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UnknownNCT06246383

Effectiveness of Cucumber Extract on Joint Pain

Effectiveness of Standardised Ido-BR1 Cucumber Extract (Q-ActinTM) on Mild to Moderate Joint Pain: A Randomized Double-blind Placebo-Controlled Study

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
80 (estimated)
Sponsor
Jacksonville University · Academic / Other
Sex
All
Age
30 Years – 70 Years
Healthy volunteers
Accepted

Summary

Joint pain is reported by about 1/3 of U.S. adults, and increases with age reaching 50% prevalence among the elderly \[1\]. Joint pain is associated with substantial activity limitation, work disability, sleep disturbance, negative mood (e.g., depression, anxiety, stress), and reduced quality of life (2, 3). Conventional treatment of joint pain with non-steroidal anti-inflammatory drugs (NSAIDs) and other analgesics is associated with gastrointestinal and cardiovascular side effects, and other adverse health effects \[4\]. Use of alternative supplements is reported by about 50% of people with knee osteoarthritis, and well-designed human trials are needed to identify effective analgesic alternatives \[5\]. The most widely used and studied joint pain supplements include those related to chondroprotection such as glucosamine, chondroitin, collagen hydrolysates, and hyaluronic acid \[6-9\]. Further research is needed examining the effects of other herbal supplementation on joint pain and overall health. Preliminary research reveals Q-ActinTM supplementation may be an effective intervention to reduce OA-related pain compared with standard treatments. Q-ActinTM is a cucumber extract with the anti-inflammatory iminosugar idoBR1 standardised to over 1%. Study Purpose To conduct a 8 week randomized double-blind placebo-controlled trial to examine the effectiveness of daily use of Q-ActinTM supplementation compared to placebo on joint pain, stiffness, function, mood, sleep, daytime activity, and health-related quality of life in adults with a history (\>3 months) of mild to moderate joint pain.

Detailed description

To conduct a 8 week randomized double-blind placebo-controlled trial to examine the effectiveness of daily use of Q-ActinTM supplementation compared to placebo on joint pain, stiffness, function, mood, sleep, daytime activity, and health-related quality of life in adults with a history (\>3 months) of mild to moderate joint pain. Assessments will be completed at Day 0 (Baseline), Week 2, Week 4, and Week 8. The primary outcome will be on joint pain, stiffness, and function (as assessed by the WOMAC). Secondary outcomes will be sleep quality, physical activity, daytime fatigue, mood, anxiety, perceived stress, pain severity, tolerance and limitations, and health-related quality of life. Adults (N = 80) will be randomized to one of the following conditions: * Q-ActinTM (n = 40) * Placebo control (n = 40)

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTQ Actincucumber extract

Timeline

Start date
2024-02-01
Primary completion
2024-05-01
Completion
2024-07-01
First posted
2024-02-07
Last updated
2024-02-07

Source: ClinicalTrials.gov record NCT06246383. Inclusion in this directory is not an endorsement.