Knee OsteoarthritisNCT05823727
Effects of Collagen Peptide Supplementation on Connective Tissue Remodeling, Functional Outcomes, and Wound Healing After Total Knee Arthroplasty (TKA)
A study testing SOLUGEL in people with Knee Osteoarthritis, run by University of Arkansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- SOLUGEL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72201
Shiloah Kviatkovsky, PhD, 619-677-0792, skviatkovsky@uams.edu
About this study
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.
Read the detailed description
UAMS Orthopedic Clinic personnel will monitor the clinic logs for prospective participants meeting the inclusion/exclusion criteria of the study, notifying the study Principal Investigator (PI) of potential study participants. The PI will meet with the with interested participant to obtain consent virtually (via REDCap) prior to scheduling baseline visit (week 0) at the UAMS Reynolds Institute on Aging (RIOA). The potential study participant will be allowed as much time as needed to be comfortable in their decision to participate in the study.
For tissue specimen collection during TKA, the PI will attend the surgery, collecting samples of the ACL, synovial fluid and bone fragments as they are removed (and would otherwise be discarded) by the surgeon. Blood will also be collected by the anesthesiologist after line placement in the operating room. Tissue samples will be prepared as described in the Specimen Handling and Storage Section and taken to the PI's laboratory, the Center for Translational Research in Aging and Longevity (CTRAL) located on the 7th floor of the UAMS RIOA (a secured access floor).
Study Visits Week 0 (Baseline)
- Informed Consent (executed electronically)
- Randomization (Excel Randomization Function)
- Baseline assessments (CTRAL) Knee Injury and Osteoarthritis Outcome Score (KOOS) Veterans RAND 12 (VR-12) Profile of Mood States (POMS) Physical Activity Pain Dietary Intake (3-Day Food Log) Dual-energy X-ray absorptiometry (DXA) scan - bone density (both hips and lumbar spine) Dual-energy X-ray absorptiometry (DXA) scan - body composition Bioelectrical impedance analysis (BIA) Scan - body water Hand grip strength Collecting blood sample (4 mL x 1 for serum and 4 mL x 1 for plasma)
- Treatment 10 g Collagen Peptides or Placebo, Weeks 0 - 24 Deuterated water (D2O), Weeks 6 - 8 Week 4
- Virtual
- Knee Injury and Osteoarthritis Outcome Score (KOOS)
- Veterans RAND 12 (VR-12)
- Profile of Mood States (POMS)
- Physical Activity
- Pain 3-day food log Compliance Week 8
- Virtual
- Knee Injury and Osteoarthritis Outcome Score (KOOS)
- Veterans RAND 12 (VR-12)
- Profile of Mood States (POMS)
- Physical Activity
- Pain 3-day food log Compliance
- Total Knee Arthroplasty Collect Anterior Cruciate Ligament Collect Synovial Fluid Collect blood sample (4 mL x 1 for serum and 4 mL x 1 for plasma)
- Physical Therapy (three times weekly, Weeks 8 - 24) Pain Range of Motion (ROM) for flexion and extension of surgery knee KOOS Jr. Week 10
- Physician Visit Wound healing Pain ROM for flexion and extension of surgery knee Grip Strength Week 12
- Virtual
- Knee Injury and Osteoarthritis Outcome Score (KOOS)
- Veterans RAND 12 (VR-12)
- Profile of Mood States (POMS)
- Physical Activity
- Pain 3-day food log Compliance Week 14
- Physician Visit Wound healing Pain ROM for flexion and extension of surgery knee Grip Strength Week 16
- Virtual
- Knee Injury and Osteoarthritis Outcome Score (KOOS)
- Veterans RAND 12 (VR-12)
- Profile of Mood States (POMS)
- Physical Activity
- Pain 3-day food log Compliance
- Physical Therapy Follow Up Pain ROM KOOS Jr. Functional Measures Battery Week 20
- Virtual
- Knee Injury and Osteoarthritis Outcome Score (KOOS)
- Veterans RAND 12 (VR-12)
- Profile of Mood States (POMS)
- Physical Activity
- Pain 3-day food log Compliance
- Physician Visit Wound healing Pain ROM for flexion and extension of surgery knee Grip Strength Week 24 (Final Assessments - Stop Treatment)
- CTRAL Knee Injury and Osteoarthritis Outcome Score (KOOS) Veterans RAND 12 (VR-12) Profile of Mood States (POMS) Pain Activity DXA - bone mineral density (both hips and lumbar spine) DXA - body composition Grip Strength Compliance 3-Day Food Log
- Conditions
- Knee Osteoarthritis
- Being tested
- SOLUGEL, Placebo
- Keywords
- collagen peptides, TKA, osteoarthritis, connective tissue
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOLUGELDietary supplement
Also called CP
Bovine collagen peptide supplement
PlaceboDietary supplement
Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Collagen Peptides | Experimental | 10 grams per day for 24 weeks Receives: Dietary Supplement: SOLUGEL |
| Placebo | Placebo comparator | 10 grams per day maltodextrin for 24 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of pre-surgical supplementation on mRNA transcription
Measuring mRNA in the anterior cruciate ligament extracted during surgery
Measured: 2 months after supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start1 May 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo controlled clinical trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- Tessenderlo Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823727
- Sponsor's protocol ID
- 275656
- Status last verified
- Jan 2026
- First submitted
- 10 Apr 2023
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Collagen Peptide Supplementation on Connective Tissue Remodeling, Functional Outcomes, and Wound Healing After Total Knee Arthroplasty (TKA)
- ClinicalTrials.gov ID
- NCT05823727
- Acronym / sponsor ID
- 275656
- Conditions
- Knee Osteoarthritis
- Keywords
- collagen peptides, TKA, osteoarthritis, connective tissue
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- Tessenderlo Group
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
UAMS Orthopedic Clinic personnel will monitor the clinic logs for prospective participants meeting the inclusion/exclusion criteria of the study, notifying the study Principal Investigator (PI) of potential study participants. The PI will meet with the with interested participant to obtain consent virtually (via REDCap) prior to scheduling baseline visit (week 0) at the UAMS Reynolds Institute on Aging (RIOA). The potential study participant will be allowed as much time as needed to be comfortable in their decision to participate in the study.
