Condition category
Musculoskeletal Diseases
Date applied
01/02/2010
Date assigned
22/02/2010
Last edited
12/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Joint pain is a major cause of disability in subjects aged over 50 years. Symptomatic pain relief can be obtained with painkillers such as paracetamol or non-steroidal anti-inflammatory drugs. These treatments, while generally safe when used at low doses and for a short time, can result in serious complications (gastrointestinal bleeding, kidney failure, coronary heart disease) when used for a long time or at higher doses and could obviously reduce the adherence to treatment. In subjects with joint symptoms, food supplements are often taken by patients with the aim to relieve pain and improve physical function. GENACOL®, a food supplement made of collagen hydrolysate, is a food supplement that claims to improve joint symptoms. The aim of this study is to assess whether taking this food supplement over 24 weeks increases the number of subjects with an improvement in joint pain and/or physical function symptoms.

Who can participate?
Men and women aged over 50 years with joint pain (hip, knee, elbow, shoulder, hand and/or lumbar spine).

What does the study involve?
Subjects were randomly allocated to receive either GENACOL® (three hard gel capsules per day) or a dummy/placebo (identical hard gel capsules, to be consumed in the same daily dosage). The target joint that was followed-up throughout the study was the most painful joint at the first visit. As the product tested is a food supplement, no accurate diagnosis of joint pain was performed.

What are the possible benefits and risks of participating?
A reduction of joint pain is expected in the GENACOL group. No specific risk is expected as this product is already marketed without significant adverse events.

Where is the study run from?
University of Liège (Belgium).

When is the study starting and how long is it expected to run for?
The study started in July 2009 and finished in January 2011.

Who is funding the study?
The study was financed by Nutraveris (France).

Who is the main contact?
Prof Jean-Yves Reginster
jyreginster@ulg.ac.be

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jean-Yves Reginster

ORCID ID

Contact details

University of Liège
CHU Sart Tilman Bat B23
Liege
4000
Belgium

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NUTRA-CH-01

Study information

Scientific title

A randomised, double-blind, placebo-controlled phase IV trial to assess the clinical benefit of Genacol®, a food supplement made of a proprietary collagen hydrolysate (1200 mg/day), over a period of 24 weeks, in subjects with joint pain at the lower, upper limbs or at the lumbar spine

Acronym

Study hypothesis

Genacol® is a food supplement made of a proprietary collagen hydrolysate already registered, as food supplement, in various countries, including Belgium, Canada, France, the United Kingdom, Spain, Italy, the United States, and others. The aim of this supplementation is to reduce pain and reduce functional disabilities in subjects with joint pain.

On 12/08/2013, the anticipated end date was changed from 01/07/2010 to 01/01/2011.

Ethics approval

The Ethics Committee of Liege CHU approved on 17/06/2009 (ref: B70720096310)

Study design

Randomised double blind placebo controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet.

Condition

Joint pain

Intervention

Participants will be randomised to receive
1. Genacol®
Active ingredient: Collagene hydrolysate (400 mg/capsule; 1200 mg/day)
2. Placebo
Main ingredient: maltodextrin (400 mg/capsule; 1200 mg/day)
Participants will be required to take three hard gel capsules once daily before bed during the entire study period (24 weeks)

Intervention type

Other

Phase

Phase IV

Drug names

Primary outcome measures

Percentage of clinical responders between the active treatment and placebo groups

Secondary outcome measures

Outcomes will be evaluated at weeks 12 and 24
1. Pain rescue treatment consumption
2. Pain/function changes; assessed by
2.1. Visual analogue scale (VAS)
2.2. Lequesne index
2.3. Disability of Arm Shoulder and Hand (DASH) score
2.4. Functional Disability Scale for the Assessment of Low Back Pain (Echelle d'Incapacité Fonctionnelle pour l'Evaluation des Lombalgies [EIFEL]) questionnaire
3. Health-related quality of life changes; assessed with the SF-36
4. Utility value changes; assessed by EQ-5D
5. Tolerability and incidence of any adverse events
6. Global satisfaction of the treatment will be assessed by mean of a global questionnaire (also at week 4)

Overall trial start date

01/07/2009

Overall trial end date

01/01/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Men and women over 50 years with joint pain (hip, knee, elbow, shoulder, hand and lumbar spine) over 30 mm on a 0-100 mm visual analogue scale.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Unlikely to cooperate in the study
2. Poor compliance anticipated by the investigator
3. Participating in another trial at the same time or within the previous 1 month with active therapeutic intervention (except if the patient only performed the screening visit without taking the tested supplement)

Recruitment start date

01/07/2009

Recruitment end date

01/01/2011

Locations

Countries of recruitment

Belgium

Trial participating centre

University of Liège
Liege
4000
Belgium

Sponsor information

Organisation

Nutraveris (France)

Sponsor details

Nutraveris
18 C
rue du Sabot
Ploufragan
22440
France

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Nutraveris (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22500661

Publication citations

  1. Results

    Bruyère O, Zegels B, Leonori L, Rabenda V, Janssen A, Bourges C, Reginster JY, Effect of collagen hydrolysate in articular pain: a 6-month randomized, double-blind, placebo controlled study., Complement Ther Med, 2012, 20, 3, 124-130, doi: 10.1016/j.ctim.2011.12.007.

Additional files

Editorial Notes