Clinical Trial: Instaflex and Joint Pain in Community Adults

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Influence of Instaflex Joint Support Supplement on Joint Pain, Stiffness, Function, and Inflammation: a Randomized, Placebo-controlled Community Trial

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.

Detailed Summary:

Allocation: Randomized. Subjects will be randomized to one of two groups: placebo or Instaflex Joint Support. Supplements will be administered in double-blinded fashion.

Intervention Model: Instaflex Joint Support supplement for 8 weeks versus placebo.

Sample Size: N=100, with N=50 per group.

Statistical Procedures: 2 x 2 repeated measures analysis of variance (ANOVA).

Study Duration (per subject): 8 weeks.

Blood sample schedule: Blood draws pre- and post-study.

Monitoring adverse events: Subjects will fill in bi-weekly symptom logs to monitor untoward symptoms. Diagnostic chemistry panels will be measured pre- and post-study.

Rescue medication: Paracetamol (i.e., acetaminophen as found in Tylenol) will be allowed as a rescue medicine for pain during the study as needed. Subjects will record paracetamol usage. Paracetamol can relieve pain in mild arthritis but has no effect on the underlying inflammation, redness, and swelling of the joint.

Lab visit testing sequence (at the Kannapolis YMCA, in the afternoon by appointment.):

  1. First visit:

    1. Consent form
    2. Medical health questionnaire to verify medical history, and lifestyle habits.
    3. Symptoms log for previous 2-weeks symptomatology
    4. Height, weight, and percent body fat (bioel
      Sponsor: Appalachian State University

      Current Primary Outcome: Joint pain and function [ Time Frame: Change in joint pain and function at 8 weeks ]

      Assessed through questionnaires


      Original Primary Outcome: Same as current

      Current Secondary Outcome:

      • Systemic inflammation [ Time Frame: Change in systemic inflammation at 8 weeks ]
        Serum CRP and plasma cytokines (9 total)
      • Safety [ Time Frame: Change in safety outcomes at 8 weeks ]
        Symptoms logs and diagnostic chemistries


      Original Secondary Outcome: Same as current

      Information By: Appalachian State University

      Dates:
      Date Received: September 27, 2013
      Date Started: April 2013
      Date Completion:
      Last Updated: October 7, 2013
      Last Verified: October 2013