Knee Arthritis, Knee Discomfort, Knee Osteoarthritis, Knee Pain Chronic, Knee Pain Swelling, Rheumatoid Arthritis
Conditions
Keywords
Knee joint health, Arthritis, Gold nanoparticles (AuNPs), Knee joint function, Osteoarthritis, Rheumatoid Arthritis
Brief summary
The purpose of this clinical study was to determine whether gold nanoparticles (AuNP) supplement holds clinical value in improving joint health, function, and quality of life for arthritis patients.
Detailed description
The purpose of this clinical study was to determine whether gold nanoparticles (AuNP) supplement holds clinical value in improving knee joint health, function, and quality of life for arthritis patients. A total of 51 participants were followed for 20 weeks through a three phase longitudinal study. Both subjective and objective parameters were used to measure and monitor changes in knee joint health and function, as well as quality of life.
Interventions
DIETARY_SUPPLEMENTGold Factor (Gold Nanoparticles, AuNPs)
AuNP used in the study is an aqueous suspension of clean-surfaced, faceted gold nanoparticles that have extraordinary catalytic capabilities. AuNP were 8 - 28 nm in diameter, with varying shapes from bipyramids to polyhedrons. To avoid contamination, AuNP was suspended in ultra-pure water, and were not coated with any proteins or molecules to avoid negative reactions within living tissues. This resulted in a rose-pink color due to the incident light inducing a specific resonance known as the localized surface plasmon resonance. The AuNP supplement used in this study contains elemental gold at 6 ppm. Study dosage is 1 oz per day, which is about 0.17 mg elemental gold per day.
DIETARY_SUPPLEMENTPlacebo
For the Placebo, water and red dye were mixed to create a placebo liquid with the same rose-pink shade as the AuNP supplement, along with flavoring that matched the AuNP supplement.
Sponsors
Professional Athletic Orthopedics
St. Louis University
4Life Research, LLC
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Phase 1 was double-blinded, neither investigator nor participants know what products each participant was taking.
Intervention model description
Fifty-one (51) subjects were determined eligible for the study after the screenings and then were divided into two groups, AuNP Supplement (n=26) and Placebo (n=25). The study was partially double-blinded, and divided into three phases as follows: Phase 1: Supplement and Placebo groups ingested Supplement and Placebo as instructed. This phase was double-blinded. Phase 2: Both groups underwent a month-long wash out period, during which they did not ingest any of the Supplement or Placebo. This phase was not double-blinded as all participants and the researchers were aware of the wash-out procedure. Phase 3: Both groups took the Supplement as instructed. This phase was open labeled, as all participants and the researchers were aware that all participants were ingesting the Supplement.
Eligibility
Sex/Gender
ALL
Age
18 Years to 87 Years
Healthy volunteers
No
Inclusion criteria
* ≥ 18 and \<87 years of age * Having arthritis * Suffering from chronic knee pain * Failed treatments to date - including surgery, Physical Therapy, NSAIDs * Must agree to maintain the same eating, exercise, and sleep arrangements for the whole duration of the study
Exclusion criteria
* Having bacterial, intra-articular, or knee infections * Had any knee related partial or complete total knee replacement within 3 months prior to the start of the study * Had recent (3 months prior to start of the study) knee injection * Currently on NSAIDs * currently pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Single Leg Squats repetition number | 20 weeks | All participants completed a physical assessment conducted by an assigned physical therapist: Range of Motion Bilateral Flexion, Leg Press, Walk Test, Sit-to Stand and Single Leg Squats. |
| Knee injury and Osteoarthritis Outcome Score (KOOS): Function in Sports and Recreation score | 20 weeks | The KOOS survey was chosen due to its repeatability, and it gave scores of 0-100 for four separate categories: Symptoms, Pain, Function & Daily Living, Sports & Recreational Activities, and Quality of Life. Under KOOS scoring guidelines, a score of zero represents extreme knee problems, and 100 represents complete function of the knee with no pain, discomfort, or other joint related problems. |
| Knee injury and Osteoarthritis Outcome Score (KOOS): Quality of Life score | 20 weeks | The KOOS survey was chosen due to its repeatability, and it gave scores of 0-100 for four separate categories: Symptoms, Pain, Function & Daily Living, Sports & Recreational Activities, and Quality of Life. Under KOOS scoring guidelines, a score of zero represents extreme knee problems, and 100 represents complete function of the knee with no pain, discomfort, or other joint related problems. |
