Clinical trial NCT06203691: Nirvana Super Pro Supplementation in Orthopedic Surgery Patients
Official title: Nirvana Super Pro Supplementation in Orthopedic Surgery Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arthropathy of Knee
Arthropathy of Hip
Keywords: Arthroplasties
Knee & Hip Replacement
Dietary Supplements
Lead sponsor: Super Inspired LLC
Sponsor class: INDUSTRY
First posted: 2024-01-12
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group will receive the supplements. The control group will not receive the supplements. All participants will undergo strength test - pre and post operatively.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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).

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 30+ days prior to surgery, 14-days after surgery, 28-30 days after surgery
measure: Timed Up & Go (TUG)
timeFrame: 30+ days prior to surgery, 14-days after surgery, 28-30 days after surgery
measure: Grip Strength using a Jamar Hydraulic Hand Dynamometerer
timeFrame: 30+ days prior to surgery, 14-days after surgery, 28-30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Altoona
country: United States
facility: University Orthopedics Center
state: Pennsylvania
Study officials:
affiliation: Nirvana Water Sciences Corp
name: Candice St. Pierre, Ph.D.
role: STUDY_CHAIR
References:
citation: Bear DE, Langan A, Dimidi E, Wandrag L, Harridge SDR, Hart N, Connolly B, Whelan K. beta-Hydroxy-beta-methylbutyrate and its impact on skeletal muscle mass and physical function in clinical practice: a systematic review and meta-analysis. Am J Clin Nutr. 2019 Apr 1;109(4):1119-1132. doi: 10.1093/ajcn/nqy373.
citation: Hiemstra LA, Gofton WT, Kriellaars DJ. Hip strength following hamstring tendon anterior cruciate ligament reconstruction. Clin J Sport Med. 2005 May;15(3):180-2. doi: 10.1097/01.jsm.0000157795.93004.ea.
citation: Nishizaki K, Ikegami H, Tanaka Y, Imai R, Matsumura H. Effects of supplementation with a combination of beta-hydroxy-beta-methyl butyrate, L-arginine, and L-glutamine on postoperative recovery of quadriceps muscle strength after total knee arthroplasty. Asia Pac J Clin Nutr. 2015;24(3):412-20. doi: 10.6133/apjcn.2015.24.3.01.
citation: Silva AM, Shen W, Heo M, Gallagher D, Wang Z, Sardinha LB, Heymsfield SB. Ethnicity-related skeletal muscle differences across the lifespan. Am J Hum Biol. 2010 Jan-Feb;22(1):76-82. doi: 10.1002/ajhb.20956.
citation: Wilkinson DJ, Hossain T, Hill DS, Phillips BE, Crossland H, Williams J, Loughna P, Churchward-Venne TA, Breen L, Phillips SM, Etheridge T, Rathmacher JA, Smith K, Szewczyk NJ, Atherton PJ. Effects of leucine and its metabolite beta-hydroxy-beta-methylbutyrate on human skeletal muscle protein metabolism. J Physiol. 2013 Jun 1;591(11):2911-23. doi: 10.1113/jphysiol.2013.253203. Epub 2013 Apr 3.
citation: Wu H, Xia Y, Jiang J, Du H, Guo X, Liu X, Li C, Huang G, Niu K. Effect of beta-hydroxy-beta-methylbutyrate supplementation on muscle loss in older adults: a systematic review and meta-analysis. Arch Gerontol Geriatr. 2015 Sep-Oct;61(2):168-75. doi: 10.1016/j.archger.2015.06.020. Epub 2015 Jul 3.