Efficacy of a Hydrolyzed Chicken Collagen Type II in Alleviating Joint Discomfort

Completed · Not applicable · Has a placebo group

Conditions studied: Joint Discomfort

In brief

Joint pain and disease affect more than one in four adults in the United States. We conducted a double-blind, randomized, placebo-controlled trial to investigate the efficacy of a hydrolyzed chicken collagen type II (HCII) supplement in reducing joint-related discomfort such as pain and stiffness, and in improving mobility. We enrolled adults aged 40-65y (65.5% were women) who had joint discomfort, but had no co-morbidities, and were not taking pain medications. The participants were randomized to receive either the HCII supplement (n=47) or a placebo (n=43) for eight weeks. At baseline, week 4, and week 8, we administered the Western Ontario and McMaster Universities Arthritis Index (WOMAC) survey with three additional wrist-related questions and the Visual Analog Scale for assessments of joint-related symptoms.

Key facts

Study ID

NCT04955353

Run by

Avicenna Nutraceutical

People needed

90

Starts

2017-10-16

Expected to finish

2018-02-12

Last updated by the study team

2021-07-08

Who can join

Age: 40 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• men and women 40-65 years of age
• all races
• good general health (free of any systemic or dermatological disorder) but have joint pain, stiffness, or other joint-related discomfort
• literate and able to understand the informed consent document, as well as able to choose whether or not to sign the form
• able to complete a preliminary medical history, Health Insurance Portability and Accountability Act (HIPAA), and Code of Conduct form
• able to cooperate with the Investigator and research staff
• willing and able to comply with the instructions to use the test product, and to complete the full course of the study
• agree to not participate in any other study during the entire duration of the study
• have not participated in a similar study in the past thirty days
• agree to refrain from using any joint-pain relief products except for the product received from our re-search staff during the entire duration of the study
• agree to take a urine pregnancy test prior to enrollment

You may not qualify if…

• individuals currently taking any medications that may mask or interfere with the test results
• those who had a history of any acute or chronic disease that would interfere with or increase the risk of study participation
• those with a history of diseases of chronic inflammation (e.g., septic arthritis, gout, and rheumatoid arthritis)
• those who had a recent injury in the hip, knee, and/or wrist in the past six months
• those who had a history of hip, knee, and/or wrist surgery
• those who had injections to reduce joint discomfort in the past 12 months
• those who are at high risk of adverse outcomes for participating in the study and thus may invalidate the study due to confounding factors
• pregnancy or lactation
• individuals who had diabetes or hyperuricemia
• body mass index > 30 kg/m2
• history of substance abuse
• known history of hypersensitivity to any cosmetics, personal care products, or fragrances
• known allergy to eggs, chicken, or any other ingredients in the test product
• individuals who have phenylketonuria
• those who need to take calcium supplementation
• those who are affiliated with the clinical trial agency

Where it is running

• Avicenna Nutraceutical — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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