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临床试验/NCT06486623
NCT06486623已完成1 期

Effect of Supplementation With Anthocyanins Contained in Black Chokeberry (Aronia Melanocarpa) on Selected Indicators of Iron Metabolism in Female Swimmers

Poznan University of Physical Education1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2023年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
22
试验地点
1
主要终点
Physiological parameters of iron metabolism indicator V

研究概览

简要总结

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.

详细描述

This 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. The first date of research completed the group of twenty-four and homogeneous female swimmers, who train swimming intensively and attend the Sports Championship School Complex. The second date of research completed the group of twenty-two selective and homogeneous female swimmers, who train swimming intensively and attend the Sports Championship School Complex.

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
12 Years 至 19 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

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.

干预措施: Black chokeberry extract in capsules with 18% standardization of the anthocyanins content (Drug)

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.

干预措施: Chokeberry fiber in capsules (Drug)

结局指标

主要结局

Physiological parameters of iron metabolism indicator V

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

ferritin \[ng/ml\]

Physiological parameters of blood morphology III

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

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

Physiological parameters of iron metabolism indicator III

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

transferrin \[mg/ml\]

Physiological parameters of blood morphology I

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

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

Physiological parameters of iron metabolism indicator I

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

iron \[µg/dl\]

Physiological parameters of iron metabolism indicator VI

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

erythroferrone \[ng/mL\]

Physiological parameters of iron metabolism indicator II

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

hepcidin \[ng/ml\]

Physiological parameter of hormonal indicator III

时间窗: At each exercise test (up to 15 minute before exercise)

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

Physiological parameters of iron metabolism indicator IV

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

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

Physiological parameters of immunological indicator II

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

interleukin 2 \[ng/L\]

Physiological parameters of immunological indicator IV

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

C-reactive protein \[mg/dL\]

Physiological parameter of hormonal indicator II

时间窗: At each exercise test (up to 15 minute before exercise)

estradiol \[pg/ml\]

Physiological parameters of blood morphology II

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

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

Physiological parameters of antioxidant-prooxidant indicator

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

total antioxidant capacity \[mmol/l\]

Physiological parameter of hormonal indicator I

时间窗: At each exercise test (up to 15 minute before exercise)

progesterone \[ng/ml\]

Other physiological parameter I

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

myoglobin \[ng/ml\]

Physiological parameters of immunological indicator I

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

interleukin 6 \[ng/L\]

Physiological parameter of hormonal indicator IV

时间窗: At each exercise test (up to 15 minute before exercise)

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

Other physiological parameter (with capillary blood - earlobe)

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

lactic acid \[mmol/l\]

Physiological parameters of immunological indicator III

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

interleukin 10 \[ng/L\]

Other physiological parameter II

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

hypoxanthine \[mmol/l\]

次要结局

  • 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))

研究者

发起方
Poznan University of Physical Education
申办方类型
Other
责任方
Sponsor

研究点 (1)

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