Clinical trial NCT05347602: Gold Factor on Knee Joint Health and Function
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: 4Life Research, LLC
Sponsor class: INDUSTRY
Collaborators: name: Professional Athletic Orthopedics
name: St. Louis University
First posted: 2022-04-26
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 87
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score (KOOS): Pain score
timeFrame: 20 weeks
measure: Knee injury and Osteoarthritis Outcome Score (KOOS): Symptoms score
timeFrame: 20 weeks
measure: Knee injury and Osteoarthritis Outcome Score (KOOS): Function in Activities of Daily Living (ADL) score
timeFrame: 20 weeks
measure: Knee injury and Osteoarthritis Outcome Score (KOOS): Function in Sports and Recreation score
timeFrame: 20 weeks
measure: Knee injury and Osteoarthritis Outcome Score (KOOS): Quality of Life score
timeFrame: 20 weeks
measure: C-Reactive Protein
timeFrame: 20 weeks
measure: Range of Motion Bilateral Flexion score
timeFrame: 20 weeks
measure: Leg Press repetition number
timeFrame: 20 weeks
measure: 6-minute Walk distance (meter)
timeFrame: 20 weeks
measure: Sit-to Stand repetition number
timeFrame: 20 weeks
measure: Single Leg Squats repetition number
timeFrame: 20 weeks
Secondary outcomes:
measure: Number of Event for Loss of Balance (LOB)
timeFrame: 20 weeks
measure: Movement efficiency index
timeFrame: 20 weeks
measure: Squat Lumbar Flexion Deviation score
timeFrame: 20 weeks
measure: Squat Lateral Shift Deviation score
timeFrame: 20 weeks
measure: single leg squat speed
timeFrame: 20 weeks
measure: single leg squat tibial inclination
timeFrame: 20 weeks
measure: Percentage of participants that would continue taking the product after the study ended.
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Professional Athletic Orthopedics
state: Missouri
Study officials:
affiliation: Professional Athletic Orthopedics
name: Richard C Lehman, MD
role: PRINCIPAL_INVESTIGATOR
References: