Instaflex and Joint Pain in Community Adults
Condition: Joint Pain, Stiffness, Function
MeSH terms: Arthralgia
Study type: Interventional

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 description: 
      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 (bioelectrical impedance, Tanita scale)

             5. Questionnaires: Western Ontario and McMaster Universities Arthritis Index (WOMAC),
                Short Form (36) Health Survey (SF-36), and Measure of Intermittent and Constant
                Osteoarthritis Pain (ICOAP).

             6. Blood sample (followed by a glass of orange juice)

             7. 6-minute walk test (at the local YMCA track) (one practice trial, and then repeat
                for test).

             8. Receive supplement organizer tray with 8-weeks supply (and instructions)

        2. 8-week study:

           a. Subjects will be contacted via email every 2 weeks to monitor compliance and fill in
           symptom logs.

        3. Second lab visit:

             1. Same as first lab visit, except for removal of steps "a,b, and h".

      Supplements:

      Supplements (Instaflex, placebo) will be prepared in colored gel capsules (3 per day,
      identical looking), and given to the subjects in supplement organizer trays. Subjects will
      take 3 capsules/day: one capsule each in the morning, at noontime, and in the evening. The
      placebo capsules will contain magnesium stearate, an inert substance.

      Compliance:

      Compliance will be monitored with bi-weekly email messages, and by counting unused capsules
      when subjects return the supplement trays at the end of the 8-week study. If subjects miss
      one, two, or three days of taking supplements, subjects will be asked to double up usage
      until back on schedule. Subjects missing more than three days of taking the supplements will
      be asked to leave the study.

      1. Instaflex Joint Support Supplement

      A serving size is 3 capsules, and contains the following ingredients:

      Glucosamine Sulfate 1500 mg Methylsulfonylmethane 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 Hyaluronic Acid 4.0 mg Other Ingredients: Rice Flour, Gelatin, Vegetable Magnesium
      Stearate, Silicon Dioxide
    

Intervention name(s): Instaflex; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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).; The placebo capsules will contain magnesium stearate, an inert substance.
Other intervention name(s): Instaflex Joint Support dietary supplement; Placebo supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: glucosamine; inflammation; quality of life; physical function