Influence of Instaflex Advanced Supplement on Joint Function
Condition: Knee Discomfort
Study type: Interventional

Summary: 
      Joint discomfort is reported by 32% of U.S. adults, and increases with age. The knee is the
      most common site of joint discomfort regardless of age. Nearly half of people with knee joint
      discomfort use natural supplements to alleviate symptoms, but more research is needed to
      determine their effectiveness. In a previous study, we measured the effect of 8-weeks
      ingestion of a commercialized joint support dietary supplement (InstaflexTM Joint Support,
      Direct Digital, Charlotte, NC) compared to placebo on joint discomfort, stiffness, and
      function in adults with self-reported joint discomfort. This study will be repeated using
      Instaflex Advanced, with a longer 12-week time period. The Instaflex Advanced supplement
      includes six products: turmeric, resveratrol, Boswellia serrata, collagen, hyaluronic acid,
      and black pepper extract. This unique blend may improve joint function and increase mobility,
      but has not yet been tested in humans using a randomized, double-blinded, placebo-controlled
      research design. The primary purpose of this study is to assess the effect of 12-weeks
      ingestion of the Instaflex Advanced supplement compared to placebo in improving knee function
      in adults with self-reported knee joint discomfort.
    

Detailed description: 
      The research procedures will be conducted at the Human Performance Laboratory (Room 1201,
      Plants for Human Health Institute Building, 600 Laureate Way), operated by Appalachian State
      University at the North Carolina Research Campus (NCRC) in Kannapolis, NC. Subjects will come
      here for orientation/baseline testing and then 3 other lab visits (each session will take
      about 30 minutes). The total amount of time study participants will be asked to volunteer for
      this study is about 2 hours at the Human Performance Laboratory (over a 12-week period).
      Participants will also take a daily supplement for 12 weeks and keep compliant with this
      regimen.

      Lab visit testing sequence:

        1. First visit:

             1. Consent form

             2. Medical health questionnaire to verify medical history, and lifestyle habits.

             3. Questionnaire for previous 4-weeks symptoms.

             4. Height, weight, and percent body fat (BIA).Testing will take place behind a
                screened area of the lab to maintain privacy.

             5. Questionnaires: WOMAC, visual pain scale, POMS.

             6. Receive supplement organizer tray with 4-weeks supply (and instructions).

             7. After a practice trial, study participants will walk as quickly and far as they can
                on a track for 6 minutes. Total distance covered in 6 minutes will be recorded.

        2. 4 weeks, 8-weeks, 12 weeks (second, third, and fourth lab visits):

             1. Symptoms log for previous 4-weeks symptomatology.

             2. Height, weight, and percent body fat.

             3. Questionnaires: WOMAC, visual pain scale, POMS.

             4. Receive supplement organizer tray with 4-weeks supply (and instructions) during
                second and third lab visits.

             5. 6-minute walk test

      Supplements:

      Supplements (Instaflex Advanced, placebo) will be contained in identical looking capsules and
      organized by day of the week in supplement organizer trays. Study participants will take 1
      capsule each day in the morning. The placebo capsules contain magnesium stearate, an inert
      substance. The Instaflex Advanced supplement ingredients include: turmeric, resveratrol,
      Boswellia serrata, collagen, hyaluronic acid, and black pepper extract. Compliance will be
      monitored with bi-weekly email messages, and by counting unused capsules when the supplement
      trays every 4 weeks. Acetaminophen, as found in Tylenol, will be allowed as a rescue medicine
      for pain during the study as needed.
    

Intervention name(s): Instaflex Advanced; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Joint function; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment