Improving Gait in Persons With Knee Related Mobility Limitations by Rosenoids® Food Supplement: a Randomized Double-blind Placebo-controlled Trial

Study Overview
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Brief Summary
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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.

Conditions
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Knee Related Walking Limitations

Intervention / Treatment
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* Dietary Supplement: Rosehip
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged above 40 Self-reported knee-related walking disability In general good health, in the opinion of the Investigator, based on medical history and physical examination and, if necessary, laboratory values. Laboratory tests are prescribed by the Investigator at the screening visit. A body mass index (BMI) of ≤35 kg/m2 Speaks, reads and writes Danish language Exclusion Criteria: Usage of Rosehip nutritional supplements within the last 3 months History of symptoms of autoimmune disorders. Planned surgical procedure during the duration of the study History, diagnosis, or signs and symptoms of clinically significant neurological disease Alcohol or drug abuse within the last 5 years History, diagnosis, signs or symptoms of any clinically significant psychiatric disorder Subjects with regional pain syndromes suggestive of lumbar compressions with radiculopathy or at risk of developing radiculopathy. Any other condition, which in the opinion of the Investigator, would put the subject at increased safety risk or otherwise make the subject unsuitable for this study.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rosehip<br>Dosage: 3 capsules once daily with meals (daily dose: 2.25 g powder). | Dietary Supplement: Rosehip<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Dosage: 3 capsules once daily with meals | Dietary Supplement: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |