<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/NCT03034668</url>
  </required_header>
  <id_info>
    <org_study_id>16-1991</org_study_id>
    <nct_id>NCT03034668</nct_id>
  </id_info>
  <brief_title>Botanical Supplement Muscle Function and Lean Body Mass</brief_title>
  <official_title>The Acute and Chronic Influence of a Botanical Supplement on Muscle Function and Lean Body Mass</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Naturex SA</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose: To evaluate the acute and chronic effects of a botanical supplement on strength,&#xD;
      muscle function, and lean body mass&#xD;
&#xD;
      Participants: The acute phase will include 30 participants, and the chronic phase will&#xD;
      include 84 participants. All participants must be healthy recreationally active males between&#xD;
      the ages of 18 and 35 years.&#xD;
&#xD;
      Procedures (methods):&#xD;
&#xD;
      Acute phase: Participants will complete three testing visits as part of as part of a&#xD;
      cross-over design, during which strength and muscle function will be assessed prior to and&#xD;
      following consumption of a supplement. The experimental supplement is a blend of the&#xD;
      botanical extracts; treatment arms will include a full dose (FULL; 350 mg capsule), half dose&#xD;
      (HALF; 175 mg plus maltodextrin), or placebo (PLA; maltodextrin).&#xD;
&#xD;
      Chronic phase: Body composition, muscle cross-sectional area, a complete blood count and&#xD;
      metabolic panel, subjective surveys, and strength will be measured prior to and following an&#xD;
      8-week supervised resistance training program, in conjunction with daily supplementation of&#xD;
      FULL, HALF, or PLA.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">August 2018</completion_date>
  <primary_completion_date type="Actual">August 2018</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>Factorial Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximal Isokinetic Leg Extension strength measured by dynamometry</measure>
    <time_frame>Acute/Immediate</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximal Upper and Lower Body Strength measured by 1 repetition maximum</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bench Press Repetitions to Fatigue</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leg Press Repetitions to Fatigue</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Composition-Lean Mass</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Composition-Fat Mass</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle cross sectional area</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life Score from baseline to 8 weeks</measure>
    <time_frame>baseline, 8 weeks</time_frame>
    <description>Quality of life from a visual analog scale (VAS) 0-100, with 0 = worst quality of life and 100=best quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Felt Arousal score from baseline to 8 weeks</measure>
    <time_frame>baseline, 8 weeks</time_frame>
    <description>Felt arousal scale. Scores range 1-6 with 1 being low arousal and 6 being high. One score selected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mood score from baseline to 8 weeks</measure>
    <time_frame>baseline; 8 weeks</time_frame>
    <description>Mood determined from a VAS. 0-100, with 0 = not depressed at all and 100 = most depressed.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">119</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>CS16-003 Full dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>350 mg capsule QD Rhodiola rosea L. &amp; Rhaptonticum carthamoides extracts</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CS16-003 Half dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>175 mg capsule QD 50% Rhodiola rosea L. &amp; Rhaptonticum carthamoides extracts + 50% Maltodextrin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Maltodextrin</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>CS16-003 Full dose</intervention_name>
    <description>350 mg 'Rhodiola rosea L. &amp; Rhaptonticum carthamoides extracts</description>
    <arm_group_label>CS16-003 Full dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>CS16-003 Half dose</intervention_name>
    <description>175 mg 'Rhodiola rosea L. &amp; Rhaptonticum carthamoides extracts + maltodextrin 175 mg</description>
    <arm_group_label>CS16-003 Half dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Maltodextrin: 350 mg</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Recreationally Active (1- 4 hours of exercise/ sports participation per week and no&#xD;
             more than 1 hour of resistance training exercise per week) for the previous 12 weeks.&#xD;
&#xD;
          -  BMI &lt; 30 kg/m²&#xD;
&#xD;
          -  Have not smoked in the past year.&#xD;
&#xD;
          -  Participant has provided written and dated informed consent to participate in the&#xD;
             study&#xD;
&#xD;
          -  Participant is willing and able to comply with the protocol&#xD;
&#xD;
          -  Participant is apparently healthy and free from disease, as determined by a health&#xD;
             history questionnaire&#xD;
&#xD;
          -  Participant agrees to abstain from caffeine, tobacco, alcohol, and exercise within 24&#xD;
             hours of testing visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant has not used any dietary supplements within 12 weeks prior to enrollment&#xD;
             and will not begin supplementation during the study. Potential supplements include but&#xD;
             are not limited to Beta-alanine, Creatine, HMB, Carnosine, Taurine, androstenedione,&#xD;
             DHEA, Whey protein, or a pre-workout supplement.&#xD;
&#xD;
          -  Participant has gained or lost 10 lbs in the previous 2 months.&#xD;
&#xD;
          -  Participant is currently enrolled in a separate clinical trial.&#xD;
&#xD;
          -  Participant has participated in a clinical trial within the previous 2 months that&#xD;
             includes modifications to their physical and/or diet.&#xD;
&#xD;
          -  Participant has a known allergy or sensitivity to the placebo (maltodextrin) or active&#xD;
             ingredients (Rhodiola &amp; Rhaptonicum)&#xD;
&#xD;
          -  Participant consumes more than 8 cups (1 cup = 6 oz) of coffee per day on a regular&#xD;
             basis&#xD;
&#xD;
          -  Participant consumes more than 3 alcoholic drinks per day.&#xD;
&#xD;
          -  Participant uses recreational drugs daily.&#xD;
&#xD;
          -  Previous physical symptoms causing a physician to recommend you to refrain from&#xD;
             exercise.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Ryan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of North Carolina, Department of Exercise and Sport Science</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>September 17, 2018</last_update_submitted>
  <last_update_submitted_qc>September 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Botanical Supplement</keyword>
  <keyword>Performance-Enhancing Supplement</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03034668
org study id: 16-1991
nct id: NCT03034668
lead sponsor: 
collaborator: 
has dmc: No
Purpose: To evaluate the acute and chronic effects of a botanical supplement on strength,
      muscle function, and lean body mass

