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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Joint Pain
• Intervention / Treatment: Dietary supplement: Q Actin

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)

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Inclusion and Exclusion Criteria: Participants (N = 80) will meet the inclusion criteria if they: are healthy adults (age range between 35 to 70 years), chose to sign Sterling IRB approved consent forms, and willing to forego use of all supplement products with claims regarding joint health during the study period. Our goal is to have 80 participants complete the intervention. To control for potential dropout we will recruit 90 participants for this trial.

Other inclusion and exclusion criteria for this study included:

1. Self-reported history (>3 months) of joint pain in the knees, hip, ankles, shoulders, or hands. Minimum symptom severity was ensured by using a WOMAC pain index score of at least 2 points.
2. No history of regular NSAID use (e.g., ibuprofen, aspirin) during the previous two weeks, and willingness to avoid NSAIDs use during the 8-week study.
3. Not on other medications (e.g., analgesic gels, arthritis medications, other anti-inflammatory drugs) or supplements (in particular, glucosamine and chondroitin) for joint pain for the previous two weeks, and willing to avoid use of these during the 8-week study.
4. No serious medical problems (current cancer case, severe rheumatoid arthritis, recent heart attack, recent stroke, congestive heart failure, ulcers, kidney disease, or other disease that would interfere with study participation).
5. No psychiatric disorder or other condition that might interfere with self-assessment ability.
6. Willingness to follow all study procedures including randomization to one of two groups, and to stay weight stable during the study.
7. Able to walk for at least 6 min at a moderate-to brisk pace.
8. No history of allergic reactions to shellfish products or products containing aspirin.

9. Pregnant or trying to conceive. Note: Paracetamol (i.e., acetaminophen as found in Tylenol) will be allowed as a rescue medicine for pain during the study as needed, with usage recorded.

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   Exclusion Criteria:

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: QActin; Cucumber extract	Dietary supplement: Q Actin; cucumber extract
Placebo Comparator: placebo; Placebo capsule	Dietary supplement: Q Actin; cucumber extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Joint pain	WOMAC	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mood, sleep, daytime activity, pain perceptions, daytime fatigue, anxiety, perceived stress, pain perceptions, health-related quality of life.	POMS, PSQI, Oura Ring, Daytime Fatigue Scale, Perceived Stress Scale, Trait Anxiety Scale, Pain Severity Scale, Health-related Quality of Life Scale	8 weeks

Collaborators and Investigators

• Sponsor: Jacksonville University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Estimated): February 7, 2024

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia
• Other Study ID Numbers: JacksonvilleU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Only group data will be shared
• IPD Sharing Time Frame: Summer 2024
• IPD Sharing Access Criteria: written request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No