Joint PainNCT03209895
Study to Evaluate the Safety and Efficacy of a Proprietary "Joint Health" Dietary Supplement in Subjects With Joint and Connective Tissue Pain
A study testing Joint Health Product and Glucosamine / Chondroitin in people with Joint Pain, run by U.S. Nutraceuticals, LLC at 1 site in United States.
Trial summary
This study is designed to evaluate the effectiveness of a proprietary nutritional supplement that contains Krill Oil (KO), astaxanthin (AX) and hyaluronic acid (HA) to reduce pain and discomfort in participants, compared to an inert placebo (palm oil) control and to a positive control (glucosamine-chondroitin). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Joint Pain
- What is being tested?
- Joint Health Product and Glucosamine / Chondroitin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2010to 13 Jun 2011
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must be able and willing to give Informed Consent.
- Subjects must not have taken anti-inflammatory drugs or supplements for 5 days prior to their initial C-RP blood test, and must refrain from taking these products for the duration of the study.
- Subjects will be required to refrain from taking other pain-reducing agents during the course of the study. This will ensure that the effects observed in the study are the effects of the supplement only, and not of other anti-inflammatory agents
- Subjects must have had knee or hip joint or muscle pain on most days of the previous month; should not have "morning stiffness" for more than 30 minutes; and should experience "stiffness" after resting.
- Subjects must have persistent pain in the knee or hip joints or connective tissue with a pain assessment score of at least 5, but not more than 9 using the WOMAC Pain Assessment and Pain Intensity Rating scale.
- Subjects must be available for and willing to attend all evaluation visits.
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- Subjects must be willing to take/use the test Krill Oil compositions in place of current pain relief medications.
- Subjects may not be on any steroid-based therapies.
- Subjects must have access to a telephone for calling into the Clinical Center as part of test product compliance.
- Subjects must be willing to use appropriate birth control for duration of trial (if appropriate)
- Subjects must be willing to limit consumption of fatty fish for one week prior to and during the study
- Subjects must be willing to refrain from taking any other nutritional supplements related to immune function or pain reduction during the course of this study.
Who cannot join
- Subjects must not be taking remission-inducing drugs such as methotrexate.
- Subjects whose joint pain is not in their knees.
- Subjects who are not willing to forego the use of anti-inflammatory and anti-pain medications or supplements for the duration of the study.
- Subjects who know that their joint pain is due to osteoarthritis or rheumatoid arthritis.
- Women who are pregnant, breastfeeding, or planning to become pregnant during the
- course of the trial
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- Clinical evidence or known history of severe cardiac, pulmonary, gastrointestinal, renal, hepatic or neurological disorders.
- History of allergy to aspirin or NSAlDs.
- Subjects who have undergone total knee replacement in the contra-lateral knee within 6 months prior to the screening visit.
- Subjects who have received an intra-articular corticosteroid injection in a lower joint during the three (3) months prior to the baseline visit.
- Subjects with isolated lateral compartment disease defined by joint space loss in the lateral compartment only.
- Subjects who have received chondrocyte transplants in any lower extremity joint.
- Subjects with co-morbid conditions that restrict knee function.
- Treatment with corticosteroids before washout period
- Patients with infectious arthritis or gout
- Unstable medical conditions.
- Use of omega fatty acid supplements within two weeks of this study
- Clinically significant abnormal laboratory results at baseline
- Participation in a clinical research trial within 30 days prior to randomization
- Allergy, especially from crustaceans, or sensitivity to study supplement ingredients
- Individuals cognitively impaired and/or who are unable to give Informed Consent
- Any other health or mental condition that in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or that may pose significant risk to the subject
- Subjects taking Inflammatory medications, cardiovascular medications, hypotensive medications, blood thinners
- Presence of auto immune diseases, other diseases of the immune systems,
- gastrointestinal diseases, i.e. Irritable bowel syndrome, or disorders of lipid metabolism.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blinded, Placebo Controlled, Human Clinical Study to Evaluate the Safety and Efficacy of a Proprietary "Joint Health" Dietary Supplement in Subjects With Joint and Connective Tissue Pain
This study is designed to evaluate the effectiveness of a proprietary nutritional supplement that contains Krill Oil (KO), astaxanthin (AX) and hyaluronic acid (HA) to reduce pain and discomfort in participants, compared to an inert placebo (palm oil) control and to a positive control (glucosamine-chondroitin). The purpose of the study is to determine if the combination of KO, AX, and HA will benefit participants with joint pain.
