON \[10\^3/mL\], GRA \[10\^3/mL\], LYM \[%\], MON \[%\], GRA \[%\],

  At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)

• Physiological parameters of blood morphology III

  thrombocytes: PLT \[10\^3/mL\], MPV \[mm\^3\], PCT \[%\], PDW \[%\]

  At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)

• Physiological parameters of iron metabolism indicator I

  iron \[µg/dl\]

  At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)

• Physiological parameters of iron metabolism indicator II

  hepcidin \[ng/ml\]

  At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)

• Physiological parameters of iron metabolism indicator III

  transferrin \[mg/ml\]

  At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)

• Physiological parameters of iron metabolism indicator IV

  total iron-binding capacity (TIBC) \[µg/dl\]

  At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)

• Physiological parameters of iron metabolism indicator V

  ferritin \[ng/ml\]

  At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)

• Physiological parameters of iron metabolism indicator VI

  erythroferrone \[ng/mL\]

  At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)

• Physiological parameters of antioxidant-prooxidant indicator

  total antioxidant capacity \[mmol/l\]

  At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)

• Physiological parameters of immunological indicator I

  interleukin 6 \[ng/L\]

  At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)

• Physiological parameters of immunological indicator II

  interleukin 2 \[ng/L\]

  At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)

• Physiological parameters of immunological indicator III

  interleukin 10 \[ng/L\]

  At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)

• Physiological parameters of immunological indicator IV

  C-reactive protein \[mg/dL\]

  At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)

• Physiological parameter of hormonal indicator I

  progesterone \[ng/ml\]

  At each exercise test (up to 15 minute before exercise)

• Physiological parameter of hormonal indicator II

  estradiol \[pg/ml\]

  At each exercise test (up to 15 minute before exercise)

• Physiological parameter of hormonal indicator III

  luteinizing hormone (LH) \[mIU/ml\]

  At each exercise test (up to 15 minute before exercise)

• Physiological parameter of hormonal indicator IV

  follicle-stimulating hormone (FSH) \[mIU/ml\]

  At each exercise test (up to 15 minute before exercise)

• Other physiological parameter I

  myoglobin \[ng/ml\]

  At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)

• Other physiological parameter II

  hypoxanthine \[mmol/l\]

  At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)

• Other physiological parameter (with capillary blood - earlobe)

  lactic acid \[mmol/l\]

  At each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)

Secondary Outcomes (1)

• Physiological parameters of iron metabolism indicator VII

  Calculated with blood samples at each exercise test (up to 15 minute before exercise, up to 1 minute post exercise, 3 hours after)

Study Arms (2)

1. Supplemented group

EXPERIMENTAL

The supplemented group (n=12) consumed capsules with highly concentrated 18% chokeberry extract (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. The swimmers took 2 capsules a day (before breakfast and dinner) for nearly 56 days (depending on length menstrual cycle phase). The swimmers sipped each capsule with glass of water.

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

2. Placebo group

PLACEBO COMPARATOR

The control group (n=10) consumed capsules that were made from chokeberry fiber. The producer of all capsules is MLD Biotrade in Poznan. The swimmers took 2 capsules a day (before breakfast and dinner) for nearly 56 days (depending on length menstrual cycle phase). The swimmers sipped each capsule with glass of water.

Drug: Chokeberry fiber in capsules

Interventions

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

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.

Also known as: Aronia melanocarpa

1. Supplemented group

Chokeberry fiber in capsules DRUG

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

Also known as: Placebo product

2. Placebo group

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Current medical examinations issued by a sports medicine doctor
• Training experience a minimum of three years
• Student of a sports championship school team
• Consent of the athlete/legal guardian to participate in the research
• Completion of the exercise test in the swimming pool - crawl style intensive test (800 m + 200 m + 50 m) on two test deadline

You may not qualify if:

• Taking: oral contraceptive pills, supplements containing anthocyanin compounds during the study or a one month earlier
• Health problems
• Antibiotic therapy

Sponsors & Collaborators

• Poznan University of Physical Education: lead

Study Sites (1)

University of Physical Education in Poznan

Poznan, Poland

Location

MeSH Terms

Conditions

Iron Deficiencies; Inflammation; Female Athlete Triad Syndrome

Interventions

Capsules

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Relative Energy Deficiency in Sport; Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Marta Mydłowska, PhD student

  Poznań University of Physical Education, Faculty of sport sciences in Gorzów Wielkopolski

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: July 3, 2024
• Study Start: March 1, 2023
• Primary Completion: December 28, 2023
• Study Completion: December 28, 2023
• Last Updated: July 3, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)