<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/NCT03251014</url>
  </required_header>
  <id_info>
    <org_study_id>06-01-04-SF2310</org_study_id>
    <secondary_id>NMRR-16-2693-32300.</secondary_id>
    <secondary_id>FPSK(FR16)P005</secondary_id>
    <nct_id>NCT03251014</nct_id>
  </id_info>
  <brief_title>Thrombotic Effects of Yellowstripe Scad</brief_title>
  <official_title>The Thrombotic Effects of Yellowstripe Scad (YSS) Compared to Salmon Among Healthy Overweight Subjects: A Randomized Cross Over Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universiti Putra Malaysia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Science, Technology and Innovation (MOSTI) Malaysia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universiti Putra Malaysia</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>
      The study aimed to determine the thrombotic effects of YSS compared with salmon among healthy&#xD;
      overweight subjects. It hypothesized that YSS may result significant, favorable thrombotic&#xD;
      effects and the effects may be similar with salmon.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The project was a randomized, two-period, crossover trial with 8-week treatment periods and&#xD;
      8-week washout period. A total of 50 healthy overweight adults were recruited among staff and&#xD;
      students in UPM. All the subjects were randomized into two groups. Each group was served with&#xD;
      either cooked YSS (~265 g/ day) or salmon (~246 g/day) thrice per week. Blood and urine&#xD;
      samples were collected for laboratory assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">May 9, 2017</completion_date>
  <primary_completion_date type="Actual">May 9, 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in hemostatic status assessed by immunoassay method</measure>
    <time_frame>8 weeks</time_frame>
    <description>Hemostatic markers including vWF-A2 and CD62b (p-selectin) in pg/mL are evaluated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in lipid and glucose profiles analysed by medical diagnostic laboratory</measure>
    <time_frame>8 weeks</time_frame>
    <description>Total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol, VLDL-cholesterol, and fasting blood glucose in mmol/L are evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in liver enzymes analysed by medical diagnostic laboratory</measure>
    <time_frame>8 weeks</time_frame>
    <description>Serum levels of alanine transaminase (ALT), aspartate transaminase (AST), alkaline Phosphatase (ALP) and gamma glutamyl transferase (GGT) in IU/L are determined.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in renal function analysed by medical diagnostic laboratory</measure>
    <time_frame>8 weeks</time_frame>
    <description>Serum levels of creatinine, urea, and electrolytes (sodium, potassium, and chloride) in mmol/L are determined.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in body mass index (BMI)</measure>
    <time_frame>8 weeks</time_frame>
    <description>Weight and height are combined to report BMI in kg/m^2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in blood pressure</measure>
    <time_frame>8 weeks</time_frame>
    <description>Seated systolic and diastolic blood pressures are taken in mmHg.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Thrombosis</condition>
  <arm_group>
    <arm_group_label>YSS/salmon group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>YSS followed by salmon</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Salmon/YSS group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Salmon followed by YSS</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>YSS</intervention_name>
    <description>Intervention providing steamed whole YSS (~265 g/day, 3 days/week) for eight weeks</description>
    <arm_group_label>Salmon/YSS group</arm_group_label>
    <arm_group_label>YSS/salmon group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Salmon</intervention_name>
    <description>Intervention providing steamed salmon fillet (~246 g/day, 3 days/week) for eight weeks</description>
    <arm_group_label>Salmon/YSS group</arm_group_label>
    <arm_group_label>YSS/salmon group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Malaysian&#xD;
&#xD;
          -  Overweight participants (BMI 23-27.4 kg/m2)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Regular use of fish oil supplements during the last one month&#xD;
&#xD;
          -  Regular consumption of fish twice or more per week&#xD;
&#xD;
          -  Vegetarian who excluded all meat, fish, and poultry from their diet&#xD;
&#xD;
          -  Diagnosed with cardiovascular disease, haemostasis disorder, inflammatory disease,&#xD;
             diabetes mellitus, hypertension, or other significant medical history that may&#xD;
             prohibits the participation&#xD;
&#xD;
          -  Receiving warfarin or aspirin treatment, or medication to lower serum lipids, blood&#xD;
             pressure, and inflammation&#xD;
&#xD;
          -  Women who are menopause, pregnant or lactating&#xD;
      </textblock>
    </criteria>
    <gender>All</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>Su Peng Loh, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universiti Putra Malaysia</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>May 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>August 14, 2017</last_update_submitted>
  <last_update_submitted_qc>August 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universiti Putra Malaysia</investigator_affiliation>
    <investigator_full_name>Dr. Loh Su Peng</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Thrombosis</keyword>
  <keyword>Yellowstripe scad</keyword>
  <keyword>Salmon</keyword>
  <keyword>Healthy overweight subjects</keyword>
  <keyword>Randomized crossover trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
  </condition_browse>
  <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/NCT03251014
org study id: 06-01-04-SF2310
secondary id: NMRR-16-2693-32300.
secondary id: FPSK(FR16)P005
nct id: NCT03251014
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study aimed to determine the thrombotic effects of YSS compared with salmon among healthy
      overweight subjects. It hypothesized that YSS may result significant, favorable thrombotic
      effects and the effects may be similar with salmon.
The project was a randomized, two-period, crossover trial with 8-week treatment periods and
      8-week washout period. A total of 50 healthy overweight adults were recruited among staff and
      students in UPM. All the subjects were randomized into two groups. Each group was served with
      either cooked YSS (~265 g/ day) or salmon (~246 g/day) thrice per week. Blood and urine
      samples were collected for laboratory assessment.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Changes in hemostatic status assessed by immunoassay method
time frame: 8 weeks
description: Hemostatic markers including vWF-A2 and CD62b (p-selectin) in pg/mL are evaluated.
measure: Changes in lipid and glucose profiles analysed by medical diagnostic laboratory
time frame: 8 weeks
description: Total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol, VLDL-cholesterol, and fasting blood glucose in mmol/L are evaluated.
measure: Changes in liver enzymes analysed by medical diagnostic laboratory
time frame: 8 weeks
description: Serum levels of alanine transaminase (ALT), aspartate transaminase (AST), alkaline Phosphatase (ALP) and gamma glutamyl transferase (GGT) in IU/L are determined.
measure: Changes in renal function analysed by medical diagnostic laboratory
time frame: 8 weeks
description: Serum levels of creatinine, urea, and electrolytes (sodium, potassium, and chloride) in mmol/L are determined.
measure: Changes in body mass index (BMI)
time frame: 8 weeks
description: Weight and height are combined to report BMI in kg/m^2
measure: Changes in blood pressure
time frame: 8 weeks
description: Seated systolic and diastolic blood pressures are taken in mmHg.
arm group label: YSS/salmon group
arm group type: Experimental
description: YSS followed by salmon
arm group label: Salmon/YSS group
arm group type: Experimental
description: Salmon followed by YSS
intervention type: Other
intervention name: YSS
description: Intervention providing steamed whole YSS (~265 g/day, 3 days/week) for eight weeks
arm group label: Salmon/YSS group
arm group label: YSS/salmon group
intervention type: Other
intervention name: Salmon
description: Intervention providing steamed salmon fillet (~246 g/day, 3 days/week) for eight weeks
arm group label: Salmon/YSS group
arm group label: YSS/salmon group
criteria: 
gender: All
minimum age: 21 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Su Peng Loh, PhD
role: Principal Investigator
affiliation: Universiti Putra Malaysia
responsible party type: Principal Investigator
investigator affiliation: Universiti Putra Malaysia
investigator full name: Dr. Loh Su Peng
investigator title: Associate Professor
mesh term: Thrombosis
sharing ipd: No