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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Knee Related Walking Limitations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Rosehip

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

Group Type EXPERIMENTAL

Rosehip

Intervention Type 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.

Placebo

Dosage: 3 capsules once daily with meals

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No