- Conditions
- Joint Pain
- Being tested
- Joint Health Product, Placebo, Glucosamine / Chondroitin
- Medical subject headings
- Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joint Health ProductDietary supplement
Also called FlexPro MD
Krill oil, Astaxanthin, Hyaluronic Acid Formulation, 353 mg per day; Softgel capsule
PlaceboDietary supplement
Palm oil Softgel capsule
Glucosamine / ChondroitinDietary supplement
Glucosamine 1500 mg, Chondroitin 1200 mg per day
| Study group | Role | What they receive |
|---|---|---|
| Joint Health Product | Experimental | Not described Receives: Dietary Supplement: Joint Health Product |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Glucosamine / Chondroitin | Active comparator | Not described Receives: Dietary Supplement: Glucosamine / Chondroitin |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC Change
Change in Clinical Coordinator administered pain assessment and pain intensity evaluation over 56 days as determined by the Western Ontario and McMaster Universities Osteoarthritis Index™© (WOMAC)
Measured: Days: 0, 14, 28 and 56
VAS Change
Change in Self-administered Visual Analogue Pain Assessment and Pain Intensity Rating Scale (VAS) over 56 days
Measured: Days: 0, 7, 14, 28, 35, 42 and 56
Secondary outcomes (2)
Blood Chemistry CBC Change
Change in CBC and differentials over 56 days
Measured: Days: 0, 14, 28 and 56
Blood Chemistry hs-CRP Change
Change in hs-CRP over 56 days
Measured: Days: 0, 14, 28 and 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start8 Oct 2010
- Primary completion13 Jun 2011
- Study completion13 Jun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Nutraceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eshwari Koovor, M.B.B.S., Principal investigator, PIHerjit Pannu, MD, Principal investigator, PI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209895
- Sponsor's protocol ID
- KO1
- Status last verified
- Jul 2017
- First submitted
- 29 Jun 2017
- Last updated
- 6 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blinded, Placebo Controlled, Human Clinical Study to Evaluate the Safety and Efficacy of a Proprietary "Joint Health" Dietary Supplement in Subjects With Joint and Connective Tissue Pain
- ClinicalTrials.gov ID
- NCT03209895
- Acronym / sponsor ID
- KO1
- Conditions
- Joint Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- U.S. Nutraceuticals, LLCIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2010 (actual)
- Primary completion
- 13 Jun 2011 (actual)
- Study completion
- 13 Jun 2011 (actual)
- First posted
- 6 Jul 2017 (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.
This study is designed to evaluate the effectiveness of a proprietary nutritional supplement that contains Krill Oil (KO), astaxanthin (AX) and hyaluronic acid (HA) to reduce pain and discomfort in participants, compared to an inert placebo (palm oil) control and to a positive control (glucosamine-chondroitin). The purpose of the study is to determine if the combination of KO, AX, and HA will benefit participants with joint pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Joint Health Product | Experimental | Dietary Supplement: Joint Health Product |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
| Glucosamine / Chondroitin | Active comparator | Dietary Supplement: Glucosamine / Chondroitin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects must be able and willing to give Informed Consent.
- Subjects must not have taken anti-inflammatory drugs or supplements for 5 days prior to their initial C-RP blood test, and must refrain from taking these products for the duration of the study.
- Subjects will be required to refrain from taking other pain-reducing agents during the course of the study. This will ensure that the effects observed in the study are the effects of the supplement only, and not of other anti-inflammatory agents
- Subjects must have had knee or hip joint or muscle pain on most days of the previous month; should not have "morning stiffness" for more than 30 minutes; and should experience "stiffness" after resting.
- Subjects must have persistent pain in the knee or hip joints or connective tissue with a pain assessment score of at least 5, but not more than 9 using the WOMAC Pain Assessment and Pain Intensity Rating scale.
Key exclusion criteria (25 listed)
- Subjects must not be taking remission-inducing drugs such as methotrexate.
- Subjects whose joint pain is not in their knees.
- Subjects who are not willing to forego the use of anti-inflammatory and anti-pain medications or supplements for the duration of the study.
- Subjects who know that their joint pain is due to osteoarthritis or rheumatoid arthritis.
- Women who are pregnant, breastfeeding, or planning to become pregnant during the
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 |
|---|---|---|
| Joint Health ProductAlso: FlexPro MDKrill oil, Astaxanthin, Hyaluronic Acid Formulation, 353 mg per day; Softgel capsule | Dietary supplement | Joint Health Product |
| PlaceboPalm oil Softgel capsule | Dietary supplement | Placebo |
| Glucosamine / ChondroitinGlucosamine 1500 mg, Chondroitin 1200 mg per day | Dietary supplement | Glucosamine / Chondroitin |
Primary outcome
WOMAC Change
Time frame: Days: 0, 14, 28 and 56
Change in Clinical Coordinator administered pain assessment and pain intensity evaluation over 56 days as determined by the Western Ontario and McMaster Universities Osteoarthritis Index™© (WOMAC)
VAS Change
Time frame: Days: 0, 7, 14, 28, 35, 42 and 56
Change in Self-administered Visual Analogue Pain Assessment and Pain Intensity Rating Scale (VAS) over 56 days
2 secondary outcomes
Blood Chemistry CBC Change
Time frame: Days: 0, 14, 28 and 56
Blood Chemistry hs-CRP Change
Time frame: Days: 0, 14, 28 and 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2017.
- Individual participant dataSharing planned: No
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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.
Eshwari Koovor, M.B.B.S. principal investigator
PI
Herjit Pannu, MD principal investigator
PI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Joint Health Product and Glucosamine / Chondroitin in people with Joint Pain, run by U.S. Nutraceuticals, LLC at 1 site in United States.
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 25 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: finished, as of the sponsor's last update on 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
WOMAC Change (time frame: Days: 0, 14, 28 and 56). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2017.