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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Taiwan1 site
  • Linkou Chang Gung Memorial Hospital

    Taipei

Other trials in Taiwan

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.

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 groups in NCT04483024
Study groupRoleWhat they receive
PlaceboPlacebo comparatorMaltodextrin
Receives: Dietary Supplement: Collagen hydrolysate and chicken extract
GlucosamineActive comparatorGlucosamine hydrochloride
Receives: Dietary Supplement: Collagen hydrolysate and chicken extract
Collagen hydrolysateExperimental2g of hydrolyzed collagen II
Receives: Dietary Supplement: Collagen hydrolysate and chicken extract
Collagen hydrolysate + chicken extractExperimental2g 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.

  1. Change in WOMAC scores from baseline

    knee joint pain

    Measured: 6 months

  2. Change in Visual Analgoue Scale (VAS) pain scores from baseline

    knee joint pain

    Measured: 14 days

Secondary outcomes (2)
  1. Change in Bone mass from baseline

    Lumbar spine, left and right hip

    Measured: 6 months

  2. 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.

  1. First posted23 Jul 2020
  2. Study start1 Dec 2018
  3. Primary completion31 Oct 2019
  4. Study completion1 Dec 2019

Resources

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)
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

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.

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