NCT06246383

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

February 7, 2024

Status Verified

January 1, 2024

Enrollment Period

3 months

First QC Date

January 22, 2024

Last Update Submit

January 30, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Joint pain

    WOMAC

    8 weeks

Secondary Outcomes (1)

  • mood, sleep, daytime activity, pain perceptions, daytime fatigue, anxiety, perceived stress, pain perceptions, health-related quality of life.

    8 weeks

Study Arms (2)

QActin

ACTIVE COMPARATOR

Cucumber extract

Dietary Supplement: Q Actin

placebo

PLACEBO COMPARATOR

Placebo capsule

Dietary Supplement: Q Actin

Interventions

Q ActinDIETARY_SUPPLEMENT

cucumber extract

QActinplacebo

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.
  • 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.
  • 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.
  • 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).
  • No psychiatric disorder or other condition that might interfere with self-assessment ability.
  • Willingness to follow all study procedures including randomization to one of two groups, and to stay weight stable during the study.
  • Able to walk for at least 6 min at a moderate-to brisk pace.
  • No history of allergic reactions to shellfish products or products containing aspirin.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hausenblas HA, Hooper D, Hooper S. Effectiveness of Cucumis sativus L. Supplementation on Mood, Anxiety, and Sleep Quality: A Randomized Double-Blind Placebo-Controlled Study. Health Sci Rep. 2025 Jul 9;8(7):e70979. doi: 10.1002/hsr2.70979. eCollection 2025 Jul.

MeSH Terms

Conditions

Arthralgia

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2024

First Posted

February 7, 2024

Study Start

February 1, 2024

Primary Completion

May 1, 2024

Study Completion

July 1, 2024

Last Updated

February 7, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

Only group data will be shared

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Summer 2024
Access Criteria
written request