Evaluation of the Effects of HH-205M Intake on Oxygen Metabolism through a Randomized, Double-Blind, Placebo-Controlled, Crossover Human Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 48
研究概览
简要总结
Four hours after a single administration of HH-205M, no clear differences from placebo were observed in total exercise duration, exercise duration after the respiratory exchange ratio exceeded 1.0 (RER>1.0), or SOD activity. In contrast, after one week of repeated supplementation, total exercise duration in the HH-205M condition increased by approximately 68 seconds (7.6%) from baseline, representing an improvement approximately 3.5% greater than that observed with placebo. Exercise duration after RER exceeded 1.0 increased by approximately 84 seconds (36.3%) in the HH-205M condition, compared with an increase of approximately 27 seconds in the placebo condition. Blood SOD activity, an indicator of antioxidant defense, also increased by approximately 23.8% from baseline. Overall, the findings suggest that one week of repeated HH-205M supplementation, rather than a single administration, may positively affect the ability of elite athletes to sustain maximal and high-intensity exercise and may strengthen antioxidant defense
研究设计
- 研究类型
- Interventional
- 主要目的
- Other(To compare the effects of a single dose and one week of repeated HH-205M intake with placebo on oxygen metabolism, exercise performance, and fatigue-related physiological indicators in elite athletes), Intervention Model : Cross-over, Blinding/Masking : Double, Blinding Target : Subject, Investigator, Allocation : RCT
入排标准
- 年龄范围
- 18(Year) 至 No Limit（—）
- 性别
- Male
入选标准
- •? Male elite athletes aged 18 years or older who have voluntarily provided written informed consent to participate in the study.
- •? Individuals who have had no major illnesses within the past 6 months and are considered medically eligible to participate in the study.
- •? Individuals who are able to comply with the study procedures, including the assessment schedule and investigational product administration protocol, throughout the study period.
- •?Individuals who are able to communicate in Korean sufficiently to understand the explanation of the study procedures and potential risks.
排除标准
- •?Human Clinical Trial–Related
- •?Individuals who have not provided written informed consent to participate in the study.
- •?Individuals who have participated in another human clinical trial within the past 2–3 months.
- •?Medical Conditions and Health Status
- •?Individuals who have undergone surgery within the past 6 months.
- •?Individuals with significant chronic diseases or infectious diseases, including cardiovascular disease, liver or kidney disease, cancer, or hypertension.
- •?Individuals with thyroid disorders, gastrointestinal diseases, autoimmune diseases, or malabsorption syndrome.
- •?Individuals who are currently injured or undergoing medical treatment.
- •?Medication and Supplement Use
- •?Individuals currently taking medications that may affect carbohydrate or lipid metabolism, body weight, hormonal function, or immune function.
- •?Individuals currently taking medications that may influence the study outcomes, including immunosuppressants, nonsteroidal anti-inflammatory drugs (NSAIDs), or diuretics.
- •?Individuals who are currently consuming or have regularly consumed probiotic products within the past 3 months.
- •?Individuals with a history of allergy or adverse reactions to the investigational product or its components.
- •?Carriers of hepatitis B or hepatitis C virus.
- •?Individuals who are deemed unsuitable for participation based on the medical judgment of the Principal Investigator.