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

NCT01927848 | Completed Phase 4

• 1 other identifier: 127
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Related Walking Limitations

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Circulating levels of C-reactive protein (blood samples)

  12 weeks

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  week 12

• Physician global assessment of patient disease

  week 12

• Self-reported status of the participants' knee and associated problems

  week 12

• Self-reported health and well-being

  week 12

Other Outcomes (1)

• Capsule count

  week 12

Study Arms (2)

Rosehip

EXPERIMENTAL

Dosage: 3 capsules once daily with meals (daily dose: 2.25 g powder).

Dietary Supplement: Rosehip

Placebo

PLACEBO COMPARATOR

Dosage: 3 capsules once daily with meals

Dietary Supplement: Placebo

Interventions

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.

Rosehip

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.

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Frederiksberg University Hospital: lead

Study Sites (1)

The Parker Institute, Frederiksberg Hospital

Copenhagen, 2000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 26234471 DERIVED

Study Officials

• Marius Henriksen, PhD

  Parker Institute, Frederiksberg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: August 16, 2013
• First Posted: August 23, 2013
• Study Start: September 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 15, 2015

Record last verified: 2015-01

Locations

DK (1)