A Randomized, Controlled Clinical Study on Creatine Monohydrate Supplement: Pharmacokinetics, Bioavailability, Safety and Efficacy in Enhancing Strength, Power, Muscle volumization,Energy, and Lean Body Mass in Active Males.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Phase I:
研究概览
简要总结
Despite the popularity and widespread use of creatine supplements, a comprehensive understanding of the mechanisms governing the absorption, distribution, metabolism, and excretion of creatine is crucial. This is especially important to optimize supplementation strategies, specifically tailored for active males. Bioavailability studies play a key role in demonstrating that recommended doses of creatine monohydrate effectively increase muscle creatine content, thereby contributing to its potential efficacy in enhancing physical performance. Ensuring the safety profile of prolonged creatine supplementation, especially in active males undergoing resistance training, is paramount. Therefore, a comprehensive investigation will provide evidence-based recommendations for both athletes and healthcare professionals. Our study seeks to rigorously evaluate the efficacy of creatine monohydrate in enhancing strength, power, muscle volumization, energy levels, and lean body mass in active males through controlled and randomized clinical trials. This approach substantiates the potential ergogenic benefits of creatine monohydrate supplementation while ensuring the absence of untoward side effects. Moreover, the investigational product is designed for convenient consumption, with greater solubility (being 100% water-soluble) and no residual content, facilitating faster absorption into the blood and potentially promoting more efficient transport of creatine to the muscles. Creatine monohydrate, considered the gold standard for comparing other purported sources of creatine, boasts well-established physiochemical properties, high bioavailability, and extensive evidence supporting its efficacy and safety. Our study aims to contribute to the existing body of evidence supporting the bioavailability, efficacy, and safety of creatine monohydrate, aligning with professional guidelines and regulatory approvals in major global markets. This enables consumers to make informed decisions about the supplements they choose to consume. Thus, the proposed study on creatine monohydrate supplementation in active males aims to provide comprehensive insights into its pharmacokinetics, bioavailability, safety profile, efficacy in enhancing physical performance, and comparison with other forms of creatine. By addressing these critical aspects, the study endeavours to contribute to evidence-based recommendations for the use of creatine monohydrate as a dietary supplement, particularly in the active males.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male participant of age 18-40 years having BMI less than 30 kg/m
- •Participants in normal health as determined by personal medical history, clinical examination including vital signs, and clinically acceptable results of laboratory examinations.
- •3.Engaged in regular resistance training for at least 1 year and agreeing to continue throughout the study.
- •No previous history of creatine supplementation in the last one month, However, participants from phase I are eligible to continue their participation in phase II after 7 days of washout period.
- •Availability of volunteers for the entire study duration.
- •Ability to fast for at least 14.00 hours and consume standard meals
- •Willingness to provide consent and agree to come for follow up associated with the study.
排除标准
- •Any known contraindications to creatine supplementation;
- •Any individual who is currently being treated or is diagnosed with a cardiac, respiratory, circulatory, musculoskeletal, metabolic obesity, immune, autoimmune, psychiatric, hematological, neurological, or endocrinological disorder or disease;
- •Current use of performance-enhancing drugs or supplements;
- •History of renal and/or liver dysfunction or disease;
- •Taking medications that affect muscle biology;
- •Planning to travel for more than 1 week during the study, where there will be NO access to a fitness facility;
- •Any condition that could, in the opinion of the investigator, preclude the participants ability to complete the study or that may confound study outcomes.
结局指标
主要结局
Phase I:
时间窗: 1) Pharmacokinetic blood samples will be | collected | at pre-dose [within 45 min before IP | administration] & post-dose at at 0.5 hour (h), 1h, 2 h, 3 h, 4 h, 5 h, and 6 h. | 2)Phase II | At day 1, weeks 4, and 8.
1. Pharmacokinetics parameters like F, Cmax,
时间窗: 1) Pharmacokinetic blood samples will be | collected | at pre-dose [within 45 min before IP | administration] & post-dose at at 0.5 hour (h), 1h, 2 h, 3 h, 4 h, 5 h, and 6 h. | 2)Phase II | At day 1, weeks 4, and 8.
