<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/NCT03272867</url>
  </required_header>
  <id_info>
    <org_study_id>14TGO01</org_study_id>
    <nct_id>NCT03272867</nct_id>
  </id_info>
  <brief_title>Effect of an Anti-ageing Supplement on Oxidative Stress</brief_title>
  <acronym>PromAge</acronym>
  <official_title>Cross-over Randomized Placebo-controlled Pilot Study to Determine the Effect in Healthy Elderly Volunteers of the Anti-ageing Supplement &quot;Promanna™&quot; on a Number of Biomarkers Associated With DNA-damage and Oxidative Stress (PromAge)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medical Center Groningen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medical Center Groningen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot study serves to investigate whether ProManna intake leads to any changes in&#xD;
      baseline levels for oxidative stress markers. In addition, biomarker responses following&#xD;
      oxidative stress challenge tests will be assessed in subjects taking ProManna versus placebo&#xD;
      supplements.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ageing is characterized by a progressive decline in the efficiency of physiological function&#xD;
      and by the increased susceptibility to disease and death. Most ageing-associated diseases&#xD;
      develop silently for many years before symptoms appear, leading to irreversible pathological&#xD;
      conditions. Examples of these diseases are Alzheimer's, Parkinson's, osteoporosis, diabetes,&#xD;
      cardiovascular disease and also cancer. Typically, patients are treated when most of the&#xD;
      damage has already occurred, and existing drugs can rarely cure these diseases, but merely&#xD;
      slow down further progression of the disease. Therefore, preventive measures that may delay&#xD;
      the onset of these diseases can hold the best promise for healthy ageing. of the most&#xD;
      plausible and acceptable explanations for the mechanistic basis of aging is the &quot;free radical&#xD;
      theory of aging&quot;. This theory postulates that aging and its related diseases are the&#xD;
      consequence of free radical-induced damage to cellular macromolecules and the inability to&#xD;
      counterbalance these changes by endogenous anti-oxidant defences. ProManna is a novel and&#xD;
      safe food supplement that aims to decrease free radical-induced damage, thereby contributing&#xD;
      to healthy ageing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in oxidative stress markers</measure>
    <time_frame>Two weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in oxidative stress following a hyperoxia or glucose challenge</measure>
    <time_frame>Two weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in experienced health</measure>
    <time_frame>Two weeks</time_frame>
    <description>Rand-36-item Health Survey (SF-36)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Healthy Volunteers</condition>
  <condition>Age Group: 60-70</condition>
  <condition>Overweight</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One group of volunteers will ingest a powder with dose of 6.1 g ProManna twice a day for a period of 2 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Another group of volunteers will ingest a powder with the same amount of a placebo twice a day for a periode of 2 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>ProManna</intervention_name>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Intervention group</arm_group_label>
    <other_name>L-proline</other_name>
    <other_name>D-mannitol</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy volunteer aged ≥ 60 to ≤ 70&#xD;
&#xD;
          2. Not involved in intensive sportive activities more than twice a week (e.g. playing&#xD;
             football, tennis, running, cycling-racing, swimming)&#xD;
&#xD;
          3. Stable weight and no intention to lose weight until completion of the study (three&#xD;
             times a day: a normal eating pattern).&#xD;
&#xD;
          4. Two weeks before the start and during the study no use of over the counter medication,&#xD;
             prescribed medication, herbal medication or dietary supplements which in the&#xD;
             investigator's opinion could affect study results, or which could be affected by the&#xD;
             study product (i.e. absorption of oral medication will be influenced by D-Mannitol).&#xD;
             Exception for sporadic use of paracetamol and/or treating an AE.&#xD;
&#xD;
          5. Able and motivated to comply with protocol requirements like for instance take the&#xD;
             investigational product the way it is prescribed and to do the tests.&#xD;
&#xD;
          6. Voluntary signed written informed consent form (ICF) before the start of the pilot.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. BMI &lt; 25 or &gt; 30 kg/m2&#xD;
&#xD;
          2. Not being able to fast overnight (12 hours)&#xD;
&#xD;
          3. Diabetes mellitus&#xD;
&#xD;
          4. Gastrointestinal disorders&#xD;
&#xD;
          5. Undergone digestive tract surgery (except appendectomy)&#xD;
&#xD;
          6. Clinically significant inflammatory disease (possibly interfering with measurement of&#xD;
             parameters in this study)&#xD;
&#xD;
          7. Weed smoking&#xD;
&#xD;
          8. Donation of blood within the last 3 months prior to admission to the clinic&#xD;
&#xD;
          9. Participation to another clinical study within 90 days before enrolment&#xD;
&#xD;
         10. Clinically relevant abnormalities in clinical chemistry or positive HIV, HbsAg and/or&#xD;
             HepC at screening&#xD;
&#xD;
         11. Positive drug screen or alcohol breath test at D-1&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UMCG</name>
      <address>
        <city>Groningen</city>
        <zip>9700RB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 2, 2017</study_first_submitted>
  <study_first_submitted_qc>September 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>September 2, 2017</last_update_submitted>
  <last_update_submitted_qc>September 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Center Groningen</investigator_affiliation>
    <investigator_full_name>Prof. dr. S.J.L. Bakker, MD, PhD</investigator_full_name>
    <investigator_title>Prof. dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mannitol</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03272867
org study id: 14TGO01
nct id: NCT03272867
lead sponsor: 
has dmc: Yes
This pilot study serves to investigate whether ProManna intake leads to any changes in
      baseline levels for oxidative stress markers. In addition, biomarker responses following
      oxidative stress challenge tests will be assessed in subjects taking ProManna versus placebo
      supplements.
Ageing is characterized by a progressive decline in the efficiency of physiological function
      and by the increased susceptibility to disease and death. Most ageing-associated diseases
      develop silently for many years before symptoms appear, leading to irreversible pathological
      conditions. Examples of these diseases are Alzheimer's, Parkinson's, osteoporosis, diabetes,
      cardiovascular disease and also cancer. Typically, patients are treated when most of the
      damage has already occurred, and existing drugs can rarely cure these diseases, but merely
      slow down further progression of the disease. Therefore, preventive measures that may delay
      the onset of these diseases can hold the best promise for healthy ageing. of the most
      plausible and acceptable explanations for the mechanistic basis of aging is the "free radical
      theory of aging". This theory postulates that aging and its related diseases are the
      consequence of free radical-induced damage to cellular macromolecules and the inability to
      counterbalance these changes by endogenous anti-oxidant defences. ProManna is a novel and
      safe food supplement that aims to decrease free radical-induced damage, thereby contributing
      to healthy ageing.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Changes in oxidative stress markers
time frame: Two weeks
measure: Changes in oxidative stress following a hyperoxia or glucose challenge
time frame: Two weeks
measure: Changes in experienced health
time frame: Two weeks
description: Rand-36-item Health Survey (SF-36)
arm group label: Intervention group
arm group type: Experimental
description: One group of volunteers will ingest a powder with dose of 6.1 g ProManna twice a day for a period of 2 weeks
arm group label: Control group
arm group type: Placebo Comparator
description: Another group of volunteers will ingest a powder with the same amount of a placebo twice a day for a periode of 2 weeks
intervention type: Dietary Supplement
intervention name: ProManna
arm group label: Control group
arm group label: Intervention group
other name: L-proline
other name: D-mannitol
criteria: 
gender: All
minimum age: 60 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: University Medical Center Groningen
investigator full name: Prof. dr. S.J.L. Bakker, MD, PhD
investigator title: Prof. dr.
mesh term: Overweight
mesh term: Mannitol