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

NCT04955353 | Completed

• 1 other identifier: BCS 17-033
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Joint Discomfort

Outcome Measures

Primary Outcomes (6)

• Western Ontario and McMaster Universities Arthritis Index (WOMAC) - Baseline

  The WOMAC survey is used to assess joint-related discomfort at baseline. Our version of WOMAC score (adding up from all domains) can range from 0 (min) to 108 (max). The lower the number, the better the outcome (less joint-related discomfort).

  Baseline

• Western Ontario and McMaster Universities Arthritis Index (WOMAC) - Midpoint (Week 4)

  The WOMAC survey is used to assess joint-related discomfort at midpoint of the study. Our version of WOMAC score (adding up from all domains) can range from 0 (min) to 108 (max). The lower the number, the better the outcome (less joint-related discomfort).

  Week 4

• Western Ontario and McMaster Universities Arthritis Index (WOMAC) - Endpoint (Week 8)

  The WOMAC survey is used to assess joint-related discomfort at endpoint of the study. Our version of WOMAC score (adding up from all domains) can range from 0 (min) to 108 (max). The lower the number, the better the outcome (less joint-related discomfort).

  Week 8

• The Visual Analog Scale (VAS) - Baseline

  VAS is used for pain assessment at baseline. VAS ranges from 0 (min) to 10 (max). In our study, only those with VAS of 4 points or more at baseline were included, so our VAS ranges from 4 to 10, with the lower values indicating less pain, and thus better outcome.

  Baseline

• The Visual Analog Scale (VAS) - Midpoint (Week 4)

  VAS is used for pain assessment at midpoint. VAS ranges from 0 (min) to 10 (max). In our study, only those with VAS of 4 points or more at baseline were included, so our VAS ranges from 4 to 10, with the lower values indicating less pain, and thus better outcome.

  Week 4

• The Visual Analog Scale (VAS) - Endpoint (Week 8)

  VAS is used for pain assessment at endpoint. VAS ranges from 0 (min) to 10 (max). In our study, only those with VAS of 4 points or more at baseline were included, so our VAS ranges from 4 to 10, with the lower values indicating less pain, and thus better outcome.

  Week 8

Study Arms (2)

AVC-H2

EXPERIMENTAL

Participants received Avicenna Hydrolyzed Chicken Collagen Type II (AVC-H2), 2.5g daily, for 8 weeks.

Dietary Supplement: AVC-H2

Placebo

PLACEBO COMPARATOR

Participants received placebo of matching amount to that of AVC-H2 daily for 8 weeks.

Dietary Supplement: Placebo

Interventions

AVC-H2 DIETARY_SUPPLEMENT

A total of 2.5g AVC-H2 daily (2 tablets in the morning and 2 in the evening)

AVC-H2

Placebo DIETARY_SUPPLEMENT

A total of 2.5g placebo daily (2 tablets in the morning and 2 in the evening)

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Avicenna Nutraceutical: lead
• BioScreen Testing Services: collaborator

Study Sites (1)

Avicenna Nutraceutical

Atlanta, Georgia, 30005, United States

Location

Study Officials

• Rania Ibrahim, PhD

  BioScreen Testing Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: July 8, 2021
• Study Start: October 16, 2017
• Primary Completion: February 12, 2018
• Study Completion: February 12, 2018
• Last Updated: July 8, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)