<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04483024</url>
  </required_header>
  <id_info>
    <org_study_id>BEC-CH-001</org_study_id>
    <nct_id>NCT04483024</nct_id>
  </id_info>
  <brief_title>Effects of Chicken Extract and Collagen on Mobility</brief_title>
  <official_title>A Randomized, Double-blind, Four-arm Pilot Study to Evaluate the Effects of BRAND'S Chicken Extract and Collagen on Joint, Bone and Muscle Functions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shan May Yong</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cerebos Pacific Limited</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized, double-blind placebo-controlled trial to study the effects of chicken extract&#xD;
      and collagen on join, bone and muscle functions in comparison to an active comparator&#xD;
      glucosamine&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Osteoarthritis (OA) of the knee, which entails the destruction of knee cartilage and&#xD;
      remodeling of the adjacent bone, is one of the leading causes of disability among elderly&#xD;
      adults. Consequences of severe knee OA, including loss of mobility and limited daily&#xD;
      activities, affect individuals and society economically. The World Health Organization (WHO)&#xD;
      Global Burden of Disease Study, conducted in 21 epidemiological regions worldwide, reported a&#xD;
      26.6% increase in the burden of knee OA from 1990 to 2010.&#xD;
&#xD;
      Current therapies for OA include various over the counter analgesics, a number of&#xD;
      non-steroidal anti-inflammatory drugs (NSAIDs), intra-articular injections of corticosteroids&#xD;
      or hyaluronic acid, plus tramadol and other opioid analgesics to relieve severe pain. , While&#xD;
      these therapies can alleviate symptoms in the near term, their ultimate impact on the&#xD;
      pathophysiologic progression of OA is limited. In addition, there are considerable side&#xD;
      effects associated with the use of these drugs. Total joint replacement is typically the&#xD;
      final and only effective solution for relieving pain and disability.&#xD;
&#xD;
      As a result, OA sufferers always turn to natural nutraceuticals to ease their pain and&#xD;
      discomfort. These products are commonly used because they are well tolerated and considered&#xD;
      safe. Nutraceuticals are defined as functional foods, natural products, or parts of food that&#xD;
      provide medicinal, therapeutic, or health benefits, including the prevention or treatment of&#xD;
      disease. Currently, glucosamine and chondroitin are the two most commonly used nutraceuticals&#xD;
      in humans to alleviate pain associated with arthritis. However, recent randomized controlled&#xD;
      trials and meta-analysis of these supplements have shown only small-to-moderate symptomatic&#xD;
      efficacy in OA.&#xD;
&#xD;
      It therefore seems appropriate to explore other natural supplements/ingredients. There is&#xD;
      growing interest in hydrolyzed collagen (or collagen hydrolysate [CH]) as a nutraceutical&#xD;
      supplement because collagen-derived peptides harbor a variety of interesting biological&#xD;
      properties. CH has been found to down-regulate inflammatory markers involved in joint&#xD;
      inflammation and cartilage degradation such as interleukins (ILs), IL-6, IL-7, IL-9 and IL-12&#xD;
      as well as monocyte-chemoattractant-1 (MCP-1) in chondrocytes induced with IL-1 beta. In&#xD;
      addition, CH reduces bone resorption in an in vitro model for regulation of osteoclastic&#xD;
      differentiation and bone resorption by RANKL system (unpublished data).&#xD;
&#xD;
      CH has received considerable attention in relieving OA-associated symptoms. The hypothesis of&#xD;
      how CH may reduce OA-associated symptoms includes providing bioavailable substrate (building&#xD;
      blocks) for the collagen fibrillar network, which provides tensile strength for the matrix of&#xD;
      articular cartilage. Oesser et al. in a series of preclinical studies, demonstrated that CH&#xD;
      passes across the mucosal barrier in the small bowel as a complete peptide that is no longer&#xD;
      subject to enzymatic cleavage, accumulates in cartilage tissue, and stimulates production of&#xD;
      type II collagen (the major protein in articular cartilage) and proteoglycans in the&#xD;
      extracellular matrix of cartilage. , , In addition to these preclinical studies, open label,&#xD;
      comparative, and prospective, randomized, placebo-controlled clinical trials and experimental&#xD;
      findings have been published, with several studies providing evidence of a beneficial effect&#xD;