      Participants: The acute phase will include 30 participants, and the chronic phase will
      include 84 participants. All participants must be healthy recreationally active males between
      the ages of 18 and 35 years.

      Procedures (methods):

      Acute phase: Participants will complete three testing visits as part of as part of a
      cross-over design, during which strength and muscle function will be assessed prior to and
      following consumption of a supplement. The experimental supplement is a blend of the
      botanical extracts; treatment arms will include a full dose (FULL; 350 mg capsule), half dose
      (HALF; 175 mg plus maltodextrin), or placebo (PLA; maltodextrin).

      Chronic phase: Body composition, muscle cross-sectional area, a complete blood count and
      metabolic panel, subjective surveys, and strength will be measured prior to and following an
      8-week supervised resistance training program, in conjunction with daily supplementation of
      FULL, HALF, or PLA.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Other
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Maximal Isokinetic Leg Extension strength measured by dynamometry
time frame: Acute/Immediate
measure: Maximal Upper and Lower Body Strength measured by 1 repetition maximum
time frame: 8 weeks
measure: Bench Press Repetitions to Fatigue
time frame: 8 weeks
measure: Leg Press Repetitions to Fatigue
time frame: 8 weeks
measure: Body Composition-Lean Mass
time frame: 8 weeks
measure: Body Composition-Fat Mass
time frame: 8 weeks
measure: Muscle cross sectional area
time frame: 8 weeks
measure: Change in Quality of Life Score from baseline to 8 weeks
time frame: baseline, 8 weeks
description: Quality of life from a visual analog scale (VAS) 0-100, with 0 = worst quality of life and 100=best quality of life.
measure: Change in Felt Arousal score from baseline to 8 weeks
time frame: baseline, 8 weeks
description: Felt arousal scale. Scores range 1-6 with 1 being low arousal and 6 being high. One score selected.
measure: Change in Mood score from baseline to 8 weeks
time frame: baseline; 8 weeks
description: Mood determined from a VAS. 0-100, with 0 = not depressed at all and 100 = most depressed.
arm group label: CS16-003 Full dose
arm group type: Experimental
description: 350 mg capsule QD Rhodiola rosea L. & Rhaptonticum carthamoides extracts
arm group label: CS16-003 Half dose
arm group type: Experimental
description: 175 mg capsule QD 50% Rhodiola rosea L. & Rhaptonticum carthamoides extracts + 50% Maltodextrin
arm group label: Placebo
arm group type: Placebo Comparator
description: Maltodextrin
intervention type: Dietary Supplement
intervention name: CS16-003 Full dose
description: 350 mg 'Rhodiola rosea L. & Rhaptonticum carthamoides extracts
arm group label: CS16-003 Full dose
intervention type: Dietary Supplement
intervention name: CS16-003 Half dose
description: 175 mg 'Rhodiola rosea L. & Rhaptonticum carthamoides extracts + maltodextrin 175 mg
arm group label: CS16-003 Half dose
intervention type: Dietary Supplement
intervention name: Placebo
description: Maltodextrin: 350 mg
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eric Ryan, PhD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No