<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03041077</url>
  </required_header>
  <id_info>
    <org_study_id>17-0081</org_study_id>
    <nct_id>NCT03041077</nct_id>
  </id_info>
  <brief_title>Influence of Instaflex Advanced Supplement on Joint Function</brief_title>
  <official_title>Influence of Instaflex Advanced Supplement on Joint Function: A Randomized, Placebo-controlled Community Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Appalachian State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Direct Digital</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Appalachian State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Joint discomfort is reported by 32% of U.S. adults, and increases with age. The knee is the&#xD;
      most common site of joint discomfort regardless of age. Nearly half of people with knee joint&#xD;
      discomfort use natural supplements to alleviate symptoms, but more research is needed to&#xD;
      determine their effectiveness. In a previous study, we measured the effect of 8-weeks&#xD;
      ingestion of a commercialized joint support dietary supplement (InstaflexTM Joint Support,&#xD;
      Direct Digital, Charlotte, NC) compared to placebo on joint discomfort, stiffness, and&#xD;
      function in adults with self-reported joint discomfort. This study will be repeated using&#xD;
      Instaflex Advanced, with a longer 12-week time period. The Instaflex Advanced supplement&#xD;
      includes six products: turmeric, resveratrol, Boswellia serrata, collagen, hyaluronic acid,&#xD;
      and black pepper extract. This unique blend may improve joint function and increase mobility,&#xD;
      but has not yet been tested in humans using a randomized, double-blinded, placebo-controlled&#xD;
      research design. The primary purpose of this study is to assess the effect of 12-weeks&#xD;
      ingestion of the Instaflex Advanced supplement compared to placebo in improving knee function&#xD;
      in adults with self-reported knee joint discomfort.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The research procedures will be conducted at the Human Performance Laboratory (Room 1201,&#xD;
      Plants for Human Health Institute Building, 600 Laureate Way), operated by Appalachian State&#xD;
      University at the North Carolina Research Campus (NCRC) in Kannapolis, NC. Subjects will come&#xD;
      here for orientation/baseline testing and then 3 other lab visits (each session will take&#xD;
      about 30 minutes). The total amount of time study participants will be asked to volunteer for&#xD;
      this study is about 2 hours at the Human Performance Laboratory (over a 12-week period).&#xD;
      Participants will also take a daily supplement for 12 weeks and keep compliant with this&#xD;
      regimen.&#xD;
&#xD;
      Lab visit testing sequence:&#xD;
&#xD;
        1. First visit:&#xD;
&#xD;
             1. Consent form&#xD;
&#xD;
             2. Medical health questionnaire to verify medical history, and lifestyle habits.&#xD;
&#xD;
             3. Questionnaire for previous 4-weeks symptoms.&#xD;
&#xD;
             4. Height, weight, and percent body fat (BIA).Testing will take place behind a&#xD;
                screened area of the lab to maintain privacy.&#xD;
&#xD;
             5. Questionnaires: WOMAC, visual pain scale, POMS.&#xD;
&#xD;
             6. Receive supplement organizer tray with 4-weeks supply (and instructions).&#xD;
&#xD;
             7. After a practice trial, study participants will walk as quickly and far as they can&#xD;
                on a track for 6 minutes. Total distance covered in 6 minutes will be recorded.&#xD;
&#xD;
        2. 4 weeks, 8-weeks, 12 weeks (second, third, and fourth lab visits):&#xD;
&#xD;
             1. Symptoms log for previous 4-weeks symptomatology.&#xD;
&#xD;
             2. Height, weight, and percent body fat.&#xD;
&#xD;
             3. Questionnaires: WOMAC, visual pain scale, POMS.&#xD;
&#xD;
             4. Receive supplement organizer tray with 4-weeks supply (and instructions) during&#xD;
                second and third lab visits.&#xD;
&#xD;
             5. 6-minute walk test&#xD;
&#xD;
      Supplements:&#xD;
&#xD;
      Supplements (Instaflex Advanced, placebo) will be contained in identical looking capsules and&#xD;
      organized by day of the week in supplement organizer trays. Study participants will take 1&#xD;
      capsule each day in the morning. The placebo capsules contain magnesium stearate, an inert&#xD;
      substance. The Instaflex Advanced supplement ingredients include: turmeric, resveratrol,&#xD;
      Boswellia serrata, collagen, hyaluronic acid, and black pepper extract. Compliance will be&#xD;
      monitored with bi-weekly email messages, and by counting unused capsules when the supplement&#xD;
      trays every 4 weeks. Acetaminophen, as found in Tylenol, will be allowed as a rescue medicine&#xD;
      for pain during the study as needed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">September 30, 2017</completion_date>
  <primary_completion_date type="Actual">June 30, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in WOMAC total score</measure>
    <time_frame>Change from baseline WOMAC total score at 4 weeks, 8 weeks, 12 weeks</time_frame>
    <description>WOMAC questionnaire responses pre-study, 4 weeks, 8 weeks, 12 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>WOMAC subscales of pain, stiffness, and physical function</measure>
    <time_frame>Change from baseline WOMAC subscales at 4 weeks, 8 weeks, 12 weeks</time_frame>
    <description>WOMAC questionnaire subscale responses pre-study, 4 weeks, 8 weeks, 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Pain Scale</measure>
    <time_frame>Change from baseline visual pain scale at 4 weeks, 8 weeks, 12 weeks</time_frame>
