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

NCT03209895 | Completed

• 1 other identifier: KO1
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief 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). 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

Outcome Measures

Primary Outcomes (2)

• 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)

  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

  Days: 0, 7, 14, 28, 35, 42 and 56

Secondary Outcomes (2)

• Blood Chemistry CBC Change

  Days: 0, 14, 28 and 56

• Blood Chemistry hs-CRP Change

  Days: 0, 14, 28 and 56

Study Arms (3)

Joint Health Product

EXPERIMENTAL

Dietary Supplement: Joint Health Product

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Glucosamine / Chondroitin

ACTIVE COMPARATOR

Dietary Supplement: Glucosamine / Chondroitin

Interventions

Joint Health Product DIETARY_SUPPLEMENT

Krill oil, Astaxanthin, Hyaluronic Acid Formulation, 353 mg per day; Softgel capsule

Also known as: FlexPro MD

Joint Health Product

Placebo DIETARY_SUPPLEMENT

Palm oil Softgel capsule

Placebo

Glucosamine / Chondroitin DIETARY_SUPPLEMENT

Glucosamine 1500 mg, Chondroitin 1200 mg per day

Glucosamine / Chondroitin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• U.S. Nutraceuticals, LLC: lead

Study Sites (1)

1621 Bridgeway

Sausalito, California, 94965, United States

Location

MeSH Terms

Conditions

Arthralgia

Interventions

Glucosamine; Chondroitin

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hexosamines; Amino Sugars; Carbohydrates; Glycosaminoglycans; Polysaccharides

Study Officials

• Eshwari Koovor, M.B.B.S.

  PI

  PRINCIPAL INVESTIGATOR

• Herjit Pannu, MD

  PI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: July 6, 2017
• Study Start: October 8, 2010
• Primary Completion: June 13, 2011
• Study Completion: June 13, 2011
• Last Updated: July 6, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)