Gold Factor on Knee Joint Health and Function
- Conditions
- Knee Pain ChronicKnee Pain SwellingKnee ArthritisKnee OsteoarthritisKnee DiscomfortRheumatoid Arthritis
- Interventions
- Dietary Supplement: Gold Factor (Gold Nanoparticles, AuNPs)Dietary Supplement: Placebo
- Registration Number
- NCT05347602
- Lead Sponsor
- 4Life Research, LLC
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
- ≥ 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Phase 3: Supplement Gold Factor (Gold Nanoparticles, AuNPs) Phase 3 (8 weeks): Both groups took the Supplement at 3 oz per day as a loading dose for four weeks (weeks 13 - 16), and then 2 oz per day for the final four weeks (weeks 17 - 20). This phase was open labeled, as all participants and the researchers were aware that all participants were ingesting the Supplement. Phase 1: double-blinded placebo-controlled Supplement vs Placebo Placebo Phase 1 (8 weeks): Supplement and Placebo groups ingested 3 oz of Supplement and Placebo per day respectively for the first four weeks as a loading dose, and then switched to 2 oz per day for weeks 5 - 8. This phase was double-blinded. Phase 1: double-blinded placebo-controlled Supplement vs Placebo Gold Factor (Gold Nanoparticles, AuNPs) Phase 1 (8 weeks): Supplement and Placebo groups ingested 3 oz of Supplement and Placebo per day respectively for the first four weeks as a loading dose, and then switched to 2 oz per day for weeks 5 - 8. This phase was double-blinded.
- Primary Outcome Measures
Name Time Method 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): 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.
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.
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.
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.
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 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.
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.
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.
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.
- Secondary Outcome Measures
Name Time Method 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
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
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.
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
Trial Locations
- Locations (1)
Professional Athletic Orthopedics
🇺🇸Saint Louis, Missouri, United States