<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/NCT01733563</url>
  </required_header>
  <id_info>
    <org_study_id>SSB-Effects on metabolism</org_study_id>
    <nct_id>NCT01733563</nct_id>
  </id_info>
  <brief_title>Sugar Sweetened Beverages (SSB)- Effects on Metabolism</brief_title>
  <official_title>Effects of Carbohydrate Containing Diets on Lipid Metabolism &amp; Fatty Acid Oxidation in Healthy Young Men - a Randomized, Double-Blinded Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>SNF Swiss National Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Lausanne</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to investigate the impact of sugar sweetened beverages on the&#xD;
      fat metabolism of healthy young men. It is well known that consumption of beverages sweetened&#xD;
      with fructose is associated with different health risks such as type 2 diabetes. The present&#xD;
      study has been designed to dissect differences in the metabolic pathways of fructose and&#xD;
      glucose, but also metabolic adaptations during fructose, glucose and sucrose diets. During a&#xD;
      period of seven weeks subjects will consume either fructose, glucose or sucrose sweetened&#xD;
      beverages or continue their usual drinking habits. During these seven weeks there will be&#xD;
      different metabolic investigations using stable isotope tracers. First, the rate of lipolysis&#xD;
      and beta-oxidation will be determined. Second, the rates of fatty acid synthesis will be&#xD;
      measured. During all examinations there will also be substrate- and energy-utilization&#xD;
      measurements by indirect calorimetry, blood analysis and morphometric measurements. Based on&#xD;
      the literature main hypotheses are: Fructose enhances de novo lipogenesis postprandially and&#xD;
      also in the fasting state significantly more than glucose by enhanced expression of lipogenic&#xD;
      enzymes. Fructose decreases beta oxidation via downregulation of oxidative enzymes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 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>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Lipogenesis</measure>
    <time_frame>After total 6 weeks dietary intervention</time_frame>
    <description>Measurement of lipogenesis is based on i. v. administration of stable isotope labelled acetate (1,2-13C-acetate). 13C incorporation into palmitate is quantified by mass-spectrometry. 13C incorporation correlates to the rate of fatty acid synthesis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lipolysis</measure>
    <time_frame>After total 6 weeks dietary intervention</time_frame>
    <description>Measurements using stable isotopes</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Waist/Hip Ratio</measure>
    <time_frame>After total 6 weeks dietary intervention</time_frame>
    <description>Measurement waist/hip ratio using a nonstretchable band</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Metabolism</condition>
  <arm_group>
    <arm_group_label>fructose sweetened beverage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Soft drink consumption:&#xD;
Subjects have to drink a fructose sweetened beverage (3x 200ml per day, 13.3g fructose/100ml) during 7 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>glucose sweetened beverage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Soft drink consumption:&#xD;
Subjects have to drink a glucose sweetened beverage (3x 200ml per day, 13.3g glucose/100ml) during 7 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sucrose sweetened beverage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Soft drink consumption:&#xD;
Subjects have to drink a sucrose sweetened beverage (3x 200ml per day, 13.3g sucrose/100ml) during 7 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No change of eating habits</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>No Soft drink consumption (no soft drink diet):&#xD;
Subjects do not change their eating habits during 7 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Soft drink consumption</intervention_name>
    <arm_group_label>No change of eating habits</arm_group_label>
    <arm_group_label>fructose sweetened beverage</arm_group_label>
    <arm_group_label>glucose sweetened beverage</arm_group_label>
    <arm_group_label>sucrose sweetened beverage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Healthy male volunteers aged 18-30&#xD;
&#xD;
          -  BMI between 19-24 kg/m2&#xD;
&#xD;
          -  Non-smoker&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Acute or chronic infections, malignant disease, renal, hepatic (more than two-fold&#xD;
             increased transaminases), pulmonary, neurological (epilepsy) or psychiatric diseases,&#xD;
