A clinical study to evaluate the impact of red and green spinach extract on performance, strength, stamina, and reducing muscle breakdown as well as promoting muscle synthesis in physically active individuals.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- 1.Evaluate the impact of red and green spinach extract on physical performance, subjective measures like exertion and muscle fatigue, and physical measures, cardiorespiratory health and endurance, anthropometric measurements, hypertrophy, and body composition over a 8-week in physically active individuals.
研究概览
简要总结
The present study is designed to evaluate the effectiveness of a combination of red and green spinach extract in improving performance, strength, and stamina, and reducing muscle breakdown in physically active individuals. The rationale for conducting this study is multifaceted:
Intervention and Nutritional Approach: Spinach is known for its rich nutrient profile, including vitamins, minerals, and phytochemicals, which are believed to confer various health benefits. By harnessing the potential synergistic effects of red and green spinach extract, this study adopts a nutritional approach to enhancing physical performance and muscle health, offering a promising avenue for individuals looking to support their fitness goals.
Moreover, there is limited scientific literature on the specific effects of red and green spinach extract on physical performance and muscle health. As such, this study seeks to contribute to the body of knowledge by providing valuable insights into the potential benefits of this intervention.
To our knowledge, this study represents the first investigation on a global scale into the combined effects of red and green spinach extract on physical performance and muscle health. By exploring the potential short and long-term benefits of this intervention, the study aims to provide valuable insights that may have implications for individuals worldwide seeking to optimize their exercise performance and muscle mass.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and female participants aged between 18-40 years having BMI less than 35 kg/m2 2.Resting blood pressure averaging less than 140/90 mmHg 3.Not on any medication for cardiovascular and metabolic disorders 4.Engaged in regular resistance training (comprising of cardio and strength training) for at least 1 year and willing to continue the same during the study 5.Participants consuming whey protein and possess a sufficient level of knowledge regarding the importance of dietary and lifestyle factors relevant to the study, as determined by the investigator 6.Willing to provide consent and come for regular follow-up visits.
排除标准
- •1.Participants with any acute illness requiring immediate medical care; 2.Participants with any chronic medical condition; 3.Participants with sedentary lifestyles are not able or not advised to undergo the resistance training as per protocol; 4.Any clinically relevant macro or micro-nutrient deficiency as per investigator discretion; 5.Any other condition which proves the participant unfit for the study participation; 6.Any known cardiovascular or metabolic disease; 7.Pregnant women, lactating women, women of child bearing potential not following adequate contraceptive measures, women who were found positive for urine pregnancy test; 8.Participants who are taking any herbal nutraceutical supplements except plant-based protein supplementation.
结局指标
主要结局
1.Evaluate the impact of red and green spinach extract on physical performance, subjective measures like exertion and muscle fatigue, and physical measures, cardiorespiratory health and endurance, anthropometric measurements, hypertrophy, and body composition over a 8-week in physically active individuals.
时间窗: Baseline, week 4 and week 8
2.Assess the efficacy of red and green spinach extract on changes in muscle strength, biochemical markers, recovery from exercise and laboratory investigations in physically active individuals.
时间窗: Baseline, week 4 and week 8
次要结局
- 1.Adverse events profile.(2.Compliance and tolerability of the investigational product.)
研究者
Dr Mahesh Kharade
Sangvi Multispeciality Hospital Pvt. Ltd