Gold Factor on Knee Joint Health and Function

NCT05347602 | Completed

• 1 other identifier: GF-AuKHC46
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Arthritis; Knee Osteoarthritis; Knee Pain Chronic; Knee Discomfort; Rheumatoid Arthritis; Knee Pain Swelling

Keywords

Knee joint health; Arthritis; Gold nanoparticles (AuNPs); Knee joint function; Osteoarthritis; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (11)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (7)

• Number of Event for Loss of Balance (LOB)

  20 weeks

• Movement efficiency index

  20 weeks

• Squat Lumbar Flexion Deviation score

  20 weeks

• Squat Lateral Shift Deviation score

  20 weeks

• single leg squat speed

  20 weeks

Study Arms (3)

Phase 1: double-blinded placebo-controlled Supplement vs Placebo

OTHER

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

Washout Phase

NO INTERVENTION

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: Supplement

ACTIVE COMPARATOR

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)

Interventions

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.

Also known as: AuNP Supplement

Phase 1: double-blinded placebo-controlled Supplement vs Placebo; Phase 3: 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.

Phase 1: double-blinded placebo-controlled Supplement vs Placebo

Eligibility Criteria

• Age: 18 Years - 87 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• 4Life Research, LLC: lead
• Professional Athletic Orthopedics: collaborator
• St. Louis University: collaborator

Study Sites (1)

Professional Athletic Orthopedics

St Louis, Missouri, 63122, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Arthritis, Rheumatoid; Arthritis; Osteoarthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Richard C Lehman, MD

  Professional Athletic Orthopedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Phase 1 was double-blinded, neither investigator nor participants know what products each participant was taking.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Fifty-one (51) subjects were determined eligible for the study after the screenings and then were divided into two groups, AuNP Supplement (n=26) and Placebo (n=25). The study was partially double-blinded, and divided into three phases as follows: 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.

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 26, 2022
• Study Start: August 3, 2020
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: July 12, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)