<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/NCT04450979</url>
  </required_header>
  <id_info>
    <org_study_id>AFCRO-063</org_study_id>
    <nct_id>NCT04450979</nct_id>
  </id_info>
  <brief_title>Study to Evaluate Bioactive Peptides' Effect on Digestive Discomfort Symptoms of the Elderly</brief_title>
  <acronym>Inflammaging</acronym>
  <official_title>A Randomised, Double-blinded, Parallel Group, Placebo-Controlled Study to Evaluate the Effects of a Bioactive Peptide on Symptoms of Digestive Discomfort in the Elderly</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nuritas Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Atlantia Food Clinical Trials</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Nuritas Ltd</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial will investigate the potential of a bioactive peptide to reduce symptoms of&#xD;
      digestive discomfort in a generally healthy elderly population. Participants will consume the&#xD;
      bioactive peptide for 12 weeks and various measures indicating an improvement in health and&#xD;
      well being will be taken throughout the trial. It is believed that consumption of the study&#xD;
      product will reduce the severity of digestive discomfort, reduce chronic inflammation,&#xD;
      improve blood glucose metabolism and improve physical performance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Forty subjects aged between 65 and 75 with self-reported symptoms of digestive discomfort&#xD;
      will be randomised. Subjects will be randomised to receive either the Bioactive peptide or&#xD;
      placebo for a total of 12 weeks.&#xD;
&#xD;
      Subjects will undergo an initial phone screen and will be asked questions regarding their age&#xD;
      and their symptoms of digestive discomfort. Eligible subjects will be scheduled for a&#xD;
      screening visit. The study will involve 5 visits over a 13 to 16 week period.&#xD;
&#xD;
      At the screening visit (Visit 1) the inclusion and exclusion criteria will be reviewed and&#xD;
      the overall details of the study will be explained and informed consent obtained. Vitals and&#xD;
      Medical history, demographic data and concomitant medication will be recorded.&#xD;
&#xD;
      Subjects will be asked questions relating to their digestive symptoms, including symptoms of&#xD;
      abdominal pain, discomfort, bloating and flatulence. Subjects will complete the Digestive&#xD;
      Symptom Frequency Questionnaire (DSFQ), the International Physical Activity Questionnaire&#xD;
      (IPAQ) and the Mini-mental State Exam (MMSE) will be administered. The Fried Frailty score&#xD;
      will be completed and the Short Physical Performance Battery (SPPB) test will be performed. A&#xD;
      fasting blood sample (9mls) will be collected and haematology, biochemistry, glucose and&#xD;
      blood lipids will be measured.&#xD;
&#xD;
      Subjects will be provided with a stool collection kit and instructions for collecting and&#xD;
      storing. Subjects will collect a stool sample at home, within 24 hours of their next visit&#xD;
      and bring it to the clinic at their next visit.&#xD;
&#xD;
      If the subject meets the eligibility criteria, they will be invited to participate in the&#xD;
      study and will be given an appointment to return to the study site within 4 weeks for their&#xD;
      baseline/week 0 visit.&#xD;
&#xD;
      Subjects will attend visit 2 fasting. The inclusion and exclusion criteria will be reviewed&#xD;
      and eligibility for study entry confirmed. An Oral Glucose Tolerance Test will be performed.&#xD;
      Haematology, biochemistry and blood lipids will also be measured.&#xD;
&#xD;
      A urine sample will be collected and also stored frozen for analysis of metabolites.&#xD;
&#xD;
      Vitals, anthropometric measurements, concomitant medication and any adverse events will be&#xD;
      recorded and The Short Physical Performance Battery (SPPB) test will be performed.&#xD;
&#xD;
      Subjects will complete the Digestive Symptom Frequency Questionnaire and the hand-grip and&#xD;
      chair-stand tests will be performed. A DEXA scan will be performed and muscle and fat mass&#xD;
      recorded.&#xD;
&#xD;
      Subjects will be randomized to receive the Bioactive peptide or placebo and receive a 4 week&#xD;
      supply of product and instructions for dosing. Subjects will be provided with a stool&#xD;
      collection kit and instructions for collecting and storing. Subjects will collect a stool&#xD;
      sample at home, within 24 hours of their next visit and bring it to the clinic at their next&#xD;
      visit.&#xD;
&#xD;
      Subjects will return for visits at week 4, week 8 and week 12.&#xD;
&#xD;
      A similar regimen will be followed for visits at week 4, week 8 and week 12.&#xD;
&#xD;
      The site, investigator, protocol, informed consent form and any other pertinent documents for&#xD;
      this study will be approved by: Cork Research Ethics Committee of the Cork Teaching&#xD;
      Hospitals, Lancaster Hall, 6 Little Hanover Street, Cork.&#xD;
&#xD;
      The investigator is responsible for ensuring that all source documents (i.e. study and/or&#xD;
      medical records) are completed and maintained according to the study protocol, Good Clinical&#xD;
      Practice (GCP) and are available at the site.&#xD;
&#xD;
      LIST OF ABBREVIATIONS AND DEFINITION OF TERMS&#xD;
&#xD;
      ANCOVA Analysis of co-variance AUC Area Under the Plasma Concentration BMI Body mass index BP&#xD;
      Blood pressure CI Confidence interval CRF Case Report Form CRO Contract Research Organization&#xD;
      EFSA European Food Safety Authority GCP Good Clinical Practice GMP Good Manufacturing&#xD;
      Practice HbAIc Glycated haemoglobin (A1c) ICH International Conference on Harmonization INCI&#xD;
      The International Nomenclature of Cosmetic Ingredients ITT Intent-to-treat kDa Kilodalton kg&#xD;
      Kilogram L Liter MCH Mean corpuscular hemoglobin MCHC Mean corpuscular hemoglobin&#xD;
      concentration MCV Mean corpuscular volume MCPs Marine collagen peptides MedDRA Medical&#xD;
      Dictionary for Regulatory Activities mITT Modified intention-to-treat mL Milliliter mmHg&#xD;
      Millimeter of mercury mmol/mol Millimoles per mole OGTT Oral glucose tolerance test PPP Per&#xD;
      protocol population RDW Red cell distribution width SAE Serious adverse event SAP Statistical&#xD;
      analysis plan VLDL Very low-density lipoprotein WHO World Health Organisation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 14, 2016</start_date>
  <completion_date type="Actual">January 20, 2017</completion_date>
