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Knee related mobility limitations are the leading cause of disability in the western world. It is a very expensive and debilitating condition when the cost of lost productivity and personal assistance is considered.
In recent years there has been a growing interest in alternative medicine and many individuals seek such treatments. Rosehip, that is sold as a nutritional supplement, has been particular popular, and has been shown effective in relieiving pain - albeit the evidence is scarce.
The purpose of this study is to evaluate the efficacy of specialized rosehip powder nutritional additives (Rosenoids®) on knee joint function during walking in subjects with knee-related walking limitations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosehip | Experimental | Dosage: 3 capsules once daily with meals (daily dose: 2.25 g powder). |
|
| Placebo | Placebo Comparator | Dosage: 3 capsules once daily with meals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosehip | Dietary Supplement | Rosehip powder made from the fleshy orange walls (hypanthiums) of Rosehips with the achenes (seeds) removed, from the wild growing species Dog Rose (Rosa canina L.), in addition to vitamin C as sodium ascorbate. The active ingredient complex is Rosenoids®, Vitamin C, flavonoids, carotens, triterpene acids, and galactolipids. Rosenoids® is the registered name for the bioactive complex isolated from the rose-hip (Rosa canina) used in RH01. It is being supplied as capsules containing 750 mg of the Rosehip powder and 26.7 mg vitamin C. |
| Measure | Description | Time Frame |
|---|---|---|
| Knee joint biomechanics during walking | 3-D kinematic gait data is obtained using a 6-camera Motion Analysis System sampling at 100 Hz capturing positions and movements of reflective markers placed on the skin and arranged in the Plug-in-Gait configuration. Ground reaction forces and moments are obtained with two 6-channel force platforms (Advanced Mechanical Technologies, Inc., Newton, MA, USA) operating at 1500 Hz synchronized with the camera system. Specialized software is used to generate lower extremity angular kinematic and kinetic data using inverse dynamics. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Circulating levels of C-reactive protein (blood samples) | 12 weeks | |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | A questionnaire with suggestive leading questions, assessing adverse events at large - not necessarily adverse effects in a generic framework using options based on standards applied previously is used. |
| Measure | Description | Time Frame |
|---|---|---|
| Capsule count | Number of capsules returned in relation to number of capsules provided. | week 12 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marius Henriksen, PhD | Parker Institute, Frederiksberg Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Parker Institute, Frederiksberg Hospital | Copenhagen | 2000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26234471 | Derived | Ginnerup-Nielsen E, Christensen R, Bliddal H, Zangger G, Hansen L, Henriksen M. Improved gait in persons with knee related mobility limitations by a rosehip food supplement: A randomized, double-blind, placebo-controlled trial. Gait Posture. 2015 Sep;42(3):340-7. doi: 10.1016/j.gaitpost.2015.07.001. Epub 2015 Jul 19. |
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| Placebo | Dietary Supplement | The placebo used in this study will be identical to the Rosehip capsules in both appearance and taste, except that it will not contain the active Rosehip powder ingredient Rosenoids® or vitamin C. |
|
| week 12 |
| Physician global assessment of patient disease | Physician's global assessment of overall health at clinical visits is scored on a 100 mm visual analogue scale (VAS) | week 12 |
| Self-reported status of the participants' knee and associated problems | Knee Osteoarthritis and Injury Outcome Score (KOOS) | week 12 |
| Self-reported health and well-being | Self-reported questionnaire. | week 12 |
| Circulating levels of Alanine AminoTransferase (blood samples) | 12 weeks |
| Circulating levels of Alkaline Phosphatase (blood samples) | 12 weeks |