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

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.

Study Overview

• Status: Completed
• Conditions: Knee Related Walking Limitations
• Intervention / Treatment: Dietary supplement: Rosehip; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2000
    • The Parker Institute, Frederiksberg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Capsule count	Number of capsules returned in relation to number of capsules provided.	week 12

Collaborators and Investigators

• Sponsor: Frederiksberg University Hospital
• Investigators: Principal Investigator: Marius Henriksen, PhD, Parker Institute, Frederiksberg Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: August 16, 2013
• First Submitted That Met QC Criteria: August 20, 2013
• First Posted (Estimate): August 23, 2013

Study Record Updates

• Last Update Posted (Estimate): January 15, 2015
• Last Update Submitted That Met QC Criteria: January 14, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 127 (Tumor Vaccine Group)