An interventional study of Gold Factor (Gold Nanoparticles, AuNPs) and Placebo in Knee Arthritis, Knee Osteoarthritis and Knee Pain Chronic, sponsored by 4Life Research, LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 87 Years. Per ClinicalTrials.gov, last updated 2022-07-12.
Sponsored by 4Life Research, LLC · Not applicable, Interventional, and Treatment
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.
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.
3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.
This study's enrollment of 51 is below the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.
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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.
Dietary Supplement: Gold Factor (Gold Nanoparticles, AuNPs) · Dietary Supplement: Placebo
Phase 2 (4 weeks): Both groups underwent a month-long "wash out" period, during which they did not ingest any of the Supplement or Placebo. This lasted from weeks 9-12. This phase was not double-blinded as all participants and the researchers were aware of the wash-out procedure.
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.
Dietary Supplement: Gold 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.
Also known as: AuNP Supplement
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.
Knee injury and Osteoarthritis Outcome Score (KOOS): Pain score
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.
Time frame: 20 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS): Symptoms score
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.
Time frame: 20 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS): Function in Activities of Daily Living (ADL) score
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.
Time frame: 20 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS): Function in Sports and Recreation score
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.
Time frame: 20 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS): Quality of Life score
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.
Time frame: 20 weeks
C-Reactive Protein
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.
Time frame: 20 weeks
Range of Motion Bilateral Flexion score
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.
Time frame: 20 weeks
Leg Press repetition number
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.
Time frame: 20 weeks
6-minute Walk distance (meter)
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.
Time frame: 20 weeks
Sit-to Stand repetition number
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.
Time frame: 20 weeks
Single Leg Squats repetition number
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.
Time frame: 20 weeks
Number of Event for Loss of Balance (LOB)
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
Time frame: 20 weeks
Movement efficiency index
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
Time frame: 20 weeks
Squat Lumbar Flexion Deviation score
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
Time frame: 20 weeks
Squat Lateral Shift Deviation score
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
Time frame: 20 weeks
single leg squat speed
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
Time frame: 20 weeks
single leg squat tibial inclination
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
Time frame: 20 weeks
Percentage of participants that would continue taking the product after the study ended.
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.
Time frame: 20 weeks
Plan to share: No
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