    <description>10-point Likert-type scale for knee pain severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Profile of Mood States (POMS)</measure>
    <time_frame>Change from baseline POMS at 4 weeks, 8 weeks, 12 weeks</time_frame>
    <description>Assessment of mood state</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6 minute Walk Test</measure>
    <time_frame>Change from baseline 6 minute walk test at 4 weeks, 8 weeks, 12 weeks</time_frame>
    <description>Maximum distance covered during 6 minutes of walking</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Knee Discomfort</condition>
  <arm_group>
    <arm_group_label>Instaflex Advanced</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dietary supplement: Joint function</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Dietary supplement: Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Instaflex Advanced</intervention_name>
    <description>Joint function</description>
    <arm_group_label>Instaflex Advanced</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female adult&#xD;
&#xD;
          -  Age 50-75 years&#xD;
&#xD;
          -  Self-reported history (&gt;3 months) of joint discomfort in the knees. NOTE: the severity&#xD;
             of knee discomfort will be determined through a questionnaire called the WOMAC, and&#xD;
             should be at least 2 points (indicating mild knee discomfort or greater).&#xD;
&#xD;
          -  No history of regular use of non-steroidal anti-inflammatory drugs (NSAIDs) use (e.g.,&#xD;
             ibuprofen, aspirin) during the previous two weeks, and willingness to avoid the use of&#xD;
             NSAIDs during the 12-week study.&#xD;
&#xD;
          -  Not on other medications (e.g., analgesic gels, arthritis medications, other&#xD;
             anti-inflammatory drugs) or supplements (in particular, glucosamine and chondroitin)&#xD;
             for joint discomfort during the previous two weeks, and a willingness to avoid use of&#xD;
             these during the 12-week study.&#xD;
&#xD;
          -  No serious medical problems (current cancer case, severe rheumatoid arthritis, recent&#xD;
             heart attack, recent stroke, congestive heart failure, ulcers, kidney disease, or&#xD;
             other disease that would interfere with study participation).&#xD;
&#xD;
          -  No psychiatric disorder or other condition that might interfere with self-assessment&#xD;
             ability.&#xD;
&#xD;
          -  Willingness to follow all study procedures including randomization to one of two&#xD;
             groups, and to stay weight stable during the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to comply with study requirements including avoidance of NSAIDs, other&#xD;
             anti-inflammatory medications, or discomfort supplements.&#xD;
&#xD;
          -  Current diagnosis of cardiovascular disease, cancer (except for non-melanoma skin&#xD;
             cancer), severe rheumatoid arthritis, ulcers, kidney disease, psychiatric disorder.&#xD;
&#xD;
          -  For female subjects: Pregnant or nursing, or planning to be pregnant or nursing during&#xD;
             the study.&#xD;
&#xD;
          -  On a weight loss program during the study.&#xD;
&#xD;
          -  Vegetarian or vegan.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Self-reported on questionnaire</gender_description>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David C Nieman, DrPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Appalachian State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Appalachian State University Human Performance Lab, North Carolina Research Campus</name>
      <address>
        <city>Kannapolis</city>
        <state>North Carolina</state>
        <zip>28081</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>January 19, 2018</last_update_submitted>
  <last_update_submitted_qc>January 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No IPD sharing plan</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03041077
org study id: 17-0081
nct id: NCT03041077
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in WOMAC total score
time frame: Change from baseline WOMAC total score at 4 weeks, 8 weeks, 12 weeks
description: WOMAC questionnaire responses pre-study, 4 weeks, 8 weeks, 12 weeks
measure: WOMAC subscales of pain, stiffness, and physical function
time frame: Change from baseline WOMAC subscales at 4 weeks, 8 weeks, 12 weeks
description: WOMAC questionnaire subscale responses pre-study, 4 weeks, 8 weeks, 12 weeks
measure: Visual Pain Scale
time frame: Change from baseline visual pain scale at 4 weeks, 8 weeks, 12 weeks
description: 10-point Likert-type scale for knee pain severity
measure: Profile of Mood States (POMS)
time frame: Change from baseline POMS at 4 weeks, 8 weeks, 12 weeks
description: Assessment of mood state
measure: 6 minute Walk Test
time frame: Change from baseline 6 minute walk test at 4 weeks, 8 weeks, 12 weeks
description: Maximum distance covered during 6 minutes of walking
arm group label: Instaflex Advanced
arm group type: Experimental
description: Dietary supplement: Joint function
arm group label: Placebo
arm group type: Placebo Comparator
description: Dietary supplement: Placebo
intervention type: Dietary Supplement
intervention name: Instaflex Advanced
description: Joint function
arm group label: Instaflex Advanced
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo
arm group label: Placebo
criteria: 
gender: All
gender based: Yes
gender description: Self-reported on questionnaire
minimum age: 50 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David C Nieman, DrPH
role: Principal Investigator
affiliation: Appalachian State University
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
ipd description: No IPD sharing plan