<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/NCT03233906</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-16-188</org_study_id>
    <nct_id>NCT03233906</nct_id>
  </id_info>
  <brief_title>The Effects of Chia on Overweight/Obese Women</brief_title>
  <official_title>Effects of Chia Seed Consumption on Body Composition, Blood Pressure, Blood Glucose, Satiety, Diet Displacement, Joint Pain, Mood and Serotonin Levels in Young, Healthy, Overweight/Obese Females</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>California State Polytechnic University, Pomona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>California State Polytechnic University, Pomona</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 purpose of the study is to examine the effect of chia seed consumption on body&#xD;
      composition, blood pressure, blood glucose, satiety, mood, joint pain, and dietary&#xD;
      displacement in overweight and obese females (18-45years). It is hypothesized that consuming&#xD;
      chia seeds will bring about a positive change in body composition (lower % body fat),&#xD;
      satiety, mood, joint pain, and blood pressure, lower blood glucose levels, increased fiber&#xD;
      and improved nutrient intake, in overweight/ obese females.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specific Objectives: 1. Determine if chia seed diet addition of 10% of Kcals (CHIA)&#xD;
      positively changes body composition in young, healthy, overweight/obese people (Tanita&#xD;
      scale). A) Determine if CHIA will decrease blood pressure (monitor). 2. Determine if CHIA&#xD;
      will decrease blood glucose (draw) 3. Determine if CHIA increases satiety and improves diet&#xD;
      (recordings). 4. Determine if CHIA will decrease joint pain (questionnaire). 5. Determine if&#xD;
      CHIA will increase positive mood changes (questionnaires) and increase blood serotonin levels&#xD;
      (draw).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">May 20, 2017</start_date>
  <completion_date type="Anticipated">August 2018</completion_date>
  <primary_completion_date type="Anticipated">May 2018</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>
    <intervention_model_description>Human subjects- females (18-45 y.o.) with a BMI greater than or equal to 26.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fasting plasma glucose</measure>
    <time_frame>baseline</time_frame>
    <description>12-hour fasting plasma glucose levels will be assessed using a glucometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Waist Circumference</measure>
    <time_frame>baseline</time_frame>
    <description>waist circumference will be measured for each participant</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Caloric intake</measure>
    <time_frame>baseline</time_frame>
    <description>9, 3-day diet journals will be collected using a paper method</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serotonin</measure>
    <time_frame>baseline</time_frame>
    <description>Urine serotonin levels will be assessed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Weight</measure>
    <time_frame>Baseline</time_frame>
    <description>Tanita scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Mass Index</measure>
    <time_frame>Baseline</time_frame>
    <description>Tanita sclae</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Fat Percentage</measure>
    <time_frame>Baseline</time_frame>
    <description>Tanita scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fasting plasma glucose</measure>
    <time_frame>week 4</time_frame>
    <description>2-hour fasting plasma glucose levels will be assessed using a glucometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fasting plasma glucose</measure>
    <time_frame>week 8</time_frame>
    <description>2-hour fasting plasma glucose levels will be assessed using a glucometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Waist Circumference</measure>
    <time_frame>week 4</time_frame>
    <description>waist circumference will be measured for each participant</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Waist Circumference</measure>
    <time_frame>week 8</time_frame>
    <description>waist will be measured for each participant</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Caloric intake</measure>
    <time_frame>week 4</time_frame>
    <description>9, 3-day diet journals will be collected using a paper method</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Caloric intake</measure>
    <time_frame>week 8</time_frame>
    <description>9, 3-day diet journals will be collected using a paper method</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serotonin</measure>
    <time_frame>week 4</time_frame>
    <description>Urine serotonin levels will be assessed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serotonin</measure>
    <time_frame>week 8</time_frame>
    <description>Urine serotonin levels will be assessed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Weight</measure>
    <time_frame>week 4</time_frame>
    <description>tanita scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body weight</measure>
    <time_frame>week 8</time_frame>
    <description>tanita scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body mass index</measure>
    <time_frame>week 4</time_frame>
    <description>tanita scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>body mass index</measure>
    <time_frame>week 8</time_frame>
    <description>tanita scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body fat percentage</measure>
    <time_frame>week 4</time_frame>
    <description>tanita scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body fat percentage</measure>
    <time_frame>week 8</time_frame>
    <description>tanita scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hip Circumference</measure>
    <time_frame>Baseline</time_frame>
    <description>Hip Circumference will be measured for each participant</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hip Circumference</measure>
    <time_frame>week 4</time_frame>
    <description>Hip Circumference will be measured for each participant</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hip Circumference</measure>
    <time_frame>week 8</time_frame>
    <description>Hip Circumference will be measured for each participant</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>baseline</time_frame>
    <description>Blood pressure will be taken using an automatic blood pressure machine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>week 4</time_frame>
    <description>Blood pressure will be taken using an automatic blood pressure machine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>week 8</time_frame>
    <description>Blood pressure will be taken using an automatic blood pressure machine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Joint Pain</measure>
    <time_frame>baseline</time_frame>
    <description>Joint pain will be assessed using The WOMAC (Western Ontario and McMaster Universities) Index of Osteoarthritis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Joint Pain</measure>