             manifested atherosclerosis, or any other disease precluding participation in the&#xD;
             study.&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Known alcohol, substance or drug abuse, concomitant medication&#xD;
&#xD;
          -  More than three hours of physical exercise per week&#xD;
&#xD;
          -  Consumption of more than 2 times 3 dl SSB daily&#xD;
&#xD;
          -  Subjects likely to fail to comply with the study protocol&#xD;
&#xD;
          -  Subjects who do not give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philipp Gerber, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Zurich, Endocrinology and Diabetology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Zurich, Endocrinology and Diabetology</name>
      <address>
        <city>Zurich</city>
        <state>ZH</state>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>November 9, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>May 10, 2016</last_update_submitted>
  <last_update_submitted_qc>May 10, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>sugar sweetened beverages</keyword>
  <keyword>fructose</keyword>
  <keyword>lipogenesis</keyword>
  <keyword>beta-oxidation</keyword>
  <!-- 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/NCT01733563
org study id: SSB-Effects on metabolism
nct id: NCT01733563
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The objective of this study is to investigate the impact of sugar sweetened beverages on the
      fat metabolism of healthy young men. It is well known that consumption of beverages sweetened
      with fructose is associated with different health risks such as type 2 diabetes. The present
      study has been designed to dissect differences in the metabolic pathways of fructose and
      glucose, but also metabolic adaptations during fructose, glucose and sucrose diets. During a
      period of seven weeks subjects will consume either fructose, glucose or sucrose sweetened
      beverages or continue their usual drinking habits. During these seven weeks there will be
      different metabolic investigations using stable isotope tracers. First, the rate of lipolysis
      and beta-oxidation will be determined. Second, the rates of fatty acid synthesis will be
      measured. During all examinations there will also be substrate- and energy-utilization
      measurements by indirect calorimetry, blood analysis and morphometric measurements. Based on
      the literature main hypotheses are: Fructose enhances de novo lipogenesis postprandially and
      also in the fasting state significantly more than glucose by enhanced expression of lipogenic
      enzymes. Fructose decreases beta oxidation via downregulation of oxidative enzymes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Lipogenesis
time frame: After total 6 weeks dietary intervention
description: Measurement of lipogenesis is based on i. v. administration of stable isotope labelled acetate (1,2-13C-acetate). 13C incorporation into palmitate is quantified by mass-spectrometry. 13C incorporation correlates to the rate of fatty acid synthesis.
measure: Lipolysis
time frame: After total 6 weeks dietary intervention
description: Measurements using stable isotopes
measure: Waist/Hip Ratio
time frame: After total 6 weeks dietary intervention
description: Measurement waist/hip ratio using a nonstretchable band
arm group label: fructose sweetened beverage
arm group type: Experimental
description: Soft drink consumption:
Subjects have to drink a fructose sweetened beverage (3x 200ml per day, 13.3g fructose/100ml) during 7 weeks
arm group label: glucose sweetened beverage
arm group type: Experimental
description: Soft drink consumption:
Subjects have to drink a glucose sweetened beverage (3x 200ml per day, 13.3g glucose/100ml) during 7 weeks
arm group label: sucrose sweetened beverage
arm group type: Experimental
description: Soft drink consumption:
Subjects have to drink a sucrose sweetened beverage (3x 200ml per day, 13.3g sucrose/100ml) during 7 weeks
arm group label: No change of eating habits
arm group type: Experimental
description: No Soft drink consumption (no soft drink diet):
Subjects do not change their eating habits during 7 weeks
intervention type: Procedure
intervention name: Soft drink consumption
arm group label: No change of eating habits
arm group label: fructose sweetened beverage
arm group label: glucose sweetened beverage
arm group label: sucrose sweetened beverage
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: No
last name: Philipp Gerber, MD
role: Principal Investigator
affiliation: University Hospital Zurich, Endocrinology and Diabetology
facility: 
country: Switzerland
responsible party type: Sponsor