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Effect of Collagen Hydrolysate in Articular Pain: A 6-Month Randomized, Double-Blind, Placebo Controlled Study

Olivier Bruyère, Bernard Zegels, Lucio Leonori, Véronique Rabenda, Audrey Janssen, Cécile Bourges, Jean-Yves Reginster
Complementary Therapies in Medicine 2012 20(3):124-130

Bibliography

PubMed
PMID 22500661
DOI
10.1016/j.ctim.2011.12.007
Funding
This study was supported by a research grant from Nutraveris. Nutraveris (France) markets the GENACOL collagen hydrolysate product tested in the trial; co-author Cécile Bourges is affiliated with Nutraveris. Biohack Blueprint assessment: the funder and a co-author are directly commercially tied to the tested product (GENACOL). This is a manufacturer-sponsored trial of the manufacturer's own product, which should be weighed when interpreting the modest, borderline result.
Competing interests
O. Bruyère receives grants or has been reimbursed for attending meetings from GlaxoSmithKline, IBSA, MSD, Novartis, Rottapharm, Servier, Theramex and Wyeth, and gives advice to food-safety agencies. J.-Y. Reginster has received consulting fees, speaker fees or grant support from numerous pharmaceutical companies (listed in full in the published article). Other authors declare no conflict of interest.

Study snapshot

DesignRandomised, double-blind, placebo-controlled, multicentre, parallel-group trial
ModelAmbulatory adults aged ≥50 years with joint pain (hip, knee, elbow, shoulder, hand and/or lumbar spine) of at least 30 mm on a 100 mm visual analogue scale (VAS)
Samplen=200 randomised (100 collagen hydrolysate, 100 placebo); n=144 completed the 6-month study (67 collagen, 77 placebo)
InterventionCollagen hydrolysate (GENACOL) 1200 mg/day (3 hard gel capsules) vs matching placebo capsules, for 6 months
Duration6 months (24 weeks), with assessments at baseline, 3 months and 6 months
EndpointsProportion of clinical VAS responders (≥20% improvement in most painful joint); Lequesne index (hip/knee); DASH score (upper limb); EIFEL questionnaire (spine); EQ-5D and SF-36 quality of life; Adverse events

What the study showed, in plain terms

This trial tested a low daily dose — 1200 mg — of collagen hydrolysate against placebo in adults over 50 with joint pain from mixed causes and locations, over 6 months. That dose is noticeably lower than the 2.5-15 g doses used in most other joint-pain collagen trials in this corpus.

By the simple measure the trial was built around — a 20% or greater improvement on a pain visual analogue scale — significantly more people improved on collagen (51.6%) than placebo (36.5%) at 6 months. But that difference wasn't there yet at 3 months, and it didn't show up on any of the more specific, validated pain and function questionnaires (Lequesne, DASH, EIFEL) used as secondary measures.

Read alongside the funding disclosure — a manufacturer grant and a co-author employed by the company selling the product — this is best treated as a modest, unreplicated signal at a below-typical dose, not confirmatory evidence of a clinically meaningful joint-pain benefit.

Key findings

  • At 6 months, 51.6% of the collagen group were VAS responders (≥20% pain improvement) vs 36.5% of the placebo group (p<0.05).
  • At 3 months, the difference in responder rate was not statistically significant (44.1% collagen vs 39.6% placebo, p=0.53).
  • No statistically significant between-group difference was found on the Lequesne index, DASH score, or EIFEL questionnaire — the validated joint-specific instruments used as secondary outcomes.
  • No significant difference in EQ-5D utility scores or any SF-36 quality-of-life dimension between groups.
  • No significant difference in adverse events, serious adverse events, or treatment-related adverse events between collagen and placebo.
  • Drop-out was higher in the collagen group (33%) than placebo (23%), driven partly by more inefficacy withdrawals in the collagen arm.

What this study can and cannot tell us

  • The primary VAS-responder benefit was not confirmed on any of the three validated, joint-specific secondary questionnaires (Lequesne, DASH, EIFEL) — a pattern that weakens confidence in a true clinical effect.
  • The tested dose (1200 mg/day) is well below the 2.5-15 g/day range used in most other collagen-and-joint-pain trials, making it hard to compare directly with the rest of this corpus.
  • Manufacturer research grant funding and a co-author employed by the company selling the tested product (Nutraveris/GENACOL) are direct commercial interests relevant to interpreting a borderline primary result.
  • No diagnostic confirmation (e.g. imaging) of the underlying joint condition was required — participants were included on symptom criteria alone, so the population is heterogeneous (osteoarthritis, non-specific joint pain, and other causes pooled together).
  • Drop-out was substantial (28% overall, higher in the collagen arm), and intent-to-treat analysis used last-observation-carried-forward, which can understate a true effect if drop-outs were disproportionately non-responders.

Related papers in the corpus

Tier 2
24-Week study on the use of collagen hydrolysate as a dietary supplement in athletes with activity-related joint pain
Kristine L. Clark et al. · Current Medical Research and Opinion · 2008
Tier 2
A randomized controlled trial on the efficacy and safety of a food ingredient, collagen hydrolysate, for improving joint comfort
P. Benito-Ruiz et al. · International Journal of Food Sciences and Nutrition · 2009

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Dr. Khaled Mahmoud, MBBChCritical Care Medicine, Longevity Science & Editorial Direction Dr. Amr Yasser, PhDCardiometabolic, Musculoskeletal, Gut & Bioavailability Dr. Abdulla Mostafa, PhDCellular Senescence, Neurological, Mitochondrial & Brain-Ageing Biology