| C-Reactive Protein | 20 weeks | C-Reactive Protein levels were measured at T0 for baseline scores, and then measured again at T1, T2, and T3. As CRP levels are biomarkers of systemic inflammation, it was expected to see a decrease in CRP levels when taking AuNP Supplement. |
| Range of Motion Bilateral Flexion score | 20 weeks | All participants completed a physical assessment conducted by an assigned physical therapist: Range of Motion Bilateral Flexion, Leg Press, Walk Test, Sit-to Stand and Single Leg Squats. |
| Leg Press repetition number | 20 weeks | All participants completed a physical assessment conducted by an assigned physical therapist: Range of Motion Bilateral Flexion, Leg Press, Walk Test, Sit-to Stand and Single Leg Squats. |
| 6-minute Walk distance (meter) | 20 weeks | All participants completed a physical assessment conducted by an assigned physical therapist: Range of Motion Bilateral Flexion, Leg Press, Walk Test, Sit-to Stand and Single Leg Squats. |
| Sit-to Stand repetition number | 20 weeks | All participants completed a physical assessment conducted by an assigned physical therapist: Range of Motion Bilateral Flexion, Leg Press, Walk Test, Sit-to Stand and Single Leg Squats. |
| Knee injury and Osteoarthritis Outcome Score (KOOS): Pain score | 20 weeks | The KOOS survey was chosen due to its repeatability, and it gave scores of 0-100 for four separate categories: Symptoms, Pain, Function & Daily Living, Sports & Recreational Activities, and Quality of Life. Under KOOS scoring guidelines, a score of zero represents extreme knee problems, and 100 represents complete function of the knee with no pain, discomfort, or other joint related problems. |
| Knee injury and Osteoarthritis Outcome Score (KOOS): Symptoms score | 20 weeks | The KOOS survey was chosen due to its repeatability, and it gave scores of 0-100 for four separate categories: Symptoms, Pain, Function & Daily Living, Sports & Recreational Activities, and Quality of Life. Under KOOS scoring guidelines, a score of zero represents extreme knee problems, and 100 represents complete function of the knee with no pain, discomfort, or other joint related problems. |
| Knee injury and Osteoarthritis Outcome Score (KOOS): Function in Activities of Daily Living (ADL) score | 20 weeks | The KOOS survey was chosen due to its repeatability, and it gave scores of 0-100 for four separate categories: Symptoms, Pain, Function & Daily Living, Sports & Recreational Activities, and Quality of Life. Under KOOS scoring guidelines, a score of zero represents extreme knee problems, and 100 represents complete function of the knee with no pain, discomfort, or other joint related problems. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Movement efficiency index | 20 weeks | DorsaVi Assessments: Loss of Balance (LOB), Movement efficiency index, Squat Lumbar Flexion Deviation, Squat Lateral Shift Deviations, single leg squat scores, speed, and tibial inclination |
| Squat Lumbar Flexion Deviation score | 20 weeks | DorsaVi Assessments: Loss of Balance (LOB), Movement efficiency index, Squat Lumbar Flexion Deviation, Squat Lateral Shift Deviations, single leg squat scores, speed, and tibial inclination |
| Squat Lateral Shift Deviation score | 20 weeks | DorsaVi Assessments: Loss of Balance (LOB), Movement efficiency index, Squat Lumbar Flexion Deviation, Squat Lateral Shift Deviations, single leg squat scores, speed, and tibial inclination |
| single leg squat speed | 20 weeks | DorsaVi Assessments: Loss of Balance (LOB), Movement efficiency index, Squat Lumbar Flexion Deviation, Squat Lateral Shift Deviations, single leg squat scores, speed, and tibial inclination |
| single leg squat tibial inclination | 20 weeks | DorsaVi Assessments: Loss of Balance (LOB), Movement efficiency index, Squat Lumbar Flexion Deviation, Squat Lateral Shift Deviations, single leg squat scores, speed, and tibial inclination |
| Percentage of participants that would continue taking the product after the study ended. | 20 weeks | Acceptability of AuNP Supplement was analyzed at the end of the study. Participants were asked if they would continue taking the product after the study in their final exit survey. |
| Number of Event for Loss of Balance (LOB) | 20 weeks | DorsaVi Assessments: Loss of Balance (LOB), Movement efficiency index, Squat Lumbar Flexion Deviation, Squat Lateral Shift Deviations, single leg squat scores, speed, and tibial inclination |
Countries
United States
Outcome results
None listed