<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/NCT01692990</url>
  </required_header>
  <id_info>
    <org_study_id>LL-spec1</org_study_id>
    <nct_id>NCT01692990</nct_id>
  </id_info>
  <brief_title>Study on the Effect of Fish Oil and Appetite</brief_title>
  <official_title>Study on the Effect of Fish Oil and Appetite</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AAstrup</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Copenhagen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      20 normal-weight healthy subjects (10 males, 10 females) were in two periods given 10 of&#xD;
      0.5-mL capsules/day of fish oil and soybean oil for 3 weeks. In the end of each period they&#xD;
      were given a standard breakfast and asked to report their appetite on visual analogue scales&#xD;
      (VAS) immediately before and after the meal. The results were analyzed in accordance with the&#xD;
      paired design under consideration of both supplement sequence and gender.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In a randomized cross-over design, 20 normal-weight healthy subjects (10 males, 10 females)&#xD;
      were given 10 of 0.5-mL capsules/day of fish oil and soybean oil for 3 weeks. In the end of&#xD;
      each period they were given a standard breakfast and asked to report their appetite on visual&#xD;
      analogue scales (VAS) immediately before and after the meal. The results were analyzed in&#xD;
      accordance with the paired design under consideration of both supplement sequence and gender.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">November 2011</completion_date>
  <primary_completion_date type="Actual">November 2011</primary_completion_date>
  <phase>Early Phase 1</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>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Appetite and satiation</measure>
    <time_frame>October 7th - November 25th 2011</time_frame>
    <description>Appetite and satiation were measured by visual analogue scales (VAS), which assessed satiation, hunger, fullness and desire to eat. Each scale was 100 mm in length with words anchored at each end, expressing the most positive and negative rating of each category.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weight change</measure>
    <time_frame>October 7th - November 25th 2011</time_frame>
    <description>Body weight was measured on the same scale without shoes and wearing light clothing in the morning before breakfast.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Obesity</condition>
  <condition>Cachexia</condition>
  <arm_group>
    <arm_group_label>Fish oil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 g/d in 10 capsules, providing 3.5 g of long-chain n-3 fatty acids</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Soy bean oil</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>5 g/d in 10 capsules</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Fish oil</intervention_name>
    <description>For 3 weeks 5 g/d in 10 capsules, providing 3.5 g long-chain n-3 fatty acids in the fish oil period. Cross-over between arms with 1 week of wash out</description>
    <arm_group_label>Fish oil</arm_group_label>
    <arm_group_label>Soy bean oil</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Normal weight (18.5&lt;BMI&lt;25 kg/m2).&#xD;
&#xD;
          -  Healthy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects taking medication that could influence appetite.&#xD;
&#xD;
          -  Subjects with special nutritional needs e.g. pregnant and lactating, seriously ill or&#xD;
             old people.&#xD;
&#xD;
          -  Subjects that had had fish oil-supplements for four weeks prior to the intervention&#xD;
             period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lotte Lauritzen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Human Nutrition</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Human Nutrition</name>
      <address>
        <city>Frederiksberg</city>
        <zip>1958</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>May 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>November 9, 2012</last_update_submitted>
  <last_update_submitted_qc>November 9, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 12, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Copenhagen</investigator_affiliation>
    <investigator_full_name>AAstrup</investigator_full_name>
    <investigator_title>Associate Professore Lotte Lauritzen</investigator_title>
  </responsible_party>
  <keyword>Appetite</keyword>
  <keyword>Fish oil</keyword>
  <keyword>Long-chain n-3 fatty acids</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cachexia</mesh_term>
  </condition_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/NCT01692990
org study id: LL-spec1
nct id: NCT01692990
lead sponsor: 
has dmc: No
20 normal-weight healthy subjects (10 males, 10 females) were in two periods given 10 of
      0.5-mL capsules/day of fish oil and soybean oil for 3 weeks. In the end of each period they
      were given a standard breakfast and asked to report their appetite on visual analogue scales
      (VAS) immediately before and after the meal. The results were analyzed in accordance with the
      paired design under consideration of both supplement sequence and gender.
In a randomized cross-over design, 20 normal-weight healthy subjects (10 males, 10 females)
      were given 10 of 0.5-mL capsules/day of fish oil and soybean oil for 3 weeks. In the end of
      each period they were given a standard breakfast and asked to report their appetite on visual
      analogue scales (VAS) immediately before and after the meal. The results were analyzed in
      accordance with the paired design under consideration of both supplement sequence and gender.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Appetite and satiation
time frame: October 7th - November 25th 2011
description: Appetite and satiation were measured by visual analogue scales (VAS), which assessed satiation, hunger, fullness and desire to eat. Each scale was 100 mm in length with words anchored at each end, expressing the most positive and negative rating of each category.
measure: Weight change
time frame: October 7th - November 25th 2011
description: Body weight was measured on the same scale without shoes and wearing light clothing in the morning before breakfast.
arm group label: Fish oil
arm group type: Experimental
description: 5 g/d in 10 capsules, providing 3.5 g of long-chain n-3 fatty acids
arm group label: Soy bean oil
arm group type: Placebo Comparator
description: 5 g/d in 10 capsules
intervention type: Dietary Supplement
intervention name: Fish oil
description: For 3 weeks 5 g/d in 10 capsules, providing 3.5 g long-chain n-3 fatty acids in the fish oil period. Cross-over between arms with 1 week of wash out
arm group label: Fish oil
arm group label: Soy bean oil
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lotte Lauritzen, PhD
role: Principal Investigator
affiliation: Department of Human Nutrition
facility: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: University of Copenhagen
investigator full name: AAstrup
investigator title: Associate Professore Lotte Lauritzen
mesh term: Cachexia