      on measurements of joint health from the administration of collagen hydrolysate in a variety&#xD;
      of patient populations, mostly OA patients. , , , , , CH per day for 3 months produced an&#xD;
      improvement in joint health or function, such as reduction in pain,11,12,14 decreased&#xD;
      dependency on pain medications,14 and improvement in leg strength.16 Given these&#xD;
      observations, the investigators develop a supplementation of chicken essence with additive of&#xD;
      CH-Brands Essence of Chicken plus CH (BEC-CH). The CH is derived from chicken cartilage. It&#xD;
      is a soluble naturally occurring matrix of hydrolyzed collagen type II, chondroitin sulfate,&#xD;
      and hyaluronic acid. The composition is similar to that of the human articular cartilage&#xD;
      lining found in the synovial joints. Regarding BEC, it has been consumed for decades as a&#xD;
      health tonic for energy boosting and fatigue recovery. In fact, BEC supplementation has been&#xD;
      clinically proven to accelerate the recovery from exercise by increasing the rate of&#xD;
      clearance of plasma lactate and ammonia and hence reduces muscle fatigue. However, all of&#xD;
      these data are based on supplementation of either BEC of CH per se in clinical or in in vitro&#xD;
      settings. Thus, it is crucial to investigate the efficacy of both BEC and CH when taken in&#xD;
      combination on joint, bone, and muscle function. To answer these questions and to investigate&#xD;
      its tolerability and efficacy, this randomized, double-blind, four-arm pilot study is thus&#xD;
      carried out. It is hypothesized that supplementation with BEC-CH might relieve joint&#xD;
      discomfort, restore joint function, and also be beneficial to bone and muscle.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">December 1, 2019</completion_date>
  <primary_completion_date type="Actual">October 31, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in WOMAC scores from baseline</measure>
    <time_frame>6 months</time_frame>
    <description>knee joint pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Visual Analgoue Scale (VAS) pain scores from baseline</measure>
    <time_frame>14 days</time_frame>
    <description>knee joint pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Bone mass from baseline</measure>
    <time_frame>6 months</time_frame>
    <description>Lumbar spine, left and right hip</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Handgrip strength from baseline</measure>
    <time_frame>6 months</time_frame>
    <description>Average of both hands</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <condition>Muscle Loss</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Maltodextrin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glucosamine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Glucosamine hydrochloride</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Collagen hydrolysate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2g of hydrolyzed collagen II</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Collagen hydrolysate + chicken extract</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2g of hydrolyzed collagen II with chicken extract</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Collagen hydrolysate and chicken extract</intervention_name>
    <description>One bottle (68mL) of collagen hydrolysate (2g) in chicken extract taken daily in the morning after meal for 24 weeks</description>
    <arm_group_label>Collagen hydrolysate</arm_group_label>
    <arm_group_label>Collagen hydrolysate + chicken extract</arm_group_label>
    <arm_group_label>Glucosamine</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>BRAND'S chicken extract</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male/female at 45 - 75 years of age&#xD;
&#xD;
          2. Subject has a body mass index range of 18.0 to 30.0 kg/m2, inclusive, and weighs at&#xD;
             least 40 kg at screening&#xD;
&#xD;
          3. Subject agrees not to participate in another interventional study while participating&#xD;
             in the present study, defined as signing the informed consent form until completion of&#xD;
             the study.&#xD;
&#xD;
          4. Experience knee pain ≥ 3 months&#xD;
&#xD;
          5. WOMAC total pain score ≥ 6 evaluated by walking on a flat surface, descending and/or&#xD;
             ascending stairs&#xD;
&#xD;
          6. Subject has mild-to-moderate knee osteoarthritis (OA) at grade 1 - 3 per&#xD;
             Kellgren-Lawrence grading system&#xD;
&#xD;
          7. Experience loss in muscular strength or physical performance greater than 1 year&#xD;
