Effects of Chicken Extract and Collagen on Mobility

NCT04483024 | Completed Phase 1

• 1 other identifier: BEC-CH-001
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Knee Osteoarthritis; Muscle Loss

Outcome Measures

Primary Outcomes (2)

• Change in WOMAC scores from baseline

  knee joint pain

  6 months

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

  knee joint pain

  14 days

Secondary Outcomes (2)

• Change in Bone mass from baseline

  6 months

• Change in Handgrip strength from baseline

  6 months

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Maltodextrin

Dietary Supplement: Collagen hydrolysate and chicken extract

Glucosamine

ACTIVE COMPARATOR

Glucosamine hydrochloride

Dietary Supplement: Collagen hydrolysate and chicken extract

Collagen hydrolysate

EXPERIMENTAL

2g of hydrolyzed collagen II

Dietary Supplement: Collagen hydrolysate and chicken extract

Collagen hydrolysate + chicken extract

EXPERIMENTAL

2g of hydrolyzed collagen II with chicken extract

Dietary Supplement: Collagen hydrolysate and chicken extract

Interventions

Collagen hydrolysate and chicken extract DIETARY_SUPPLEMENT

One bottle (68mL) of collagen hydrolysate (2g) in chicken extract taken daily in the morning after meal for 24 weeks

Also known as: BRAND'S chicken extract

Collagen hydrolysate; Collagen hydrolysate + chicken extract; Glucosamine; Placebo

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Shan May Yong: lead
• Chang Gung Memorial Hospital: collaborator

Study Sites (1)

Linkou Chang Gung Memorial Hospital

Taipei, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 36918892 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Muscular Atrophy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Hsin-Nung Shih, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Manager

Model Details: A Randomized, Double-blind, Four-arm Pilot Study to Evaluate the Effects of Brands Chicken Extract and Collagen on Joint, Bone, and Muscle Functions

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 23, 2020
• Study Start: December 1, 2018
• Primary Completion: October 31, 2019
• Study Completion: December 1, 2019
• Last Updated: July 29, 2020

Record last verified: 2020-07

Locations

TW (1)