  <primary_completion_date type="Actual">October 28, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
  </study_design_info>
  <primary_outcome>
    <measure>Digestive symptom frequency questionnaire</measure>
    <time_frame>Baseline (week 0) and end of treatment (week 12)</time_frame>
    <description>The primary endpoint is the difference between the change experienced over 12 weeks in the active group versus the change in the placebo group using the digestive symptom frequency questionnaire (DSFQ) at baseline and end of treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To determine the effect of supplementation of a Bioactive Peptide on muscle mass</measure>
    <time_frame>Baseline (week 0) and week 12</time_frame>
    <description>Muscle mass, measured by dual-energy x-ray absorptiometry (DXA) at weeks 0 and 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the effect of supplementation of a Bioactive Peptide on upper body muscle strength</measure>
    <time_frame>Baseline (weeks 0) and week 4, week 8 and week 12</time_frame>
    <description>Upper body muscle strength, measured by the hand-grip test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the effect of supplementation of a Bioactive Peptide on lower body muscle strength</measure>
    <time_frame>Baseline (weeks 0) and week 4, week 8 and week 12</time_frame>
    <description>Lower body muscle strength, measured by the chair stand test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the effect of supplementation of a Bioactive Peptide on physical performance</measure>
    <time_frame>Baseline (weeks 0) and week 12</time_frame>
    <description>Short physical performance battery test score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the effect of supplementation of a Bioactive Peptide on blood glucose</measure>
    <time_frame>Baseline (weeks 0) and week 12</time_frame>
    <description>Glucose as measured by the Oral Glucose Tolerance Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the effect of supplementation of a Bioactive Peptide on blood markers of inflammation</measure>
    <time_frame>Baseline (weeks 0) and week 4, week 8 and week 12</time_frame>
    <description>Inflammatory cytokines (IL6 &amp; IL1R, CRP, TNF)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the effect of supplementation of a Bioactive Peptide on blood lipid</measure>
    <time_frame>Baseline (weeks 0) and week 4, week 8 and week 12</time_frame>
    <description>Lipids (Total cholesterol, LDL, HDL, Triglycerides</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Abdominal Pain</condition>
  <arm_group>
    <arm_group_label>Bioactive hydrolysate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20 g of hydrolysed rice protein</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>20 g micro crystalline cellulose</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Bioactive hydrolysate</intervention_name>
    <description>Participants given a bioactive vegetable hydrolysate to take one dose each morning and one dose each evening for the duration of the study.</description>
    <arm_group_label>Bioactive hydrolysate</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be able to give written informed consent&#xD;
&#xD;
          -  Be between 65 and 75 years of age (inclusive)&#xD;
&#xD;
          -  Have symptoms of digestive pain &amp; discomfort&#xD;
&#xD;
          -  Have a Fried Frailty score of &lt;2&#xD;
&#xD;
          -  Have a Short physical performance battery (SPPB) score of &gt;5 and &lt;10&#xD;
&#xD;
          -  Have a Mini Mental State Exam (MMSE) score &gt;24&#xD;
&#xD;
          -  Have low or moderate activity according to the IPAQ short form&#xD;
&#xD;
          -  Have a BMI &lt;30 kg/m2&#xD;
&#xD;
          -  Be in good general health.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Are less than 65 and greater than 75 years of age&#xD;
&#xD;
          -  Are severely immunocompromised (HIV positive, transplant Subject, on antirejection&#xD;
             medications, on a steroid for &gt;30 days.&#xD;
&#xD;
          -  Have a diagnosis of Irritable Bowel Syndrome&#xD;
&#xD;
          -  Is taking a high dose of statins and/or has changed had their dose modified in the&#xD;
             previous 6 months&#xD;
&#xD;
          -  Is experiencing muscle pain, soreness or muscle loss in the previous 6 months&#xD;
&#xD;
          -  Has a history of drug and / or alcohol abuse at the time of enrolment&#xD;
&#xD;
          -  Has changed their dietary habit within the preceding month&#xD;
&#xD;
          -  Has a known organic disease, including an inflammatory bowel disease, a benign or&#xD;
             malign tumour of intestine or colon and significant systemic disease&#xD;
&#xD;
          -  Subject currently involved in any other clinical trial or having participated in a&#xD;
             trial within the preceding 90 days&#xD;
&#xD;
          -  Has known allergy to components of the test product&#xD;
&#xD;
          -  Use of anti-inflammatory steroid medications, anticoagulants, current/recent (3&#xD;
             months) history of anabolic steroid, corticosteroid or estrogen use, testosterone&#xD;
             replacement therapy (ingestion, injection, or transdermal), or any anabolic steroid&#xD;
&#xD;
          -  Has any concurrent medical or psychiatric condition that, in the opinion of the&#xD;
             Investigator, would compromise his/her ability to comply with the study requirements&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>April 6, 2022</last_update_submitted>
  <last_update_submitted_qc>April 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abdominal Pain</mesh_term>
  </condition_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/NCT04450979
org study id: AFCRO-063
nct id: NCT04450979
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This trial will investigate the potential of a bioactive peptide to reduce symptoms of
      digestive discomfort in a generally healthy elderly population. Participants will consume the
      bioactive peptide for 12 weeks and various measures indicating an improvement in health and
      well being will be taken throughout the trial. It is believed that consumption of the study
      product will reduce the severity of digestive discomfort, reduce chronic inflammation,
      improve blood glucose metabolism and improve physical performance.
Forty subjects aged between 65 and 75 with self-reported symptoms of digestive discomfort
      will be randomised. Subjects will be randomised to receive either the Bioactive peptide or
      placebo for a total of 12 weeks.

