<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/NCT04486105</url>
  </required_header>
  <id_info>
    <org_study_id>15738</org_study_id>
    <nct_id>NCT04486105</nct_id>
  </id_info>
  <brief_title>Chronic Sucrose Intake, Markers of Health and Biomarker Identification</brief_title>
  <official_title>Investigation of Sucrose-induced Metabolic Adaptation and Biomarkers of Chronic Sucrose Intake in Humans Using a Multi-omic Approach</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northumbria University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northumbria 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>
      With free sugar intake proving to be of a concern within the general public, discovery and&#xD;
      validation of a new biomarker will allow for more consistent measurement of sucrose intake.&#xD;
      Furthermore, using a multi-omic approach the investigators will identify metabolic&#xD;
      perturbations to the metabolome and proteome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Excessive free sugar intake is of concern within the general public, as intakes have been&#xD;
      associated with weight gain and cardiovascular disease. Average intakes are over double that&#xD;
      of the 5% of total energy intake that is recommended by the Science Advisory Committee on&#xD;
      Nutrition, but intakes are calculated from observational measures that lack sensitivity and&#xD;
      discovery and validation of a new biomarker from biological fluids may allow for more&#xD;
      specific measurement and a better understanding of intake:disease relationships. Furthermore,&#xD;
      understanding the biochemistry of sucrose intake will allow the identification of damage&#xD;
      occurrence and alternative metabolic pathways, as well as novel protein damage that occur&#xD;
      with chronic sucrose exposure.&#xD;
&#xD;
      This study aims to identify a biomarker of chronic sucrose consumption using metabolite&#xD;
      profiling technology. The study will be composed of a randomised controlled intervention&#xD;
      trial, in which participants will be required to consume an amount of sucrose (0-120g/d)&#xD;
      every day for 7 days and provide biofluid samples (urine and blood) before the initiation,&#xD;
      during and following the intervention; that will undergo metabolic analysis. Furthermore,&#xD;
      participants will have their anthropometrics and dietary intake monitored throughout the&#xD;
      study. The biomarker will also be validated against the dietary information and correlated&#xD;
      with indices of health and sucrose-induced damage. The investigators will also monitor the&#xD;
      feasibility and acceptability of chronic sucrose intake during the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Anticipated">February 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2021</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>
    <intervention_model_description>RCT</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>change in blood pressure following one week intervention</time_frame>
    <description>Measurement of systolic and diastolic blood pressure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Metabolome</measure>
    <time_frame>change in the urinary metabolome following one week intervention</time_frame>
    <description>Metabolite profiling of urine samples, obtaining a profile of approximately 5000 metabolite intensities in urine</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body composition</measure>
    <time_frame>change in body mass index following one week intervention</time_frame>
    <description>measurement of body mass index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body composition</measure>
    <time_frame>change in percentage body fat following one week intervention</time_frame>
    <description>measurement of percentage body fat</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>food diary analysis</measure>
    <time_frame>change in dietary intake following the week intervention</time_frame>
    <description>measurement of energy, macro and micronutrient intakes from 3-day food diaries</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Dietary Exposure</condition>
  <condition>Metabolic Disturbance</condition>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>vehicle only for one week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>40g sucrose ingestion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>40g sucrose treatment on top of habitual diet for one week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>80g sucrose ingestion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>80g sucrose treatment on top of habitual diet for one week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>120g sucrose ingestion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>120g sucrose treatment on top of habitual diet for one week</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>sucrose</intervention_name>
    <description>pure sucrose in water in addition to habitual diet</description>
    <arm_group_label>120g sucrose ingestion</arm_group_label>
    <arm_group_label>40g sucrose ingestion</arm_group_label>
    <arm_group_label>80g sucrose ingestion</arm_group_label>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 19-64, healthy diagnosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  gastrointestinal issues, doesn't consume sugar&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John Lodge, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northumbria University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northumberland Building</name>
      <address>
        <city>Newcastle Upon Tyne</city>
        <zip>NE1 7ST</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northumbria University</investigator_affiliation>
    <investigator_full_name>John Lodge</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <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/NCT04486105
org study id: 15738
nct id: NCT04486105
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
With free sugar intake proving to be of a concern within the general public, discovery and
      validation of a new biomarker will allow for more consistent measurement of sucrose intake.
      Furthermore, using a multi-omic approach the investigators will identify metabolic
      perturbations to the metabolome and proteome.
Excessive free sugar intake is of concern within the general public, as intakes have been
      associated with weight gain and cardiovascular disease. Average intakes are over double that
      of the 5% of total energy intake that is recommended by the Science Advisory Committee on
      Nutrition, but intakes are calculated from observational measures that lack sensitivity and
      discovery and validation of a new biomarker from biological fluids may allow for more
      specific measurement and a better understanding of intake:disease relationships. Furthermore,
      understanding the biochemistry of sucrose intake will allow the identification of damage
      occurrence and alternative metabolic pathways, as well as novel protein damage that occur
      with chronic sucrose exposure.

      This study aims to identify a biomarker of chronic sucrose consumption using metabolite
      profiling technology. The study will be composed of a randomised controlled intervention
      trial, in which participants will be required to consume an amount of sucrose (0-120g/d)
      every day for 7 days and provide biofluid samples (urine and blood) before the initiation,
      during and following the intervention; that will undergo metabolic analysis. Furthermore,
      participants will have their anthropometrics and dietary intake monitored throughout the
      study. The biomarker will also be validated against the dietary information and correlated
      with indices of health and sucrose-induced damage. The investigators will also monitor the
      feasibility and acceptability of chronic sucrose intake during the intervention.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: RCT
primary purpose: Basic Science
masking: Single (Participant)
measure: Blood pressure
time frame: change in blood pressure following one week intervention
description: Measurement of systolic and diastolic blood pressure
measure: Metabolome
time frame: change in the urinary metabolome following one week intervention
description: Metabolite profiling of urine samples, obtaining a profile of approximately 5000 metabolite intensities in urine
measure: Body composition
time frame: change in body mass index following one week intervention
description: measurement of body mass index
measure: Body composition
time frame: change in percentage body fat following one week intervention
description: measurement of percentage body fat
measure: food diary analysis
time frame: change in dietary intake following the week intervention
description: measurement of energy, macro and micronutrient intakes from 3-day food diaries
arm group label: control
arm group type: Placebo Comparator
description: vehicle only for one week
arm group label: 40g sucrose ingestion
arm group type: Experimental
description: 40g sucrose treatment on top of habitual diet for one week
arm group label: 80g sucrose ingestion
arm group type: Experimental
description: 80g sucrose treatment on top of habitual diet for one week
arm group label: 120g sucrose ingestion
arm group type: Experimental
description: 120g sucrose treatment on top of habitual diet for one week
intervention type: Dietary Supplement
intervention name: sucrose
description: pure sucrose in water in addition to habitual diet
arm group label: 120g sucrose ingestion
arm group label: 40g sucrose ingestion
arm group label: 80g sucrose ingestion
arm group label: control
criteria: 
gender: All
minimum age: 19 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: John Lodge, PhD
role: Principal Investigator
affiliation: Northumbria University
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Northumbria University
investigator full name: John Lodge
investigator title: Associate Professor
sharing ipd: No