Trials / Completed
CompletedNCT05347602
Gold Factor on Knee Joint Health and Function
A Clinical Study to Evaluate the Safety and Efficacy of Microscopic Doses Oral Administration of Gold Nanoparticles (AuNPs) on Knee Joint Health and Function
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- 4Life Research, LLC · Industry
- Sex
- All
- Age
- 18 Years – 87 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Knee Arthritis
- Knee Osteoarthritis
- Knee Pain Chronic
- Knee Discomfort
- Rheumatoid Arthritis
- Knee Pain Swelling
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| DIETARY_SUPPLEMENT | Placebo | 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. |
Timeline
- Start date
- 2020-08-03
- Primary completion
- 2020-12-30
- Completion
- 2020-12-30
- First posted
- 2022-04-26
- Last updated
- 2022-07-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05347602. Inclusion in this directory is not an endorsement.