Nirvana Super Pro Supplementation in Orthopedic Surgery Patients

Super Inspired LLC

Status: Enrolling

Conditions: Arthropathy of Hip; Arthropathy of Knee

Treatments: Dietary Supplement: Non-Supplementation Group; Dietary Supplement: Supplementation with Nirvana Super Pro Liquid Supplements

Study type: Interventional

Funder types: Industry

Identifiers

NCT06203691

11495

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 100 estimated patients

Sex: All

Ages: 45 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

Supplement Group

Experimental group

Description:

50 of the 100 participants will be given supplements (Prepare \& Recover) for pre \& post operation.

Treatment:

Dietary Supplement: Supplementation with Nirvana Super Pro Liquid Supplements

Non-Supplement Group

Placebo Comparator group

Description:

No supplements will be given to the non-supplement group.

Treatment:

Dietary Supplement: Non-Supplementation Group