Assessing the clinical benefit of food supplement, Genecol®, in subjects with joint pain at the lower, upper limbs or at the lumbar spine

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN76960238

Enrollment

200

Registered

2010-02-22

Start date

2009-07-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Joint pain Musculoskeletal Diseases Other joint disorders, not elsewhere classified

Interventions

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)

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Percentage of clinical responders between the active treatment and placebo groups	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Belgium

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026