Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
51 participants
INTERVENTIONAL
2020-08-03
2020-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
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.
TREATMENT
DOUBLE
Study Groups
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Phase 1: double-blinded placebo-controlled Supplement vs 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.
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.
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.
Washout Phase
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.
No interventions assigned to this group
Phase 3: Supplement
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
87 Years
ALL
No
Sponsors
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Professional Athletic Orthopedics
UNKNOWN
St. Louis University
OTHER
4Life Research, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Richard C Lehman, MD
Role: PRINCIPAL_INVESTIGATOR
Professional Athletic Orthopedics
Locations
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Professional Athletic Orthopedics
St Louis, Missouri, United States
Countries
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Other Identifiers
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GF-AuKHC46
Identifier Type: -
Identifier Source: org_study_id
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