Knee OsteoarthritisPhase 1NCT04483024
Effects of Chicken Extract and Collagen on Mobility
A Phase 1 study testing Collagen hydrolysate and chicken extract in people with Knee Osteoarthritis and Muscle Loss, run by Shan May Yong at 1 site in Taiwan.
Trial 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 Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Knee Osteoarthritis, Muscle Loss
- What is being tested?
- Collagen hydrolysate and chicken extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2018to 1 Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male/female at 45 - 75 years of age
- Subject has a body mass index range of 18.0 to 30.0 kg/m2, inclusive, and weighs at least 40 kg at screening
- Subject agrees not to participate in another interventional study while participating in the present study, defined as signing the informed consent form until completion of the study.
- Experience knee pain ≥ 3 months
- WOMAC total pain score ≥ 6 evaluated by walking on a flat surface, descending and/or ascending stairs
- Subject has mild-to-moderate knee osteoarthritis (OA) at grade 1 - 3 per Kellgren-Lawrence grading system
- Experience loss in muscular strength or physical performance greater than 1 year
- Be willing to refrain from hormone therapy and dietary supplements such as calcium, vitamin D, supplements enriched with proteins, omega-3, omega-6, glucosamine, or chondroitin during the entire study
Who cannot join
- Inability to participate in the evaluation of the study
- Active viral infection or bacterial infection based on clinical observations
- Subjects with history of rheumatoid arthritis or any other inflammatory arthritis
- Chronic medical conditions including renal dysfunctions, psychiatric disorders, or diabetes (or HbA1c > 6.5%)
- History of stroke or myocardial infarction, mental retardation, or schizophrenia
- Gout
Show all 19Show fewer
- Paget disease of bone or spinal disc herniation
- Subjects intolerant or allergic to protein-based food or supplement
- Anti-osteoporotic therapy in the past year
- Intra-articular injection during previous 3 months (6 months for hyaluronic acid) applied at target knee joint (most painful knee joint at Screening visit)
- Current corticosteroid therapy
- Those expecting knee arthroscopy or arthroplasty
- Life-threatening pathology (such as cancer) in remission for less than 1 year or still ongoing
- Psychological or linguistic incapability to sign the informed consent
- History of allergy to chicken meat
- Pregnant or lactating women
- Suspected or known alcohol abuse or addiction (consume ≥ 14 drinks of alcohol per week; 1 drink: ~355-mL beer or 150-mL wine)
- Subjects with any other conditions or diseases that investigator considers not appropriate to be entered in the study
- Subjects with active pathology that could confound interpretation of knee pain or any conditions that interfere with adherence
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Knee Osteoarthritis, Muscle Loss
- Being tested
- Collagen hydrolysate and chicken extract
- Medical subject headings
- Osteoarthritis, Knee, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen hydrolysate and chicken extractDietary supplement
Also called BRAND'S chicken extract
One bottle (68mL) of collagen hydrolysate (2g) in chicken extract taken daily in the morning after meal for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Maltodextrin Receives: Dietary Supplement: Collagen hydrolysate and chicken extract |
| Glucosamine | Active comparator | Glucosamine hydrochloride Receives: Dietary Supplement: Collagen hydrolysate and chicken extract |
| Collagen hydrolysate | Experimental | 2g of hydrolyzed collagen II Receives: Dietary Supplement: Collagen hydrolysate and chicken extract |
| Collagen hydrolysate + chicken extract | Experimental | 2g of hydrolyzed collagen II with chicken extract Receives: Dietary Supplement: Collagen hydrolysate and chicken extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in WOMAC scores from baseline
knee joint pain
Measured: 6 months
Change in Visual Analgoue Scale (VAS) pain scores from baseline
knee joint pain
Measured: 14 days
Secondary outcomes (2)
Change in Bone mass from baseline
Lumbar spine, left and right hip
Measured: 6 months
Change in Handgrip strength from baseline
Average of both hands
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start1 Dec 2018
- Primary completion31 Oct 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shan May Yong
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chang Gung Memorial Hospital
- Responsible party
- Sponsor-investigator, Shan May Yong, Cerebos Pacific Limited
- Investigators
- Hsin-Nung Shih, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483024
- Sponsor's protocol ID
- BEC-CH-001
- Status last verified
- Jul 2020
- First submitted
- 20 Jul 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen CC, Chang SS, Chang CH, Hu CC, Nakao Y, Yong SM, Mandy YLO, Lim CJ, Shim EK, Shih HN. Randomized, double-blind, four-arm pilot study on the effects of chicken essence and type II collagen hydrolysate on joint, bone, and muscle functions. Nutr J. 2023 Mar 15;22(1):17. doi: 10.1186/s12937-023-00837-w.
PubMed 36918892
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04483024
- Acronym / sponsor ID
- BEC-CH-001
- Conditions
- Knee Osteoarthritis, Muscle Loss
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Shan May YongIndustry (pharma, biotech, devices)
- Collaborators
- Chang Gung Memorial Hospital
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 23 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Collagen hydrolysate and chicken extractMaltodextrin |
| Glucosamine | Active comparator | Dietary Supplement: Collagen hydrolysate and chicken extractGlucosamine hydrochloride |
| Collagen hydrolysate | Experimental | Dietary Supplement: Collagen hydrolysate and chicken extract2g of hydrolyzed collagen II |
| Collagen hydrolysate + chicken extract | Experimental | Dietary Supplement: Collagen hydrolysate and chicken extract2g of hydrolyzed collagen II with chicken extract |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male/female at 45 - 75 years of age
- Subject has a body mass index range of 18.0 to 30.0 kg/m2, inclusive, and weighs at least 40 kg at screening
- Subject agrees not to participate in another interventional study while participating in the present study, defined as signing the informed consent form until completion of the study.
- Experience knee pain ≥ 3 months
- WOMAC total pain score ≥ 6 evaluated by walking on a flat surface, descending and/or ascending stairs
Key exclusion criteria (19 listed)
- Inability to participate in the evaluation of the study
- Active viral infection or bacterial infection based on clinical observations
- Subjects with history of rheumatoid arthritis or any other inflammatory arthritis
- Chronic medical conditions including renal dysfunctions, psychiatric disorders, or diabetes (or HbA1c > 6.5%)
- History of stroke or myocardial infarction, mental retardation, or schizophrenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collagen hydrolysate and chicken extractAlso: BRAND'S chicken extractOne bottle (68mL) of collagen hydrolysate (2g) in chicken extract taken daily in the morning after meal for 24 weeks | Dietary supplement | Collagen hydrolysate, Collagen hydrolysate + chicken extract, Glucosamine, Placebo |
Primary outcome
Change in WOMAC scores from baseline
Time frame: 6 months
knee joint pain
Change in Visual Analgoue Scale (VAS) pain scores from baseline
Time frame: 14 days
knee joint pain
2 secondary outcomes
Change in Bone mass from baseline
Time frame: 6 months
Change in Handgrip strength from baseline
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Derived from this study: PubMed 36918892Chen CC, Chang SS, Chang CH, Hu CC, Nakao Y, Yong SM, Mandy YLO, Lim CJ, Shim EK, Shih HN. Randomized, double-blind, four-arm pilot study on the effects of chicken essence and type II collagen hydrolysate on joint, bone, and muscle functions. Nutr J. 2023 Mar 15;22(1):17. doi: 10.1186/s12937-023-00837-w.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsin-Nung Shih, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Collagen hydrolysate and chicken extract in people with Knee Osteoarthritis and Muscle Loss, run by Shan May Yong at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in WOMAC scores from baseline (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04483024, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.