Effects of Chicken Extract and Collagen on Mobility
Condition: Knee Osteoarthritis; Muscle Loss
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, double-blind placebo-controlled trial to study the effects of chicken extract
      and collagen on join, bone and muscle functions in comparison to an active comparator
      glucosamine
    

Detailed description: 
      Osteoarthritis (OA) of the knee, which entails the destruction of knee cartilage and
      remodeling of the adjacent bone, is one of the leading causes of disability among elderly
      adults. Consequences of severe knee OA, including loss of mobility and limited daily
      activities, affect individuals and society economically. The World Health Organization (WHO)
      Global Burden of Disease Study, conducted in 21 epidemiological regions worldwide, reported a
      26.6% increase in the burden of knee OA from 1990 to 2010.

      Current therapies for OA include various over the counter analgesics, a number of
      non-steroidal anti-inflammatory drugs (NSAIDs), intra-articular injections of corticosteroids
      or hyaluronic acid, plus tramadol and other opioid analgesics to relieve severe pain. , While
      these therapies can alleviate symptoms in the near term, their ultimate impact on the
      pathophysiologic progression of OA is limited. In addition, there are considerable side
      effects associated with the use of these drugs. Total joint replacement is typically the
      final and only effective solution for relieving pain and disability.

      As a result, OA sufferers always turn to natural nutraceuticals to ease their pain and
      discomfort. These products are commonly used because they are well tolerated and considered
      safe. Nutraceuticals are defined as functional foods, natural products, or parts of food that
      provide medicinal, therapeutic, or health benefits, including the prevention or treatment of
      disease. Currently, glucosamine and chondroitin are the two most commonly used nutraceuticals
      in humans to alleviate pain associated with arthritis. However, recent randomized controlled
      trials and meta-analysis of these supplements have shown only small-to-moderate symptomatic
      efficacy in OA.

      It therefore seems appropriate to explore other natural supplements/ingredients. There is
      growing interest in hydrolyzed collagen (or collagen hydrolysate [CH]) as a nutraceutical
      supplement because collagen-derived peptides harbor a variety of interesting biological
      properties. CH has been found to down-regulate inflammatory markers involved in joint
      inflammation and cartilage degradation such as interleukins (ILs), IL-6, IL-7, IL-9 and IL-12
      as well as monocyte-chemoattractant-1 (MCP-1) in chondrocytes induced with IL-1 beta. In
      addition, CH reduces bone resorption in an in vitro model for regulation of osteoclastic
      differentiation and bone resorption by RANKL system (unpublished data).

      CH has received considerable attention in relieving OA-associated symptoms. The hypothesis of
      how CH may reduce OA-associated symptoms includes providing bioavailable substrate (building
      blocks) for the collagen fibrillar network, which provides tensile strength for the matrix of
      articular cartilage. Oesser et al. in a series of preclinical studies, demonstrated that CH
      passes across the mucosal barrier in the small bowel as a complete peptide that is no longer
      subject to enzymatic cleavage, accumulates in cartilage tissue, and stimulates production of
      type II collagen (the major protein in articular cartilage) and proteoglycans in the
      extracellular matrix of cartilage. , , In addition to these preclinical studies, open label,
      comparative, and prospective, randomized, placebo-controlled clinical trials and experimental
      findings have been published, with several studies providing evidence of a beneficial effect
      on measurements of joint health from the administration of collagen hydrolysate in a variety
      of patient populations, mostly OA patients. , , , , , CH per day for 3 months produced an
      improvement in joint health or function, such as reduction in pain,11,12,14 decreased
      dependency on pain medications,14 and improvement in leg strength.16 Given these
      observations, the investigators develop a supplementation of chicken essence with additive of
      CH-Brands Essence of Chicken plus CH (BEC-CH). The CH is derived from chicken cartilage. It
      is a soluble naturally occurring matrix of hydrolyzed collagen type II, chondroitin sulfate,
      and hyaluronic acid. The composition is similar to that of the human articular cartilage
      lining found in the synovial joints. Regarding BEC, it has been consumed for decades as a
      health tonic for energy boosting and fatigue recovery. In fact, BEC supplementation has been
      clinically proven to accelerate the recovery from exercise by increasing the rate of
      clearance of plasma lactate and ammonia and hence reduces muscle fatigue. However, all of
      these data are based on supplementation of either BEC of CH per se in clinical or in in vitro
      settings. Thus, it is crucial to investigate the efficacy of both BEC and CH when taken in
      combination on joint, bone, and muscle function. To answer these questions and to investigate
      its tolerability and efficacy, this randomized, double-blind, four-arm pilot study is thus
      carried out. It is hypothesized that supplementation with BEC-CH might relieve joint
      discomfort, restore joint function, and also be beneficial to bone and muscle.
    

Intervention name(s): Collagen hydrolysate and chicken extract
Intervention type(s): Dietary Supplement
Intervention description(s): One bottle (68mL) of collagen hydrolysate (2g) in chicken extract taken daily in the morning after meal for 24 weeks
Other intervention name(s): BRAND'S chicken extract
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Randomized, Double-blind, Four-arm Pilot Study to Evaluate the Effects of Brands Chicken Extract and Collagen on Joint, Bone, and Muscle Functions
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care