Nirvana Super Pro Supplementation in Orthopedic Surgery Patients

NCT06203691 | Recruiting

• 1 other identifier: 11495
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthropathy of Knee; Arthropathy of Hip

Keywords

Arthroplasties; Knee & Hip Replacement; Dietary Supplements

Outcome Measures

Primary Outcomes (3)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  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.

  30+ days prior to surgery, 14-days after surgery, 28-30 days after surgery

• Timed Up & Go (TUG)

  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.

  30+ days prior to surgery, 14-days after surgery, 28-30 days after surgery

• Grip Strength using a Jamar Hydraulic Hand Dynamometerer

  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.

  30+ days prior to surgery, 14-days after surgery, 28-30 days after surgery

Study Arms (2)

Supplement Group

EXPERIMENTAL

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

Dietary Supplement: Supplementation with Nirvana Super Pro Liquid Supplements

Non-Supplement Group

PLACEBO COMPARATOR

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

Dietary Supplement: Non-Supplementation Group

Interventions

Supplementation with Nirvana Super Pro Liquid Supplements DIETARY_SUPPLEMENT

Intervention will measure strength pre \& post operatively. Intervention group will receive liquid supplements (3oz daily shots) pre (Prepare) and Post (Recover) operatively.

Supplement Group

Non-Supplementation Group DIETARY_SUPPLEMENT

Intervention will measure strength pre \& post operatively. Intervention group will not receive liquid supplements.

Also known as: Control Group

Non-Supplement Group

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Nirvana Water Sciences Corp: lead

Study Sites (1)

University Orthopedics Center

Altoona, Pennsylvania, 16602, United States

RECRUITING

Related Publications (6)

• 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.

  PMID: 30982854 BACKGROUND

• 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.

  PMID: 15867563 BACKGROUND

• 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.

  PMID: 26420181 BACKGROUND

• 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.

  PMID: 19533617 BACKGROUND

• 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.

  PMID: 23551944 BACKGROUND

• 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.

  PMID: 26169182 BACKGROUND

MeSH Terms

Interventions

Dietary Supplements; Control Groups

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Candice St. Pierre, Ph.D.

  Nirvana Water Sciences Corp

  STUDY CHAIR

Central Study Contacts

Candice St. Pierre, Ph.D.

CONTACT

864-567-0362; candice@feelsuper.pro

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Participants will be assigned a number and by the care provider staff prior to providing collecting data.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: One group will receive the supplements. The control group will not receive the supplements. All participants will undergo strength test - pre and post operatively.

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 12, 2024
• Study Start: February 21, 2024
• Primary Completion: June 30, 2024
• Study Completion: August 30, 2024
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available for 2 months for statistical analysis.
• Access Criteria: Data will be securely shared and only masked participant data will be shared with researchers.

Locations

US (1)