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临床试验/NCT07777510
NCT07777510已完成不适用

Effects of Black Elderberry Supplementation on Blood Lactate Responses and Oxidative Stress Biomarkers in Young Men: A Randomized, Placebo-Controlled Trial

Kocatepe University1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2024年5月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
19
试验地点
1
主要终点
Catalase (CAT) Activity

研究概览

简要总结

his randomized, placebo-controlled trial investigated whether black elderberry (Sambucus nigra L.) supplementation affects blood lactate responses, oxidative stress biomarkers, and exercise-related physiological responses in young men who regularly exercise. Participants completed four assessment sessions: a pre-test and three supplementation phases involving a single dose, alternate-day supplementation for 14 days, and daily supplementation for 14 days. The anthocyanin group received black elderberry supplementation, while the control group received an identical placebo. Blood lactate, oxidative stress biomarkers, body composition, and exercise performance were assessed under standardized laboratory conditions across the study phases.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 27 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Male participants aged 18-27 years.
  • Engaged in regular exercise at least three times per week during the previous three months.
  • No history of cardiovascular, metabolic, or endocrine disease.
  • No use of dietary supplements during the preceding month.
  • Provided written informed consent before participation.

排除标准

  • Known allergy or intolerance to black elderberry or other berry-based supplements.
  • Serious musculoskeletal injury or surgery within the previous six months.
  • Failure to comply with the study protocol.
  • Development of any health problem that prevented continuation of the exercise protocol.

研究组 & 干预措施

Anthocyanin Group

Experimental

Participants received black elderberry (Sambucus nigra L.) supplementation according to the study protocol, including single-dose, alternate-day, and daily supplementation phases.

干预措施: Anthocyanin Group (Dietary Supplement)

Placebo Group

Placebo Comparator

Participants received placebo capsules identical in appearance and administration schedule to the black elderberry capsules.

干预措施: Placebo Group (Dietary Supplement)

结局指标

主要结局

Catalase (CAT) Activity

时间窗: Pre-test (before the exercise protocol) and 15 minutes after the exercise protocol at the end of each supplementation phase (single-dose, 14-day alternate-day, and 14-day daily supplementation).

Plasma catalase (CAT) activity was assessed at the pre-test and at the end of each supplementation phase. At the pre-test, venous blood was collected before the exercise protocol. During each supplementation phase, venous blood was collected 15 minutes after completion of the exercise protocol. In each supplementation phase, the final dose was administered approximately 2 hours before the exercise test. CAT activity was measured using a commercial ELISA kit (BT-LAB, Bioassay Technology Laboratory, Zhejiang, China) and reported in nmol/min/mL.

Glutathione (GSH) Level

时间窗: Pre-test (before the exercise protocol) and 15 minutes after the exercise protocol at the end of each supplementation phase (single-dose, 14-day alternate-day, and 14-day daily supplementation).

Plasma glutathione (GSH) level was assessed at the pre-test and at the end of each supplementation phase. At the pre-test, venous blood was collected before the exercise protocol. During each supplementation phase, venous blood was collected 15 minutes after completion of the exercise protocol. In each supplementation phase, the final dose was administered approximately 2 hours before the exercise test. GSH level was measured using a commercial ELISA kit (BT-LAB, Bioassay Technology Laboratory, Zhejiang, China) and reported in µmol/g

Malondialdehyde (MDA)

时间窗: Pre-test (before the exercise protocol) and 15 minutes after the exercise protocol at the end of each supplementation phase (single-dose, 14-day alternate-day, and 14-day daily supplementation).

Plasma malondialdehyde (MDA) concentration was assessed at the pre-test and at the end of each supplementation phase. At the pre-test, venous blood was collected before the exercise protocol. During each supplementation phase, venous blood was collected 15 minutes after completion of the exercise protocol. In each supplementation phase, the final dose was administered approximately 2 hours before the exercise test. MDA concentration was measured using a commercial ELISA kit (BT-LAB, Bioassay Technology Laboratory, Zhejiang, China) and reported in nmol/mL.

Superoxide Dismutase (SOD) Activity

时间窗: Pre-test (before the exercise protocol) and 15 minutes after the exercise protocol at the end of each supplementation phase (single-dose, 14-day alternate-day, and 14-day daily supplementation).

Plasma superoxide dismutase (SOD) activity was assessed at the pre-test and at the end of each supplementation phase. At the pre-test, venous blood was collected before the exercise protocol. During each supplementation phase, venous blood was collected 15 minutes after completion of the exercise protocol. In each supplementation phase, the final dose was administered approximately 2 hours before the exercise test. SOD activity was measured using a commercial ELISA kit (BT-LAB, Bioassay Technology Laboratory, Zhejiang, China) and reported in U/mL.

Nitric Oxide (NO)

时间窗: Pre-test (before the exercise protocol) and 15 minutes after the exercise protocol at the end of each supplementation phase (single-dose, 14-day alternate-day, and 14-day daily supplementation).

Plasma nitric oxide (NO) concentration was assessed at the pre-test and at the end of each supplementation phase. At the pre-test, venous blood was collected before the exercise protocol. During each supplementation phase, venous blood was collected 15 minutes after completion of the exercise protocol. In each supplementation phase, the final dose was administered approximately 2 hours before the exercise test. NO concentration was measured using a commercial ELISA kit (BT-LAB, Bioassay Technology Laboratory, Zhejiang, China) and reported in µmol/L.

Blood Lactate Concentration

时间窗: Baseline (pre-test), during the 3rd minute of exercise, immediately post-exercise, and 30 minutes post-exercise during recovery; measurements repeated after Baseline (pre-test), single-dose, alternate-day, and daily supplementation phases.

Blood lactate concentration measured from capillary blood samples using a portable lactate analyzer (EDGE).

次要结局

未报告次要终点

研究者

发起方
Kocatepe University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hilal Ertürk Yaşar

Assistant Professor

Kocatepe University

研究点 (1)

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