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

Phase 4

Completed

• Conditions: Knee Related Walking Limitations
• Interventions: Dietary Supplement: Rosehip; Dietary Supplement: Placebo

• Registration Number: NCT01927848
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-16
• Study First Submitted QC: 2013-08-20
• Study First Posted: 2013-08-23
• Study Start: 2013-09
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-14
• Last Update Posted: 2015-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rosehip	Rosehip	Dosage: 3 capsules once daily with meals (daily dose: 2.25 g powder).
Placebo	Placebo	Dosage: 3 capsules once daily with meals

Primary Outcome Measures

Name	Time	Method
Knee joint biomechanics during walking	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

Name	Time	Method
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	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.
Physician global assessment of patient disease	week 12	Physician's global assessment of overall health at clinical visits is scored on a 100 mm visual analogue scale (VAS)
Self-reported status of the participants' knee and associated problems	week 12	Knee Osteoarthritis and Injury Outcome Score (KOOS)
Self-reported health and well-being	week 12	Self-reported questionnaire.
Circulating levels of Alanine AminoTransferase (blood samples)	12 weeks
Circulating levels of Alkaline Phosphatase (blood samples)	12 weeks

Trial Locations

Locations (1)

The Parker Institute, Frederiksberg Hospital; 🇩🇰 Copenhagen, Denmark