<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/NCT02247596</url>
  </required_header>
  <id_info>
    <org_study_id>2009/00454</org_study_id>
    <nct_id>NCT02247596</nct_id>
  </id_info>
  <brief_title>Effects of High-Dose Resveratrol in Non-Diabetic Obese Males</brief_title>
  <official_title>Effects of High-Dose Resveratrol on Resting Energy Expenditure and HOMA in Non-Diabetic Obese Males</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Khoo Teck Puat Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Medical Research Council (NMRC), Singapore</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Khoo Teck Puat Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim of our study was to examine the effects of two weeks of oral resveratrol on&#xD;
      resting energy expenditure and insulin sensitivity in non-diabetic obese male subjects.&#xD;
      Secondary variables included plasma lipid subfraction, blood pressure and glycated hemoglobin&#xD;
      (HbA1c).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients were recruited between July 2009 and July 2012 from a single hospital in Singapore.&#xD;
      Eligible patients were Chinese males, aged between 21 and 55 years old, with a body mass&#xD;
      index (BMI) of 30 kg/m2 or more and venous glucose of &lt;7.0 and &lt;11.1 mmol/L at 0 and 120&#xD;
      minutes respectively on oral glucose tolerance testing (OGTT) following a 12-hour fast. They&#xD;
      must be willing to abstain from embarking on an exercise regime or ingesting large quantities&#xD;
      of resveratrol-containing foods including alcohol during the study period.&#xD;
&#xD;
      The study was a randomized, double-blind, parallel group trial consisting of a screening&#xD;
      visit, a two-week treatment period and a post-treatment visit.&#xD;
&#xD;
      Randomization was centrally performed during treatment assignment with a 2-digit reference&#xD;
      code placed in sealed opaque envelopes maintained by the person responsible for the&#xD;
      preparation of the intervention drug and placebo. Trans-resveratrol extract from Polygonum&#xD;
      Cuspidatum (Mega Resveratrol, Danbury, USA) was used in the trial. The placebo was not&#xD;
      distinguishable by color, form, or taste from the active drug. The randomization code was&#xD;
      unblinded only after all predefined data were recorded.&#xD;
&#xD;
      Subjects were given 1g three times a day of either resveratrol or placebo for two weeks and&#xD;
      instructed to abstain from foods with high resveratrol content during the entire duration of&#xD;
      the trial. Compliance was determined by pill counting at the end of the trial period.&#xD;
      Subjects in both arms were not allowed to commence on an exercise regimen or supplements&#xD;
      during the study period. Subjects who dropped out of the trial would not be replaced. All&#xD;
      variables were measured at baseline and at the end of the treatment period.&#xD;
&#xD;
      RMR was measured by indirect calorimetry using a breath-by-breath metabolic gas analyser via&#xD;
      the face-mask method.&#xD;
&#xD;
      The investigators estimated that a sample size of 18 patients per group (Total N = 36) was&#xD;
      needed to provide 80% power and two-sided 5% to detect a difference in a Cohen's effect size&#xD;
      of 1.0 between the two groups.&#xD;
&#xD;
      All analyses were performed using SPSS 21.0 (IBM) with statistical significance set at p &lt;&#xD;
      0.05 and with the percentage change from baseline as the unit of analysis. All data were&#xD;
      analyzed according to the intention-to-treat principle. MANOVA was performed to compare the&#xD;
      intervention and placebo groups for the unadjusted and adjusted p-values on the study&#xD;
      variables of interest. Normal distribution was verified with the Kolmogorov-Smirnov test and&#xD;
      data were presented as mean ± standard deviation (SD).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2009</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in Resting Energy Expenditure via indirect calorimetry at 2 weeks</measure>
    <time_frame>2 weeks (pre and post intervention)</time_frame>
    <description>Measured in Kcal/day using a metabolic cart</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in insulin resistance via Homeostasis Model Assessment (HOMA) 2 calculator at 2 weeks</measure>
    <time_frame>2 weeks (pre and post intervention)</time_frame>
    <description>Beta cell function, B (%),Insulin sensitivity, S (%), Insulin resistance, IR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in lipid subfractions at 2 weeks</measure>
