A double-blind, randomized, single dose, three-treatment, three-way crossover oral bioavailability study of beta alanine complex Plus in comparison with beta alanine complex and conventional beta alanine in healthy human adults under fasting conditions.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- 1. To evaluate the oral bioavailability of investigational product (beta-alanine complex Plus liquid (400 mg)), reference product I Beta-alanine complex liquid (400 mg)) and reference product II (Conventional beta-alanine liquid (400 mg)) in healthy, adult, Human participants under fasting conditions.
研究概览
简要总结
The benefits of beta-alanine supplementation on functional performance in older adults have been reported in several investigations. These human studies have demonstrated that supplementing with beta-alanine can delay fatigue, increase strength, and improve functional performance (e.g., sit to stand) . Limited research has indicated that beta-alanine supplementation in older adults is also associated with improved executive function. Although increasing tissue carnosine levels have been reported to improve health in older adults, there is only limited scientific evidence supporting the efficacy of beta-alanine as a therapeutic intervention to improve cognitive function and memory in this population. The increase in carnosine in the muscle has been considered as enhancing blood buffering capacity and decreasing neuromuscular fatigue. Thus, the rationale of supplementing with BA as an ergogenic aid has often been described to increase athletic performance.
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
- 50.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy, adult, male and female human subjects of age between 50-65 years with a body mass index (BMI) range between 18.50 kg per m2 to 24.99 kg per m2 .
- •Subject agrees avoid beta-alanine containing medications and dietary supplements from screening until last visit.
- •Subject agrees to avoid high activity physical exercise 72.00 hours prior to last visit
- •Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 29 days of check in.
- •Subjects whose screening laboratory values are within normal limits or considered by the physician or principal investigator to be of no clinical significance.
- •Healthy as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, musculoskeletal and central nervous systems) and vital sign assessments.
- •Generally healthy as documented by clinical laboratory assessments.
- •Non- smokers or ex-smokers.
- •Ex-smokers are defined as someone who has completely stopped smoking for at least the past 03 months.
- •Willing to consume ova-lacto vegetarian diet.
- •Willing to comply to all requirements of this study protocol as well as instructed by the study personnel
- •Female subjects within normal limits or clinically non-significant laboratory evaluation results for FSH and LH.
- •Generally healthy as documented by gynecological examination and breast examination (for female subjects during check-in only).
排除标准
- •Evidence or history of clinically significant medical conditions.
- •Evidence of allergy or known hypersensitivity to beta alanine or other related drugs or other related drugs.
- •Subjects with hepatic encephalopathy, cholestasis, myasthenia, pre-existing liver disease, alcohol abuse, existing tinnitus, renal or liver impairment and pre-existing gallbladder disease.
- •Any major illness in the last three months or any significant ongoing chronic medical illness.
- •Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, Musculoskeletal, respiratory, central nervous system, diabetes, psychosis or any other body system.
- •History of alcohol addiction or abuse.
- •Malabsorption syndrome that affects Beta alanine metabolism.
- •Heart failure, angina pectoris, ventricular arrhythmias or atrial fibrillation with more than100 per min ventricular rate.
- •Gastrointestinal bleeding in past three months.
- •Uncontrolled diabetes mellitus.
- •Active psychiatric disorder, intention for suicidal, disorders with Unconsciousness.
- •Psychopathic disorder, lack of cooperation.
- •Chronic obstructive lung disease or active smoking (more than 2 cigarettes in the past 6 months)
- •Taking more than 100 mg beta-alanine daily within 2 weeks to screening.
- •Consumption of caffeine and /or Xanthine containing products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.), tobacco containing products for at least 24.00 hours prior to check-in and throughout the entire study
- •Consumption of grapefruit and its juice and poppy containing foods for at least 72.00 hours prior to check-in and throughout the study.
结局指标
主要结局
1. To evaluate the oral bioavailability of investigational product (beta-alanine complex Plus liquid (400 mg)), reference product I Beta-alanine complex liquid (400 mg)) and reference product II (Conventional beta-alanine liquid (400 mg)) in healthy, adult, Human participants under fasting conditions.
时间窗: baseline and End of study.
次要结局
- To monitor the adverse events & to ensure the safety of the subjects.
研究者
Dr Ambanna Gowda
Unitree Health Care Diagnostics