      Subjects will undergo an initial phone screen and will be asked questions regarding their age
      and their symptoms of digestive discomfort. Eligible subjects will be scheduled for a
      screening visit. The study will involve 5 visits over a 13 to 16 week period.

      At the screening visit (Visit 1) the inclusion and exclusion criteria will be reviewed and
      the overall details of the study will be explained and informed consent obtained. Vitals and
      Medical history, demographic data and concomitant medication will be recorded.

      Subjects will be asked questions relating to their digestive symptoms, including symptoms of
      abdominal pain, discomfort, bloating and flatulence. Subjects will complete the Digestive
      Symptom Frequency Questionnaire (DSFQ), the International Physical Activity Questionnaire
      (IPAQ) and the Mini-mental State Exam (MMSE) will be administered. The Fried Frailty score
      will be completed and the Short Physical Performance Battery (SPPB) test will be performed. A
      fasting blood sample (9mls) will be collected and haematology, biochemistry, glucose and
      blood lipids will be measured.

      Subjects will be provided with a stool collection kit and instructions for collecting and
      storing. Subjects will collect a stool sample at home, within 24 hours of their next visit
      and bring it to the clinic at their next visit.

      If the subject meets the eligibility criteria, they will be invited to participate in the
      study and will be given an appointment to return to the study site within 4 weeks for their
      baseline/week 0 visit.

      Subjects will attend visit 2 fasting. The inclusion and exclusion criteria will be reviewed
      and eligibility for study entry confirmed. An Oral Glucose Tolerance Test will be performed.
      Haematology, biochemistry and blood lipids will also be measured.

      A urine sample will be collected and also stored frozen for analysis of metabolites.

      Vitals, anthropometric measurements, concomitant medication and any adverse events will be
      recorded and The Short Physical Performance Battery (SPPB) test will be performed.