&#xD;
          8. Be willing to refrain from hormone therapy and dietary supplements such as calcium,&#xD;
             vitamin D, supplements enriched with proteins, omega-3, omega-6, glucosamine, or&#xD;
             chondroitin during the entire study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inability to participate in the evaluation of the study&#xD;
&#xD;
          2. Active viral infection or bacterial infection based on clinical observations&#xD;
&#xD;
          3. Subjects with history of rheumatoid arthritis or any other inflammatory arthritis&#xD;
&#xD;
          4. Chronic medical conditions including renal dysfunctions, psychiatric disorders, or&#xD;
             diabetes (or HbA1c &gt; 6.5%)&#xD;
&#xD;
          5. History of stroke or myocardial infarction, mental retardation, or schizophrenia&#xD;
&#xD;
          6. Gout&#xD;
&#xD;
          7. Paget disease of bone or spinal disc herniation&#xD;
&#xD;
          8. Subjects intolerant or allergic to protein-based food or supplement&#xD;
&#xD;
          9. Anti-osteoporotic therapy in the past year&#xD;
&#xD;
         10. Intra-articular injection during previous 3 months (6 months for hyaluronic acid)&#xD;
             applied at target knee joint (most painful knee joint at Screening visit)&#xD;
&#xD;
         11. Current corticosteroid therapy&#xD;
&#xD;
         12. Those expecting knee arthroscopy or arthroplasty&#xD;
&#xD;
         13. Life-threatening pathology (such as cancer) in remission for less than 1 year or still&#xD;
             ongoing&#xD;
&#xD;
         14. Psychological or linguistic incapability to sign the informed consent&#xD;
&#xD;
         15. History of allergy to chicken meat&#xD;
&#xD;
         16. Pregnant or lactating women&#xD;
&#xD;
         17. Suspected or known alcohol abuse or addiction (consume ≥ 14 drinks of alcohol per&#xD;
             week; 1 drink: ~355-mL beer or 150-mL wine)&#xD;
&#xD;
         18. Subjects with any other conditions or diseases that investigator considers not&#xD;
             appropriate to be entered in the study&#xD;
&#xD;
         19. Subjects with active pathology that could confound interpretation of knee pain or any&#xD;
             conditions that interfere with adherence&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hsin-Nung Shih, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Linkou Chang Gung Memorial Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cerebos Pacific Limited</investigator_affiliation>
    <investigator_full_name>Shan May Yong</investigator_full_name>
    <investigator_title>Manager</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04483024
org study id: BEC-CH-001
nct id: NCT04483024
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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
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.
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
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: Change in WOMAC scores from baseline
time frame: 6 months
description: knee joint pain
measure: Change in Visual Analgoue Scale (VAS) pain scores from baseline
time frame: 14 days
description: knee joint pain
measure: Change in Bone mass from baseline
time frame: 6 months
description: Lumbar spine, left and right hip
measure: Change in Handgrip strength from baseline
time frame: 6 months
description: Average of both hands
arm group label: Placebo
arm group type: Placebo Comparator
description: Maltodextrin
arm group label: Glucosamine
arm group type: Active Comparator
description: Glucosamine hydrochloride
arm group label: Collagen hydrolysate
arm group type: Experimental
description: 2g of hydrolyzed collagen II
arm group label: Collagen hydrolysate + chicken extract
arm group type: Experimental
description: 2g of hydrolyzed collagen II with chicken extract
intervention type: Dietary Supplement
intervention name: Collagen hydrolysate and chicken extract
description: One bottle (68mL) of collagen hydrolysate (2g) in chicken extract taken daily in the morning after meal for 24 weeks
arm group label: Collagen hydrolysate
arm group label: Collagen hydrolysate + chicken extract
arm group label: Glucosamine
arm group label: Placebo
other name: BRAND'S chicken extract
criteria: 
gender: All
minimum age: 45 Years
maximum age: 75 Years
healthy volunteers: No
last name: Hsin-Nung Shih, MD
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
facility: 
country: Taiwan
responsible party type: Sponsor-Investigator
investigator affiliation: Cerebos Pacific Limited
investigator full name: Shan May Yong
investigator title: Manager
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee