Nirvana Super Pro Supplementation in Orthopedic Surgery Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
研究概览
简要总结
The purpose of this study is to investigate orthopedic patients undergoing either a total hip replacement (THR) or total knee arthroplasty (TKR) using two dietary supplements, PREPARE and RECOVER, and their recovery times post-surgery.
详细描述
This study involves two dietary supplements that have been formulated by Nirvana Water Sciences Corp for Super Inspired LLC. A pre-operative supplement, called PREPARE, has been created with HMB, Vitamin D, Selenium, Zinc, and Vitamin C to provide pre-operative nutrition, promote lean muscle development and boost immunity. A post-operative supplement, called RECOVER, has been created with HMB, collagen, L-citrulline, resveratrol, and 2-HOBA to help maintain lean muscle, support wound healing and reduce oxidative stress.
HMB or βeta-hydroxy βeta-methylbutyrate is a nutritional supplement that has been extensively studied for its potential benefits. It is a substance that your body naturally produces when it breaks down the amino acid leucine, which is essential for protein synthesis and muscle repair. There are over 50 human studies, 40 review articles and four meta-analyses showing its effectiveness and safety. These clinical studies provide evidence of the benefits of HMB and supports the claims that HMB boosts muscle performance, slows muscle degradation, and reduces muscle recovery time.
Muscle atrophy (loss of muscle mass) and poor muscle function are demonstrated in patients suffering from osteoarthritis (OA) involving several joints and particularly the hip and the knee joints. Several studies have shown that this atrophy is worsened in the immediate postoperative period, and complete recovery is not established up to 2 years postop. Little is known about muscular recovery after either total hip replacement (THR) or total knee arthroplasty (TKR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
盲法说明
Participants will be assigned a number and by the care provider staff prior to providing collecting data.
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects will be enrolled into the study.
- •Age ≥45-80 years.
- •Free of liver and kidney diseases, and with no evidence of uncontrolled hypertension.
- •Does not have a chronic disease that affects calcium or bone metabolism (i.e., asthma with chronic use of high dose steroids, inflammatory bowel disease, Crohn's disease, primary hyperparathyroidism, seizure disorder with use of phenobarbital, etc.).
- •Not classified as morbidly obese (body mass index (BMI) >43 kg/m2).
- •Six weeks since major surgery (three weeks since minor surgery).
- •Total joint replacement is not a revision of previous joint replacement.
- •Willing to consume dietary supplements for the study period.
- •Individuals diagnosed with osteoporosis, or a bone density >2.0 standard deviations below the mean, will not be enrolled in the study.
- •No other serious medical illness.
- •Physicians have placed no restriction on physical exercise.
- •Patient is scheduled for a total knee or hip replacement and agrees to consume the 28-day pre-operative regime.
排除标准
- •Evidence of liver and kidney diseases, uncontrolled hypertension, or Type I or II diabetes mellitus requiring insulin for glucose control.
- •The presence of a chronic disease that affects calcium or bone metabolism (i.e., asthma with chronic use of high dose steroids, inflammatory bowel disease, Crohn's disease, primary hyperparathyroidism, seizure disorder with use of phenobarbital, etc.).
- •Classified as morbidly obese (body mass index (BMI) >43 kg/m2).
- •Less than six weeks since major surgery or three weeks since minor surgery.
- •Surgery is a revision of a previous total joint replacement.
- •Not willing to consume nutritional supplements for the study period.
- •Individuals diagnosed with osteoporosis, or a bone density >2.0 standard deviations below the mean, will not be enrolled in the study.
- •Other serious medical illness, which the subject's doctor or medical review team has decided affects the subject's ability to participate in the study. For example, pathological hip fracture or cancer disease in active phase or undergoing treatment (radiotherapy or chemotherapy).
- •History of blood clots and/or the use of blood thinning medications
- •Subjects on high dose vitamin D therapies (i.e., 50,000 IU vitamin D).
结局指标
主要结局
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: 30+ days prior to surgery, 14-days after surgery, 28-30 days after surgery
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a questionnaire that measures the impact of osteoarthritis on pain, stiffness, and physical function in the hip or knee joints. It is a self-administered tool that consists of 24 items, each rated on a scale of 0 to 4, with higher scores indicating worse symptoms. The WOMAC is widely used in clinical trials and research studies to evaluate the effectiveness of treatments and interventions for osteoarthritis.
Grip Strength using a Jamar Hydraulic Hand Dynamometerer
时间窗: 30+ days prior to surgery, 14-days after surgery, 28-30 days after surgery
Grip Strength is a measure of the maximum force or tension generated by one's forearm muscles when gripping an object. A Jamar Hydraulic Hand Dynamometer is a device that can measure this force in pounds or kilograms. It is commonly used by physical therapists, occupational therapists, and hand surgeons to assess grip strength and monitor recovery or rehabilitation.
Timed Up & Go (TUG)
时间窗: 30+ days prior to surgery, 14-days after surgery, 28-30 days after surgery
The Timed Up and Go test or TUG test is used to help evaluate mobility. It is a simple test that measures how quickly one can stand up, walk 10 feet, turn around, walk back, and sit down. It is often done to assess mobility in older adults or predict their risk of falls.
次要结局
未报告次要终点