<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/NCT03781999</url>
  </required_header>
  <id_info>
    <org_study_id>Actiful_001</org_study_id>
    <nct_id>NCT03781999</nct_id>
  </id_info>
  <brief_title>The Effect of a Combination of Orange- and Pomegranate Actives on Physical Fitness in Elderly People</brief_title>
  <official_title>The Effect of a Combination of Orange- and Pomegranate Actives on Physical Fitness in Elderly People</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BioActor</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BioActor</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>
      The primary objective of this study is to determine the effect of daily supplementation of a&#xD;
      combined orange- and pomegranate extract for a period of 4 weeks on physical fitness compared&#xD;
      to placebo.&#xD;
&#xD;
      In this crossover study, participants will daily receive either a placebo or Actiful®, a&#xD;
      supplement containing 500 mg orange extract and 200 mg pomegranate actives, for 4 weeks&#xD;
      followed by a wash-out period of 4 to 8 weeks. Subsequently, the second intervention period&#xD;
      of 4 weeks (active product or placebo) will take place. The product and placebo will be&#xD;
      supplied in capsules that participants can ingest with a glas of water (daily, prior to&#xD;
      breakfast).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dietary habits and physical activity are two important components of a healthy lifestyle.&#xD;
      Targeted nutritional interventions may improve health and stimulate physical activity. Both&#xD;
      orange extracts and pomegranate concentrate have been shown to exert beneficial effects on&#xD;
      health and exercise performance. However, the effects of a combination of the two extracts on&#xD;
      exercise and physical activity have not been investigated yet. It is expected that this&#xD;
      combination may be an effective dietary way to improve exercise performance, physical&#xD;
      activity in the free-living state, and quality of life in a middle aged population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 25, 2018</start_date>
  <completion_date type="Actual">January 17, 2019</completion_date>
  <primary_completion_date type="Actual">January 17, 2019</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>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>6 Minute Walking Test</measure>
    <time_frame>0-4-8-12 weeks</time_frame>
    <description>Participants have to walk for 6 minutes, as fast as possible. Total distance will be measured.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Senior Fitness test</measure>
    <time_frame>0-4-8-12 weeks</time_frame>
    <description>Fitness tests to see if Actiful improves physical activity level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily physical activity measured by accelerometers</measure>
    <time_frame>0-4-8-12 weeks</time_frame>
    <description>Accelerometer is worn for 7 days prior to each testing day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life questionnaire - WHOQOL-100</measure>
    <time_frame>0-4-8-12 weeks</time_frame>
    <description>Participants will be asked to fill out the WHOQOL-100 questionnaire to determine quality of life. Scale from 1-5 (disagree-agree)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of blood marker TAC</measure>
    <time_frame>0-4-8-12 weeks</time_frame>
    <description>Total antioxidant capacity measurement in plasma</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Fitness</condition>
  <arm_group>
    <arm_group_label>Actiful</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>a supplement containing 500 mg orange extract and 200 mg pomegranate actives</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>Actiful</intervention_name>
    <description>supplement containing 500 mg orange extract and 200 mg pomegranate actives</description>
    <arm_group_label>Actiful</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Maltodextrin</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  60 - 75 years old&#xD;
&#xD;
          -  non smoking&#xD;
&#xD;
          -  BMI 18 -28 kg/m²&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to test product/placebo or citrus fruits&#xD;
&#xD;
          -  BMI lower than 18 or higher than 28&#xD;
&#xD;
          -  Recent muscle injury in less than one month before the start of the study&#xD;
&#xD;
          -  Inability to perform the fitness tests&#xD;
&#xD;
          -  Medical conditions that might influence outcome measure or participant safety during&#xD;
             testing, including but not limited to: severe cardiovascular disease, cancer,&#xD;
             Parkinson's disease. To be decided by PI.&#xD;
&#xD;
          -  High blood pressure (systolic ≥ 140 mmHg, diastolic ≥ 90 mmHg)&#xD;
&#xD;
          -  Use of medication that may interfere with the study results, use of beta-blockers&#xD;
&#xD;
          -  Administration of investigational drugs or participation in any scientific&#xD;
             intervention study which may interfere with this study (to be decided by the principle&#xD;
             investigator), in the 180 days prior to the study&#xD;
&#xD;
          -  Abuse of products; alcohol (&gt; 20 alcoholic units per week) and drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Freddy Troost, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maastricht University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BioActor</name>
      <address>
        <city>Maastricht</city>
        <zip>6229GS</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>June 20, 2019</last_update_submitted>
  <last_update_submitted_qc>June 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Performance</keyword>
  <keyword>Polyphenols</keyword>
  <keyword>Nutrition</keyword>
  <keyword>Sports</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/NCT03781999
org study id: Actiful_001
nct id: NCT03781999
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective of this study is to determine the effect of daily supplementation of a
      combined orange- and pomegranate extract for a period of 4 weeks on physical fitness compared
      to placebo.

      In this crossover study, participants will daily receive either a placebo or Actiful®, a
      supplement containing 500 mg orange extract and 200 mg pomegranate actives, for 4 weeks
      followed by a wash-out period of 4 to 8 weeks. Subsequently, the second intervention period
      of 4 weeks (active product or placebo) will take place. The product and placebo will be
      supplied in capsules that participants can ingest with a glas of water (daily, prior to
      breakfast).
Dietary habits and physical activity are two important components of a healthy lifestyle.
      Targeted nutritional interventions may improve health and stimulate physical activity. Both
      orange extracts and pomegranate concentrate have been shown to exert beneficial effects on
      health and exercise performance. However, the effects of a combination of the two extracts on
      exercise and physical activity have not been investigated yet. It is expected that this
      combination may be an effective dietary way to improve exercise performance, physical
      activity in the free-living state, and quality of life in a middle aged population.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: 6 Minute Walking Test
time frame: 0-4-8-12 weeks
description: Participants have to walk for 6 minutes, as fast as possible. Total distance will be measured.
measure: Senior Fitness test
time frame: 0-4-8-12 weeks
description: Fitness tests to see if Actiful improves physical activity level
measure: Daily physical activity measured by accelerometers
time frame: 0-4-8-12 weeks
description: Accelerometer is worn for 7 days prior to each testing day
measure: Quality of life questionnaire - WHOQOL-100
time frame: 0-4-8-12 weeks
description: Participants will be asked to fill out the WHOQOL-100 questionnaire to determine quality of life. Scale from 1-5 (disagree-agree)
measure: Concentration of blood marker TAC
time frame: 0-4-8-12 weeks
description: Total antioxidant capacity measurement in plasma
arm group label: Actiful
arm group type: Experimental
description: a supplement containing 500 mg orange extract and 200 mg pomegranate actives
arm group label: Placebo
arm group type: Placebo Comparator
description: Maltodextrin
intervention type: Dietary Supplement
intervention name: Actiful
description: supplement containing 500 mg orange extract and 200 mg pomegranate actives
arm group label: Actiful
intervention type: Other
intervention name: Placebo
description: Maltodextrin
arm group label: Placebo
criteria: 
gender: All
minimum age: 60 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Freddy Troost, Dr
role: Principal Investigator
affiliation: Maastricht University
facility: 
country: Netherlands
responsible party type: Sponsor
sharing ipd: No