Using dietary supplements to aid recovery in orthopedic surgery patients
Nirvana Super Pro Supplementation in Orthopedic Surgery Patients
This study tests if two dietary supplements can help people aged 45-80 recover faster after hip or knee replacement surgeries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 45 Years to 80 Years |
| Sex | All |
| Sponsor | Super Inspired LLC Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Altoona, Pennsylvania) |
| Trial ID | NCT06203691 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of two dietary supplements, PREPARE and RECOVER, on recovery times for patients undergoing total hip or knee replacement surgeries. PREPARE is designed to enhance pre-operative nutrition and immunity, while RECOVER aims to support muscle maintenance and wound healing post-surgery. Participants will be divided into groups receiving the supplements or not, allowing for a comparison of recovery outcomes. The study focuses on patients aged 45-80 who meet specific health criteria and are scheduled for joint replacement surgery.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 45-80 who are scheduled for total knee or hip replacement and meet specific health criteria.
Not a fit: Patients with osteoporosis or significant chronic diseases affecting bone metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery times and outcomes for patients undergoing orthopedic surgeries.
How similar studies have performed: Previous studies have shown positive outcomes with HMB supplementation in muscle recovery, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Altoona, Pennsylvania
- University Orthopedics Center — Altoona, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Candice St. Pierre, Ph.D.
- Email: candice@feelsuper.pro
- Phone: 864-567-0362
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.