For tissue specimen collection during TKA, the PI will attend the surgery, collecting samples of the ACL, synovial fluid and bone fragments as they are removed (and would otherwise be discarded) by the surgeon. Blood will also be collected by the anesthesiologist after line placement in the operating room. Tissue samples will be prepared as described in the Specimen Handling and Storage Section and taken to the PI's laboratory, the Center for Translational Research in Aging and Longevity (CTRAL) located on the 7th floor of the UAMS RIOA (a secured access floor).
Study Visits Week 0 (Baseline)
- Informed Consent (executed electronically)
- Randomization (Excel Randomization Function)
- Baseline assessments (CTRAL) Knee Injury and Osteoarthritis Outcome Score (KOOS) Veterans RAND 12 (VR-12) Profile of Mood States (POMS) Physical Activity Pain Dietary Intake (3-Day Food Log) Dual-energy X-ray absorptiometry (DXA) scan - bone density (both hips and lumbar spine) Dual-energy X-ray absorptiometry (DXA) scan - body composition Bioelectrical impedance analysis (BIA) Scan - body water Hand grip strength Collecting blood sample (4 mL x 1 for serum and 4 mL x 1 for plasma)
- Treatment 10 g Collagen Peptides or Placebo, Weeks 0 - 24 Deuterated water (D2O), Weeks 6 - 8 Week 4
- Virtual
- Knee Injury and Osteoarthritis Outcome Score (KOOS)
- Veterans RAND 12 (VR-12)
- Profile of Mood States (POMS)
- Physical Activity
- Pain 3-day food log Compliance Week 8
- Virtual
- Knee Injury and Osteoarthritis Outcome Score (KOOS)
- Veterans RAND 12 (VR-12)
- Profile of Mood States (POMS)
- Physical Activity
- Pain 3-day food log Compliance
- Total Knee Arthroplasty Collect Anterior Cruciate Ligament Collect Synovial Fluid Collect blood sample (4 mL x 1 for serum and 4 mL x 1 for plasma)
- Physical Therapy (three times weekly, Weeks 8 - 24) Pain Range of Motion (ROM) for flexion and extension of surgery knee KOOS Jr. Week 10
- Physician Visit Wound healing Pain ROM for flexion and extension of surgery knee Grip Strength Week 12
- Virtual
- Knee Injury and Osteoarthritis Outcome Score (KOOS)
- Veterans RAND 12 (VR-12)
- Profile of Mood States (POMS)
- Physical Activity
- Pain 3-day food log Compliance Week 14
- Physician Visit Wound healing Pain ROM for flexion and extension of surgery knee Grip Strength Week 16
- Virtual
- Knee Injury and Osteoarthritis Outcome Score (KOOS)
- Veterans RAND 12 (VR-12)
- Profile of Mood States (POMS)
- Physical Activity
- Pain 3-day food log Compliance
- Physical Therapy Follow Up Pain ROM KOOS Jr. Functional Measures Battery Week 20
- Virtual
- Knee Injury and Osteoarthritis Outcome Score (KOOS)
- Veterans RAND 12 (VR-12)
- Profile of Mood States (POMS)
- Physical Activity
- Pain 3-day food log Compliance
- Physician Visit Wound healing Pain ROM for flexion and extension of surgery knee Grip Strength Week 24 (Final Assessments - Stop Treatment)
- CTRAL Knee Injury and Osteoarthritis Outcome Score (KOOS) Veterans RAND 12 (VR-12) Profile of Mood States (POMS) Pain Activity DXA - bone mineral density (both hips and lumbar spine) DXA - body composition Grip Strength Compliance 3-Day Food Log
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Placebo controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Collagen Peptides | Experimental | Dietary Supplement: SOLUGEL10 grams per day for 24 weeks |
| Placebo | Placebo comparator | Dietary Supplement: Placebo10 grams per day maltodextrin for 24 weeks |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOLUGELAlso: CPBovine collagen peptide supplement | Dietary supplement | Collagen Peptides |
| PlaceboMaltodextrin | Dietary supplement | Placebo |
Primary outcome
Effects of pre-surgical supplementation on mRNA transcription
Time frame: 2 months after supplementation
Measuring mRNA in the anterior cruciate ligament extracted during surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOLUGEL in people with Knee Osteoarthritis, run by University of Arkansas at 1 site in United States.
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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 27 May 2026. 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 United States. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shiloah Kviatkovsky (619-677-0792, SKviatkovsky@uams.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of pre-surgical supplementation on mRNA transcription (time frame: 2 months after supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 May 2026.