Tmax, AUC0-t, AUC0-infinity, t1/2, and Kel will
时间窗: 1) Pharmacokinetic blood samples will be | collected | at pre-dose [within 45 min before IP | administration] & post-dose at at 0.5 hour (h), 1h, 2 h, 3 h, 4 h, 5 h, and 6 h. | 2)Phase II | At day 1, weeks 4, and 8.
be calculated from the concentration Vs. time
时间窗: 1) Pharmacokinetic blood samples will be | collected | at pre-dose [within 45 min before IP | administration] & post-dose at at 0.5 hour (h), 1h, 2 h, 3 h, 4 h, 5 h, and 6 h. | 2)Phase II | At day 1, weeks 4, and 8.
data.
时间窗: 1) Pharmacokinetic blood samples will be | collected | at pre-dose [within 45 min before IP | administration] & post-dose at at 0.5 hour (h), 1h, 2 h, 3 h, 4 h, 5 h, and 6 h. | 2)Phase II | At day 1, weeks 4, and 8.
Phase II:
时间窗: 1) Pharmacokinetic blood samples will be | collected | at pre-dose [within 45 min before IP | administration] & post-dose at at 0.5 hour (h), 1h, 2 h, 3 h, 4 h, 5 h, and 6 h. | 2)Phase II | At day 1, weeks 4, and 8.
1. Changes in muscle strength using a standard
时间窗: 1) Pharmacokinetic blood samples will be | collected | at pre-dose [within 45 min before IP | administration] & post-dose at at 0.5 hour (h), 1h, 2 h, 3 h, 4 h, 5 h, and 6 h. | 2)Phase II | At day 1, weeks 4, and 8.
plate-loaded leg press and chest press machine,
时间窗: 1) Pharmacokinetic blood samples will be | collected | at pre-dose [within 45 min before IP | administration] & post-dose at at 0.5 hour (h), 1h, 2 h, 3 h, 4 h, 5 h, and 6 h. | 2)Phase II | At day 1, weeks 4, and 8.
Rep max for leg press and chest press at day 1,
时间窗: 1) Pharmacokinetic blood samples will be | collected | at pre-dose [within 45 min before IP | administration] & post-dose at at 0.5 hour (h), 1h, 2 h, 3 h, 4 h, 5 h, and 6 h. | 2)Phase II | At day 1, weeks 4, and 8.
weeks 4, and 8.
时间窗: 1) Pharmacokinetic blood samples will be | collected | at pre-dose [within 45 min before IP | administration] & post-dose at at 0.5 hour (h), 1h, 2 h, 3 h, 4 h, 5 h, and 6 h. | 2)Phase II | At day 1, weeks 4, and 8.
2. Changes in hypertrophy measurements of
时间窗: 1) Pharmacokinetic blood samples will be | collected | at pre-dose [within 45 min before IP | administration] & post-dose at at 0.5 hour (h), 1h, 2 h, 3 h, 4 h, 5 h, and 6 h. | 2)Phase II | At day 1, weeks 4, and 8.
each muscle site (cm) of the biceps, triceps,
时间窗: 1) Pharmacokinetic blood samples will be | collected | at pre-dose [within 45 min before IP | administration] & post-dose at at 0.5 hour (h), 1h, 2 h, 3 h, 4 h, 5 h, and 6 h. | 2)Phase II | At day 1, weeks 4, and 8.
quads, and hamstrings at day 1, weeks 4, and 8.
时间窗: 1) Pharmacokinetic blood samples will be | collected | at pre-dose [within 45 min before IP | administration] & post-dose at at 0.5 hour (h), 1h, 2 h, 3 h, 4 h, 5 h, and 6 h. | 2)Phase II | At day 1, weeks 4, and 8.
次要结局
- Phase II:(1. Changes in muscle endurance using a)
研究者
Dr Ramshyam Agarwal
Lokmanya Medical Research Centre