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Completed

NCT Number: NCT05347602

Gold Factor on Knee Joint Health and Function

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.

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Key information

Conditions

Knee Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Knee Discomfort Knee Osteoarthritis Knee Pain Chronic Knee Pain Swelling Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases

Age range

18 year–87 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Professional Athletic Orthopedics

St Louis, Missouri, 63122, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gold Factor (Gold Nanoparticles, AuNPs)

Dietary Supplement

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.

Other names: AuNP Supplement

Placebo

Dietary 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.

Primary outcomes

  1. Knee injury and Osteoarthritis Outcome Score (KOOS): Pain score

    Time frame: 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.

  2. Knee injury and Osteoarthritis Outcome Score (KOOS): Symptoms score

    Time frame: 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.

  3. Knee injury and Osteoarthritis Outcome Score (KOOS): Function in Activities of Daily Living (ADL) score

    Time frame: 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.

  4. Knee injury and Osteoarthritis Outcome Score (KOOS): Function in Sports and Recreation score

    Time frame: 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.

  5. Knee injury and Osteoarthritis Outcome Score (KOOS): Quality of Life score

    Time frame: 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.

  6. C-Reactive Protein

    Time frame: 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.

  7. Range of Motion Bilateral Flexion score

    Time frame: 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.

  8. Leg Press repetition number

    Time frame: 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.

  9. 6-minute Walk distance (meter)

    Time frame: 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.

  10. Sit-to Stand repetition number

    Time frame: 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.

  11. Single Leg Squats repetition number

    Time frame: 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 outcomes

  1. Number of Event for Loss of Balance (LOB)

    Time frame: 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

  2. Movement efficiency index

    Time frame: 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

  3. Squat Lumbar Flexion Deviation score

    Time frame: 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

  4. Squat Lateral Shift Deviation score

    Time frame: 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

  5. single leg squat speed

    Time frame: 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

  6. single leg squat tibial inclination

    Time frame: 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

  7. Percentage of participants that would continue taking the product after the study ended.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

4Life Research, LLC

Industry

Collaborators

  • Professional Athletic Orthopedics
  • St. Louis University

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 26, 2022
Registry last updated
Jul 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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