    <time_frame>2 weeks (pre and post intervention)</time_frame>
    <description>LDL, HDL and triglycerides in mmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Blood pressure at 2 weeks</measure>
    <time_frame>2 weeks (pre and post intervention)</time_frame>
    <description>Systolic and diastolic blood pressure in mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Glycated hemoglobin at 2 weeks</measure>
    <time_frame>2 weeks (pre and post intervention)</time_frame>
    <description>HbA1c in %</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Obesity</condition>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Sugar pill 1g tds for 2 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resveratrol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Trans-resveratrol extract from Polygonum Cuspidatum 1g three times a day for 2 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Resveratrol</intervention_name>
    <description>1g tds 2 weeks</description>
    <arm_group_label>Resveratrol</arm_group_label>
    <other_name>Mega Resveratrol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Sugar pill 1g tds for 2 weeks</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability to give informed consent&#xD;
&#xD;
          -  Obese Chinese Male&#xD;
&#xD;
          -  Age 21 to 55 yrs old&#xD;
&#xD;
          -  No diabetes mellitus&#xD;
&#xD;
          -  BMI of 30 kg/m2 or more during screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unwilling to abstain from ingesting large quantities of resveratrol-containing foods&#xD;
             (eg. red wine, nuts)&#xD;
&#xD;
          -  Cancer diagnosis that is currently under treatment, is clinically detectable, or that&#xD;
             has been treated within the past 5 years&#xD;
&#xD;
          -  Terminal disease or on palliative care&#xD;
&#xD;
          -  Current excessive alcohol intake (&gt;21 units per week for men; 14 units per week for&#xD;
             women)&#xD;
&#xD;
          -  Known diabetes mellitus&#xD;
&#xD;
          -  Past history of unexplained hypoglycemia&#xD;
&#xD;
          -  Past or current history of strokes&#xD;
&#xD;
          -  History of any grape allergy&#xD;
&#xD;
          -  On alternative or traditional medications&#xD;
&#xD;
          -  Treated with another investigational drug within last 6 months&#xD;
&#xD;
          -  Poorly controlled hypertension (SBP &gt;/= 160 or DBP &gt;/= 100) within last one month&#xD;
&#xD;
          -  ALT and/or AST &gt; 1.5 times above upper limit of normal within last 6 months&#xD;
&#xD;
          -  GFR &lt; 50 ml/min/1.73m2 (MDRD equation) within last 6 months&#xD;
&#xD;
          -  Staff of Department of Medicine, Khoo Teck Puat Hospital&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kian Peng Goh</last_name>
    <role>Principal Investigator</role>
    <affiliation>Khoo Teck Puat Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Khoo Teck Puat Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>768828</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>September 19, 2014</last_update_submitted>
  <last_update_submitted_qc>September 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Khoo Teck Puat Hospital</investigator_affiliation>
    <investigator_full_name>Goh Kian Peng</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <keyword>Resveratrol</keyword>
  <keyword>obesity</keyword>
  <keyword>insulin resistance</keyword>
  <keyword>energy expenditure</keyword>
  <keyword>diabetes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Resveratrol</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/NCT02247596
org study id: 2009/00454
nct id: NCT02247596
lead sponsor: 
collaborator: 
has dmc: Yes
The primary aim of our study was to examine the effects of two weeks of oral resveratrol on
      resting energy expenditure and insulin sensitivity in non-diabetic obese male subjects.
      Secondary variables included plasma lipid subfraction, blood pressure and glycated hemoglobin
      (HbA1c).
Patients were recruited between July 2009 and July 2012 from a single hospital in Singapore.
      Eligible patients were Chinese males, aged between 21 and 55 years old, with a body mass
      index (BMI) of 30 kg/m2 or more and venous glucose of <7.0 and <11.1 mmol/L at 0 and 120
      minutes respectively on oral glucose tolerance testing (OGTT) following a 12-hour fast. They
      must be willing to abstain from embarking on an exercise regime or ingesting large quantities
      of resveratrol-containing foods including alcohol during the study period.

