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Instaflex and Joint Pain in Community Adults

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ClinicalTrials.gov Identifier: NCT01956500
Recruitment Status : Completed
First Posted : October 8, 2013
Last Update Posted : October 8, 2013
Sponsor:
Collaborator:
Direct Digital
Information provided by (Responsible Party):
Appalachian State University

Brief Summary:
The primary purpose of this study is to assess the effect of 8-weeks ingestion of the Instaflex Joint Support supplement (Direct Digital, Charlotte, NC) compared to placebo on joint pain, stiffness, and function (questionnaires and 6-min walk test) and blood inflammation biomarkers in adults with self-reported joint pain.

Condition or disease Intervention/treatment Phase
Joint Pain, Stiffness, Function Dietary Supplement: Instaflex Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Instaflex Joint Support Supplement on Joint Pain, Stiffness, Function, and Inflammation: a Randomized, Placebo-controlled Community Trial
Study Start Date : April 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Instaflex
Instaflex Joint Support supplement (3 capsules per day for 8 weeks)
Dietary Supplement: Instaflex
The Instaflex supplement contained the following ingredients (in 3 capsules): Glucosamine sulfate (1500 mg), methylsulfonylmethane (MSM) (500 mg), white willow bark extract (standardized to 15% salicin) (250 mg), ginger root concentrate (50 mg), boswella serrata extract (standardized to 65% boswellic acid) (125 mg), turmeric root extract (50 mg), cayenne 40m H.U. (50 mg), and hyaluronic acid (4.0 mg).
Other Name: Instaflex Joint Support dietary supplement

Placebo Comparator: Placebo
Placebo (3 capsules per day for 8 weeks)
Dietary Supplement: Placebo
The placebo capsules will contain magnesium stearate, an inert substance.
Other Name: Placebo supplement




Primary Outcome Measures :
  1. Joint pain and function [ Time Frame: Change in joint pain and function at 8 weeks ]
    Assessed through questionnaires


Secondary Outcome Measures :
  1. Systemic inflammation [ Time Frame: Change in systemic inflammation at 8 weeks ]
    Serum CRP and plasma cytokines (9 total)

  2. Safety [ Time Frame: Change in safety outcomes at 8 weeks ]
    Symptoms logs and diagnostic chemistries



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female
  • ages 50-75 years
  • history (>3 months) joint pain, knees, hip, ankles, shoulders, or hands
  • willingness to avoid NSAIDs use during the 8-week study
  • willingness to avoid other anti-inflammatory medications
  • agree to stay weight stable during the 8-week study
  • willing to follow all study procedures, including randomization to one of two groups
  • able to walk for at least 6 min at a moderate-to-brisk pace

Exclusion Criteria:

  • history of regular NSAID use during the previous two weeks
  • use of 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
  • serious medical problems (current cancer case, severe rheumatoid arthritis, recent heart attack, recent stroke, congestive heart failure, ulcers, kidney disease, or other disease that will interfere with study participation).
  • psychiatric disorder or other condition that might interfere with self-assessment ability.
  • history of allergic reactions to shellfish products.
  • history of allergic reactions to products containing aspirin.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01956500


Locations
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United States, North Carolina
ASU Human Performance Laboratory, North Carolina Research Campus
Kannapolis, North Carolina, United States, 28081
Sponsors and Collaborators
Appalachian State University
Direct Digital
Investigators
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Principal Investigator: David C. Nieman, DrPH Appalachian State University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Appalachian State University
ClinicalTrials.gov Identifier: NCT01956500     History of Changes
Other Study ID Numbers: 13-0173
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: October 8, 2013
Last Verified: October 2013

Keywords provided by Appalachian State University:
glucosamine
inflammation
quality of life
physical function

Additional relevant MeSH terms:
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Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms