Effects of Collagen Peptide Supplementation on Connective Tissue Remodeling, Functional Outcomes, and Wound Healing After Total Knee Arthroplasty (TKA)

NCT05823727 | Not Yet Recruiting DMC

• 1 other identifier: 275656
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

Recruiting will be performed via checking the calendar for scheduled TKA procedures in the \> 8 weeks by clinical staff in the UAMS orthopedic clinic. Clinic staff will look for basic inclusion/exclusion criteria in the EMR for those patients. Clinic staff will either contact directly or send contact information to the PI of this study to contact for recruitment purposes. During the initial phone call, study staff will review inclusion/exclusion criteria to verify eligibility and will discuss study specifics and send a link to the current informed consent form located on the UAMS REDCap server. If the subject wishes to enroll, they will do so via electronic consent through REDCap. REDCap will notify study staff that the consent was signed, then study staff will schedule initial baseline study visit. Visit 1 and Visit 2 will take place at the RIOA at week 0 and week 24, respectively. Participants will report having fasted overnight, and having abstained from alcohol for 24 hours, vigorous exercise for 24 hours, and caffeine for 12 hours. A blood sample will be drawn upon arrival, followed by a DXA scan to measured bone mineral density (BMD) in both hips and lumbar spine, and for body composition, using CTRAL equipment. Participants will also undergo a body water assessment using BIA to determine deuterium dose. Bilateral handgrip strength will be measured via Dynamometer. Participants will fill out a 3-Day food log, physical activity questionnaire, pain scale, KOOS, VR-12, and the POMS. Participants will be given an 8-week supply of their respective treatment supplement, with instructions and a compliance log (to be filled out monthly). Participants will also be given their dose of deuterium oxide (D2O) to be ingested according to instruction at week 2\&3, prior to TKA (week 4). Tissue samples for ACL, bone fragments, and synovial fluid will be collected by the PI during TKA surgery. All other assessments will be taken during clinical visits with the participant's physical therapists and their orthopedic doctors. The PI will attend some of these visits to assess wound healing, administer handgrip strength assessment, and to replenish participant treatment supply.

Conditions

Knee Osteoarthritis

Keywords

collagen peptides, TKA, osteoarthritis, connective tissue

Outcome Measures

Primary Outcomes (1)

• Effects of pre-surgical supplementation on mRNA transcription

  Measuring mRNA in the anterior cruciate ligament extracted during surgery

  2 months after supplementation

Study Arms (2)

Collagen Peptides

EXPERIMENTAL

10 grams per day for 24 weeks

Dietary Supplement: SOLUGEL

Placebo

PLACEBO COMPARATOR

10 grams per day maltodextrin for 24 weeks

Dietary Supplement: Placebo

Interventions

SOLUGEL DIETARY_SUPPLEMENT

Bovine collagen peptide supplement

Also known as: CP

Collagen Peptides

Placebo DIETARY_SUPPLEMENT

Maltodextrin

Placebo

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and Females, 50 to 75 years old
• With a body mass index of 20.0 to 39.9 kg/m2
• Diagnosed with primary osteoarthritis
• Scheduled for a TKA at UAMS (two months prior to surgery) at UAMS
• Live near Little Rock and scheduled to attend physical therapy in Little Rock
• COVID-19 negative and/or asymptomatic.

You may not qualify if:

• Previously sustained serious knee injury or surgery to ACL in TKA knee
• Females not postmenopausal
• Having undergone hormone replacement therapy in the last 12 months.
• Active diagnosis of blood borne infectious disease

Sponsors & Collaborators

• University of Arkansas: lead
• Tessenderlo Group: collaborator

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Shiloah Kviatkovsky

CONTACT

619-677-0792; SKviatkovsky@uams.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Placebo controlled clinical trial.

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: April 21, 2023
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share