Joint PainNCT06246383
Effectiveness of Cucumber Extract on Joint Pain
A study testing Q Actin in people with Joint Pain, run by Jacksonville University.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Joint Pain
- What is being tested?
- Q Actin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
- 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).
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- 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.
- -
Who cannot join
- -
About this study
Official title: 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.
Read more
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.
Read the 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
- Joint Pain
- Being tested
- Q Actin
- Medical subject headings
- Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q ActinDietary supplement
cucumber extract
| Study group | Role | What they receive |
|---|---|---|
| QActin | Active comparator | Cucumber extract Receives: Dietary Supplement: Q Actin |
| placebo | Placebo comparator | Placebo capsule Receives: Dietary Supplement: Q Actin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint pain
WOMAC
Measured: 8 weeks
Secondary outcomes (1)
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study startFeb 2024 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Joint PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jacksonville University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246383
- Sponsor's protocol ID
- JacksonvilleU
- Status last verified
- Jan 2024
- First submitted
- 22 Jan 2024
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only group data will be shared
Publications
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.
PubMed 40636535
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Standardised Ido-BR1 Cucumber Extract (Q-ActinTM) on Mild to Moderate Joint Pain: A Randomized Double-blind Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT06246383
- Acronym / sponsor ID
- JacksonvilleU
- Conditions
- Joint Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Jacksonville UniversityUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QActin | Active comparator | Dietary Supplement: Q ActinCucumber extract |
| placebo | Placebo comparator | Dietary Supplement: Q ActinPlacebo capsule |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
- 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).
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Q Actincucumber extract | Dietary supplement | QActin, placebo |
Primary outcome
Joint pain
Time frame: 8 weeks
WOMAC
1 secondary outcome
mood, sleep, daytime activity, pain perceptions, daytime fatigue, anxiety, perceived stress, pain perceptions, health-related quality of life.
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Derived from this study: PubMed 40636535Hausenblas 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.
- Individual participant dataSharing planned: Yes. Only group data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Q Actin in people with Joint Pain, run by Jacksonville University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint pain (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06246383, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.