Study to Evaluate the Safety and Efficacy of a Proprietary "Joint Health" Dietary Supplement in Subjects With Joint and Connective Tissue Pain

July 3, 2017 updated by: U.S. Nutraceuticals, LLC

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
135

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sausalito, California, United States, 94965
        • 1621 Bridgeway

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Placebo
Dietary supplement: Placebo
Palm oil Softgel capsule
EXPERIMENTAL: Joint Health Product
Dietary supplement: Joint Health Product
Krill oil, Astaxanthin, Hyaluronic Acid Formulation, 353 mg per day; Softgel capsule
Other Names:
  • FlexPro MD
ACTIVE_COMPARATOR: Glucosamine / Chondroitin
Dietary supplement: Glucosamine / Chondroitin
Glucosamine 1500 mg, Chondroitin 1200 mg per day

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Days: 0, 14, 28 and 56
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
Days: 0, 7, 14, 28, 35, 42 and 56

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood Chemistry CBC Change
Time Frame: Days: 0, 14, 28 and 56
Change in CBC and differentials over 56 days
Days: 0, 14, 28 and 56
Blood Chemistry hs-CRP Change
Time Frame: Days: 0, 14, 28 and 56
Change in hs-CRP over 56 days
Days: 0, 14, 28 and 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
U.S. Nutraceuticals, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eshwari Koovor, M.B.B.S., PI
  • Principal Investigator: Herjit Pannu, MD, PI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 8, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 13, 2011

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 13, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KO1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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