      Subjects will complete the Digestive Symptom Frequency Questionnaire and the hand-grip and
      chair-stand tests will be performed. A DEXA scan will be performed and muscle and fat mass
      recorded.

      Subjects will be randomized to receive the Bioactive peptide or placebo and receive a 4 week
      supply of product and instructions for dosing. Subjects will be provided with a stool
      collection kit and instructions for collecting and storing. Subjects will collect a stool
      sample at home, within 24 hours of their next visit and bring it to the clinic at their next
      visit.

      Subjects will return for visits at week 4, week 8 and week 12.

      A similar regimen will be followed for visits at week 4, week 8 and week 12.

      The site, investigator, protocol, informed consent form and any other pertinent documents for
      this study will be approved by: Cork Research Ethics Committee of the Cork Teaching
      Hospitals, Lancaster Hall, 6 Little Hanover Street, Cork.

      The investigator is responsible for ensuring that all source documents (i.e. study and/or
      medical records) are completed and maintained according to the study protocol, Good Clinical
      Practice (GCP) and are available at the site.

      LIST OF ABBREVIATIONS AND DEFINITION OF TERMS

      ANCOVA Analysis of co-variance AUC Area Under the Plasma Concentration BMI Body mass index BP
      Blood pressure CI Confidence interval CRF Case Report Form CRO Contract Research Organization
      EFSA European Food Safety Authority GCP Good Clinical Practice GMP Good Manufacturing
      Practice HbAIc Glycated haemoglobin (A1c) ICH International Conference on Harmonization INCI
      The International Nomenclature of Cosmetic Ingredients ITT Intent-to-treat kDa Kilodalton kg
      Kilogram L Liter MCH Mean corpuscular hemoglobin MCHC Mean corpuscular hemoglobin
      concentration MCV Mean corpuscular volume MCPs Marine collagen peptides MedDRA Medical
      Dictionary for Regulatory Activities mITT Modified intention-to-treat mL Milliliter mmHg
      Millimeter of mercury mmol/mol Millimoles per mole OGTT Oral glucose tolerance test PPP Per
      protocol population RDW Red cell distribution width SAE Serious adverse event SAP Statistical
      analysis plan VLDL Very low-density lipoprotein WHO World Health Organisation
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
measure: Digestive symptom frequency questionnaire
time frame: Baseline (week 0) and end of treatment (week 12)
description: The primary endpoint is the difference between the change experienced over 12 weeks in the active group versus the change in the placebo group using the digestive symptom frequency questionnaire (DSFQ) at baseline and end of treatment
measure: To determine the effect of supplementation of a Bioactive Peptide on muscle mass
time frame: Baseline (week 0) and week 12
description: Muscle mass, measured by dual-energy x-ray absorptiometry (DXA) at weeks 0 and 12
measure: To determine the effect of supplementation of a Bioactive Peptide on upper body muscle strength
time frame: Baseline (weeks 0) and week 4, week 8 and week 12
description: Upper body muscle strength, measured by the hand-grip test
measure: To determine the effect of supplementation of a Bioactive Peptide on lower body muscle strength
time frame: Baseline (weeks 0) and week 4, week 8 and week 12
description: Lower body muscle strength, measured by the chair stand test
measure: To determine the effect of supplementation of a Bioactive Peptide on physical performance
time frame: Baseline (weeks 0) and week 12
description: Short physical performance battery test score
measure: To determine the effect of supplementation of a Bioactive Peptide on blood glucose
time frame: Baseline (weeks 0) and week 12
description: Glucose as measured by the Oral Glucose Tolerance Test
measure: To determine the effect of supplementation of a Bioactive Peptide on blood markers of inflammation
time frame: Baseline (weeks 0) and week 4, week 8 and week 12
description: Inflammatory cytokines (IL6 & IL1R, CRP, TNF)
measure: To determine the effect of supplementation of a Bioactive Peptide on blood lipid
time frame: Baseline (weeks 0) and week 4, week 8 and week 12
description: Lipids (Total cholesterol, LDL, HDL, Triglycerides
arm group label: Bioactive hydrolysate
arm group type: Active Comparator
description: 20 g of hydrolysed rice protein
arm group label: Placebo
arm group type: Placebo Comparator
description: 20 g micro crystalline cellulose
intervention type: Dietary Supplement
intervention name: Bioactive hydrolysate
description: Participants given a bioactive vegetable hydrolysate to take one dose each morning and one dose each evening for the duration of the study.
arm group label: Bioactive hydrolysate
arm group label: Placebo
criteria: 
gender: All
minimum age: 65 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Abdominal Pain