Gold Factor on Knee Joint Health and Function

4Life Research

Status: Completed

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

Treatments: Dietary Supplement: Gold Factor (Gold Nanoparticles, AuNPs); Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05347602

GF-AuKHC46

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 87 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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51 participants in 3 patient groups

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

Other group

Description:

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.

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Gold Factor (Gold Nanoparticles, AuNPs)

Washout Phase

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Dietary Supplement: Gold Factor (Gold Nanoparticles, AuNPs)