<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/NCT03267901</url>
  </required_header>
  <id_info>
    <org_study_id>CWC-2016-MetS</org_study_id>
    <nct_id>NCT03267901</nct_id>
  </id_info>
  <brief_title>Effects of Daily Walnut Intake Among the Subjects With Metabolic Syndrome</brief_title>
  <official_title>Effects of Daily Walnut Intake Among the Subjects With Metabolic Syndrome in South Korea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ICAN Nutrition Education and Research</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>California Walnut Commission</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>ICAN Nutrition Education and Research</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>
      Investigators planed to conduct a randomized, controlled, crossover trial to examine the&#xD;
      effects of daily walnuts intake among Korean subjects with metabolic syndrome. Primary&#xD;
      objective of this study was to investigate the effects of daily walnut intake on changes of&#xD;
      metabolic syndrome indices in Koreans with metabolic syndrome age over 30 years old. This&#xD;
      study was consisted of four periods: run-in, first intervention, wash-out, and second&#xD;
      intervention phases. As 16 weeks of first intervention period began after the run-in phase,&#xD;
      the subjects were randomly assigned into one of two groups: walnut group and control group.&#xD;
      Participants in walnut group consumed 45 grams of walnuts on a daily basis and participants&#xD;
      in control group were provided iso-caloric white bread for first 16 weeks. After the first&#xD;
      intervention and wash-out period (6 weeks), second intervention which is crossover of first&#xD;
      intervention was started during the next 16 weeks. Anthropometric measurements and&#xD;
      biochemical analyses were done at the beginning and the end of each intervention (0, 16, 22,&#xD;
      and 38 weeks of trial). Habitual diet was randomly observed using 3-day diet record once&#xD;
      during each phase.&#xD;
&#xD;
      Investigators expected to evaluate 1)effects of walnut ingestion on reverting metabolic&#xD;
      syndrome to normal status especially by reducing waist circumference and improving serum&#xD;
      levels of triglyceride and high-density lipoprotein, 2)beneficial effects of daily walnut&#xD;
      consumption on changes of body composition in the subjects with metabolic syndrome, and&#xD;
      3)regulatory effects of daily walnut intake on inflammatory markers and diabetic markers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2015</start_date>
  <completion_date type="Actual">July 30, 2017</completion_date>
  <primary_completion_date type="Actual">July 30, 2017</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>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>changes of waist circumference</measure>
    <time_frame>after 16 weeks of daily walnut consumption</time_frame>
    <description>Waist circumferences (cm) were obtained at the midpoint between the lowest rib and the iliac crest and rounded to the nearest 0.1 cm after inhalation and exhalation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>changes of blood triglyceride level</measure>
    <time_frame>after 16 weeks of daily walnut consumption</time_frame>
    <description>Serum triglycerides (mg/dL) levels were measured by an enzymatic-colorimetric method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>changes of blood high-density lipoprotein cholesterol levels</measure>
    <time_frame>after 16 weeks of daily walnut consumption</time_frame>
    <description>High density lipoprotein cholesterol (mg/dL) levels were determined by a homogeneous enzymatic-colorimetric method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>changes of blood pressure</measure>
    <time_frame>after 16 weeks of daily walnut consumption</time_frame>
    <description>Blood pressure (mmHg) was measured on the right arm using an up-load blood pressure monitor with participants in a comfortably seated position after at least a 5-minute rest.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>changes of blood glucose level</measure>
    <time_frame>after 16 weeks of daily walnut consumption</time_frame>
    <description>Blood glucose levels (mg/dL) were measured using blood glucose monitor and test stripts from the finger tip.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes of total cholesterol level</measure>
    <time_frame>after 16 weeks of daily walnut consumption</time_frame>
    <description>Serum total cholesterol levels (ml/dL) were measured by an enzymatic-colorimetric method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes of serum apolipoprotein B level</measure>
    <time_frame>after 16 weeks of daily walnut consumption</time_frame>
    <description>Serum apolipoprotein B (ml/dL) was measured using a turbidimetric immunoassay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes of serum adiponectin level</measure>
    <time_frame>after 16 weeks of daily walnut consumption</time_frame>
    <description>Blood adiponectin (ug/mL) levels were measured using ELISA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes of serum leptin level</measure>
    <time_frame>after 16 weeks of daily walnut consumption</time_frame>
    <description>Blood leptin (ug/mL) levels were measured using ELISA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes of serum insulin level</measure>
    <time_frame>after 16 weeks of daily walnut consumption</time_frame>
    <description>Serum insulin (μU/mL) was measured with a commercially available kit, the ultrasensitive insulin ELISA kit using an Epoch microplate spectrophotometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes of low-density lipoprotein cholesterol level</measure>
    <time_frame>after 16 weeks of daily walnut consumption</time_frame>
    <description>Low-density lipoprotein cholesterol levels (ml/dL) were determined by a homogeneous enzymatic-colorimetric method.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">119</enrollment>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>Walnut-Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control-Walnut</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>food</intervention_name>
