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

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ClinicalTrials.gov Identifier: NCT01927848
Recruitment Status : Completed
First Posted : August 23, 2013
Last Update Posted : January 15, 2015
Sponsor:
Information provided by (Responsible Party):
Marius Henriksen, Frederiksberg University Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Knee Related Walking Limitations Dietary Supplement: Rosehip Dietary Supplement: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Arm Intervention/treatment
Experimental: Rosehip
Dosage: 3 capsules once daily with meals (daily dose: 2.25 g powder).
Dietary Supplement: Rosehip
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.

Placebo Comparator: Placebo
Dosage: 3 capsules once daily with meals
Dietary Supplement: Placebo
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.




Primary Outcome Measures :
  1. Knee joint biomechanics during walking [ Time Frame: 12 weeks ]
    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.


Secondary Outcome Measures :
  1. Circulating levels of C-reactive protein (blood samples) [ Time Frame: 12 weeks ]
  2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: week 12 ]
    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.

  3. Physician global assessment of patient disease [ Time Frame: week 12 ]
    Physician's global assessment of overall health at clinical visits is scored on a 100 mm visual analogue scale (VAS)

  4. Self-reported status of the participants' knee and associated problems [ Time Frame: week 12 ]
    Knee Osteoarthritis and Injury Outcome Score (KOOS)

  5. Self-reported health and well-being [ Time Frame: week 12 ]
    Self-reported questionnaire.

  6. Circulating levels of Alanine AminoTransferase (blood samples) [ Time Frame: 12 weeks ]
  7. Circulating levels of Alkaline Phosphatase (blood samples) [ Time Frame: 12 weeks ]

Other Outcome Measures:
  1. Capsule count [ Time Frame: week 12 ]
    Number of capsules returned in relation to number of capsules provided.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01927848


Locations
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Denmark
The Parker Institute, Frederiksberg Hospital
Copenhagen, Denmark, 2000
Sponsors and Collaborators
Frederiksberg University Hospital
Investigators
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Principal Investigator: Marius Henriksen, PhD Parker Institute, Frederiksberg Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marius Henriksen, Senior Researcher, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT01927848    
Other Study ID Numbers: 127
First Posted: August 23, 2013    Key Record Dates
Last Update Posted: January 15, 2015
Last Verified: January 2015