Gold Factor on Knee Joint Health and Function

Rheumatoid Arthritis Clinical Trial

Official title:

A Clinical Study to Evaluate the Safety and Efficacy of Microscopic Doses Oral Administration of Gold Nanoparticles (AuNPs) on Knee Joint Health and Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05347602
• Other study ID #: GF-AuKHC46
• Status: Completed
• Phase: N/A
• Start date: August 3, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: July 2022
• Source: 4Life Research, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 87 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Knee Arthritis
• Knee Discomfort
• Knee Osteoarthritis
• Knee Pain Chronic
• Knee Pain Swelling
• Osteoarthritis
• Osteoarthritis, Knee
• Rheumatoid Arthritis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Professional Athletic Orthopedics	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
4Life Research, LLC	Professional Athletic Orthopedics, St. Louis University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	20 weeks
Primary	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.	20 weeks
Primary	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.	20 weeks
Primary	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.	20 weeks
Primary	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.	20 weeks
Primary	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.	20 weeks
Primary	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.	20 weeks
Primary	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.	20 weeks
Primary	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.	20 weeks
Primary	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.	20 weeks
Primary	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.	20 weeks
Secondary	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	20 weeks
Secondary	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	20 weeks
Secondary	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	20 weeks
Secondary	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	20 weeks
Secondary	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	20 weeks
Secondary	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	20 weeks
Secondary	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.	20 weeks