Clinical trial NCT01927848: Improving Gait in Persons With Knee Related Mobility Limitations by Rosenoids® Food Supplement: a Randomized Double-blind Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Related Walking Limitations
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
First posted: 2013-08-23
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Knee joint biomechanics during walking
timeFrame: 12 weeks
Secondary outcomes:
measure: Circulating levels of C-reactive protein (blood samples)
timeFrame: 12 weeks
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: week 12
measure: Physician global assessment of patient disease
timeFrame: week 12
measure: Self-reported status of the participants' knee and associated problems
timeFrame: week 12
measure: Self-reported health and well-being
timeFrame: week 12
measure: Circulating levels of Alanine AminoTransferase (blood samples)
timeFrame: 12 weeks
measure: Circulating levels of Alkaline Phosphatase (blood samples)
timeFrame: 12 weeks
Other outcomes:
measure: Capsule count
timeFrame: week 12
Locations:
city: Copenhagen
country: Denmark
facility: The Parker Institute, Frederiksberg Hospital
Study officials:
affiliation: Parker Institute, Frederiksberg Hospital
name: Marius Henriksen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.