    <description>45 g of walnut / iso-caloric white bread</description>
    <arm_group_label>Control-Walnut</arm_group_label>
    <arm_group_label>Walnut-Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: at least three out of five metabolic syndrome components&#xD;
&#xD;
          -  waist circumference (WC) &gt;90 cm for men and &gt;80 cm for women&#xD;
&#xD;
          -  hypertension (DBP ≥85 and &lt;110 mm Hg)&#xD;
&#xD;
          -  hyperglycemia (≥100 mg/dL)&#xD;
&#xD;
          -  elevated plasma TG concentrations (≥150 mg/dL)&#xD;
&#xD;
          -  decreased plasma HDL-C concentrations (&lt;40 mg/dL for men and &lt;50 mg/dL for women)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  the presence of morbid obesity (BMI ≥40)&#xD;
&#xD;
          -  the use of any medication for the control of blood pressure, glucose, or lipid&#xD;
             metabolism&#xD;
&#xD;
          -  a medical history of hypocaloric diet consumption within the past year&#xD;
&#xD;
          -  gastrointestinal tract disorders&#xD;
&#xD;
          -  post-menopausal women&#xD;
&#xD;
          -  smokers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>ICAN Nutrition Education and Research</name>
      <address>
        <city>Seoul</city>
        <zip>07327</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>August 28, 2017</last_update_submitted>
  <last_update_submitted_qc>August 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2017</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>Metabolic Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03267901
org study id: CWC-2016-MetS
nct id: NCT03267901
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Investigators planed to conduct a randomized, controlled, crossover trial to examine the
      effects of daily walnuts intake among Korean subjects with metabolic syndrome. Primary
      objective of this study was to investigate the effects of daily walnut intake on changes of
      metabolic syndrome indices in Koreans with metabolic syndrome age over 30 years old. This
      study was consisted of four periods: run-in, first intervention, wash-out, and second
      intervention phases. As 16 weeks of first intervention period began after the run-in phase,
      the subjects were randomly assigned into one of two groups: walnut group and control group.
      Participants in walnut group consumed 45 grams of walnuts on a daily basis and participants
      in control group were provided iso-caloric white bread for first 16 weeks. After the first
      intervention and wash-out period (6 weeks), second intervention which is crossover of first
      intervention was started during the next 16 weeks. Anthropometric measurements and
      biochemical analyses were done at the beginning and the end of each intervention (0, 16, 22,
      and 38 weeks of trial). Habitual diet was randomly observed using 3-day diet record once
      during each phase.

      Investigators expected to evaluate 1)effects of walnut ingestion on reverting metabolic
      syndrome to normal status especially by reducing waist circumference and improving serum
      levels of triglyceride and high-density lipoprotein, 2)beneficial effects of daily walnut
      consumption on changes of body composition in the subjects with metabolic syndrome, and
      3)regulatory effects of daily walnut intake on inflammatory markers and diabetic markers.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: changes of waist circumference
time frame: after 16 weeks of daily walnut consumption
description: Waist circumferences (cm) were obtained at the midpoint between the lowest rib and the iliac crest and rounded to the nearest 0.1 cm after inhalation and exhalation.
measure: changes of blood triglyceride level
time frame: after 16 weeks of daily walnut consumption
description: Serum triglycerides (mg/dL) levels were measured by an enzymatic-colorimetric method.
measure: changes of blood high-density lipoprotein cholesterol levels
time frame: after 16 weeks of daily walnut consumption
description: High density lipoprotein cholesterol (mg/dL) levels were determined by a homogeneous enzymatic-colorimetric method.
measure: changes of blood pressure
time frame: after 16 weeks of daily walnut consumption
description: Blood pressure (mmHg) was measured on the right arm using an up-load blood pressure monitor with participants in a comfortably seated position after at least a 5-minute rest.
measure: changes of blood glucose level
time frame: after 16 weeks of daily walnut consumption
description: Blood glucose levels (mg/dL) were measured using blood glucose monitor and test stripts from the finger tip.
measure: changes of total cholesterol level
time frame: after 16 weeks of daily walnut consumption
description: Serum total cholesterol levels (ml/dL) were measured by an enzymatic-colorimetric method.
measure: changes of serum apolipoprotein B level
time frame: after 16 weeks of daily walnut consumption
description: Serum apolipoprotein B (ml/dL) was measured using a turbidimetric immunoassay.
measure: changes of serum adiponectin level
time frame: after 16 weeks of daily walnut consumption
description: Blood adiponectin (ug/mL) levels were measured using ELISA.
measure: changes of serum leptin level
time frame: after 16 weeks of daily walnut consumption
description: Blood leptin (ug/mL) levels were measured using ELISA.
measure: changes of serum insulin level
time frame: after 16 weeks of daily walnut consumption
description: Serum insulin (μU/mL) was measured with a commercially available kit, the ultrasensitive insulin ELISA kit using an Epoch microplate spectrophotometer.
measure: changes of low-density lipoprotein cholesterol level
time frame: after 16 weeks of daily walnut consumption
description: Low-density lipoprotein cholesterol levels (ml/dL) were determined by a homogeneous enzymatic-colorimetric method.
arm group label: Walnut-Control
arm group type: Experimental
arm group label: Control-Walnut
arm group type: Experimental
intervention type: Other
intervention name: food
description: 45 g of walnut / iso-caloric white bread
arm group label: Control-Walnut
arm group label: Walnut-Control
criteria: 
gender: All
minimum age: 30 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Metabolic Syndrome
mesh term: Syndrome
sharing ipd: Undecided