      The study was a randomized, double-blind, parallel group trial consisting of a screening
      visit, a two-week treatment period and a post-treatment visit.

      Randomization was centrally performed during treatment assignment with a 2-digit reference
      code placed in sealed opaque envelopes maintained by the person responsible for the
      preparation of the intervention drug and placebo. Trans-resveratrol extract from Polygonum
      Cuspidatum (Mega Resveratrol, Danbury, USA) was used in the trial. The placebo was not
      distinguishable by color, form, or taste from the active drug. The randomization code was
      unblinded only after all predefined data were recorded.

      Subjects were given 1g three times a day of either resveratrol or placebo for two weeks and
      instructed to abstain from foods with high resveratrol content during the entire duration of
      the trial. Compliance was determined by pill counting at the end of the trial period.
      Subjects in both arms were not allowed to commence on an exercise regimen or supplements
      during the study period. Subjects who dropped out of the trial would not be replaced. All
      variables were measured at baseline and at the end of the treatment period.

      RMR was measured by indirect calorimetry using a breath-by-breath metabolic gas analyser via
      the face-mask method.

      The investigators estimated that a sample size of 18 patients per group (Total N = 36) was
      needed to provide 80% power and two-sided 5% to detect a difference in a Cohen's effect size
      of 1.0 between the two groups.

      All analyses were performed using SPSS 21.0 (IBM) with statistical significance set at p <
      0.05 and with the percentage change from baseline as the unit of analysis. All data were
      analyzed according to the intention-to-treat principle. MANOVA was performed to compare the
      intervention and placebo groups for the unadjusted and adjusted p-values on the study
      variables of interest. Normal distribution was verified with the Kolmogorov-Smirnov test and
      data were presented as mean ± standard deviation (SD).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change from baseline in Resting Energy Expenditure via indirect calorimetry at 2 weeks
time frame: 2 weeks (pre and post intervention)
description: Measured in Kcal/day using a metabolic cart
measure: Change from baseline in insulin resistance via Homeostasis Model Assessment (HOMA) 2 calculator at 2 weeks
time frame: 2 weeks (pre and post intervention)
description: Beta cell function, B (%),Insulin sensitivity, S (%), Insulin resistance, IR
measure: Change from baseline in lipid subfractions at 2 weeks
time frame: 2 weeks (pre and post intervention)
description: LDL, HDL and triglycerides in mmol/L
measure: Change from baseline in Blood pressure at 2 weeks
time frame: 2 weeks (pre and post intervention)
description: Systolic and diastolic blood pressure in mmHg
measure: Change from baseline in Glycated hemoglobin at 2 weeks
time frame: 2 weeks (pre and post intervention)
description: HbA1c in %
arm group label: Placebo
arm group type: Placebo Comparator
description: Sugar pill 1g tds for 2 weeks
arm group label: Resveratrol
arm group type: Experimental
description: Trans-resveratrol extract from Polygonum Cuspidatum 1g three times a day for 2 weeks
intervention type: Drug
intervention name: Resveratrol
description: 1g tds 2 weeks
arm group label: Resveratrol
other name: Mega Resveratrol
intervention type: Drug
intervention name: Placebo
description: Sugar pill 1g tds for 2 weeks
arm group label: Placebo
criteria: 
gender: Male
minimum age: 21 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kian Peng Goh
role: Principal Investigator
affiliation: Khoo Teck Puat Hospital
facility: 
country: Singapore
responsible party type: Principal Investigator
investigator affiliation: Khoo Teck Puat Hospital
investigator full name: Goh Kian Peng
investigator title: PI
mesh term: Obesity
mesh term: Resveratrol