    <time_frame>week 4</time_frame>
    <description>Joint pain will be assessed using The WOMAC (Western Ontario and McMaster Universities) Index of Osteoarthritis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Joint Pain</measure>
    <time_frame>week 8</time_frame>
    <description>Joint pain will be assessed using The WOMAC (Western Ontario and McMaster Universities) Index of Osteoarthritis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mood</measure>
    <time_frame>Baseline</time_frame>
    <description>Major Depression Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mood</measure>
    <time_frame>week 4</time_frame>
    <description>Major Depression Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mood</measure>
    <time_frame>week 8</time_frame>
    <description>Major Depression Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity</measure>
    <time_frame>Baseline</time_frame>
    <description>INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE (August 2002) SHORT LAST 7 DAYS SELF-ADMINISTERED FORMAT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity</measure>
    <time_frame>week 4</time_frame>
    <description>INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE (August 2002) SHORT LAST 7 DAYS SELF-ADMINISTERED FORMAT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity</measure>
    <time_frame>week 8</time_frame>
    <description>INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE (August 2002) SHORT LAST 7 DAYS SELF-ADMINISTERED FORMAT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Quality</measure>
    <time_frame>Baseline</time_frame>
    <description>Measuring sleep quality using the Pittsburgh Sleep Quality Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Quality</measure>
    <time_frame>week 4</time_frame>
    <description>Measuring sleep quality using the Pittsburgh Sleep Quality Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Quality</measure>
    <time_frame>week 8</time_frame>
    <description>Measuring sleep quality using the Pittsburgh Sleep Quality Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat mass</measure>
    <time_frame>Baseline</time_frame>
    <description>using a tanita scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat mass</measure>
    <time_frame>week 4</time_frame>
    <description>using a tanita scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat mass</measure>
    <time_frame>week 8</time_frame>
    <description>using a tanita scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat Free Mass</measure>
    <time_frame>Baseline</time_frame>
    <description>using a tanita scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat Free Mass</measure>
    <time_frame>week 4</time_frame>
    <description>using a tanita scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat Free Mass</measure>
    <time_frame>week 8</time_frame>
    <description>using a tanita scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total body water</measure>
    <time_frame>Baseline</time_frame>
    <description>using a tanita scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total body water</measure>
    <time_frame>week 4</time_frame>
    <description>using a tanita scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total body water</measure>
    <time_frame>week 8</time_frame>
    <description>using a tanita scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Macro nutrient intake</measure>
    <time_frame>Baseline</time_frame>
    <description>3, 3-day diet journals will be collected using a paper method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Macro nutrient intake</measure>
    <time_frame>week 4</time_frame>
    <description>3, 3-day diet journals will be collected using a paper method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Macro nutrient intake</measure>
    <time_frame>week 8</time_frame>
    <description>3, 3-day diet journals will be collected using a paper method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Micronutrient intake</measure>
    <time_frame>Baseline</time_frame>
    <description>3, 3-day diet journals will be collected using a paper method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Micronutrient intake</measure>
    <time_frame>week 4</time_frame>
    <description>3, 3-day diet journals will be collected using a paper method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Micronutrient intake</measure>
    <time_frame>week 8</time_frame>
    <description>3, 3-day diet journals will be collected using a paper method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary intake Satiety</measure>
    <time_frame>Baseline</time_frame>
    <description>3, 3-day diet journals will be collected using a paper method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary intake Satiety</measure>
    <time_frame>week 4</time_frame>
    <description>3, 3-day diet journals will be collected using a paper method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary intake Satiety</measure>
    <time_frame>week 8</time_frame>
    <description>3, 3-day diet journals will be collected using a paper method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary intake displacement</measure>
    <time_frame>Baseline</time_frame>
    <description>3, 3-day diet journals will be collected using a paper method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary intake displacement</measure>
    <time_frame>week 4</time_frame>
    <description>3, 3-day diet journals will be collected using a paper method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary intake displacement</measure>
    <time_frame>week 8</time_frame>
    <description>3, 3-day diet journals will be collected using a paper method</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Obesity</condition>
  <condition>Eating Behavior</condition>
  <condition>Mood</condition>
  <condition>Glucose</condition>
  <condition>Dietary Modification</condition>
  <arm_group>
    <arm_group_label>Chia Seeds</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>10% of a participants total kcal estimated needs given in chia seeds everyday for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Habitual diet with avoidance of high fiber and high omega-3 fatty acid foods.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Chia Seeds- Salvia Hispanica</intervention_name>
    <description>Chia seed added-10% of kcals and a no-chia control diet. 10% will be calculated using the following formula: Harris-Benedict equation multiplied by the activity factor of 1.2, 1.375, and 1.55 depending on each participant's activity level based on the information provided on the initial screening form.</description>
    <arm_group_label>Chia Seeds</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  are a female.&#xD;
&#xD;
          -  are between the ages of 18 and 45.&#xD;
&#xD;
          -  are not averse to consuming chia seeds on a regular basis (at least six weeks).&#xD;
&#xD;
          -  have not taken any medication for any chronic disease (heart, diabetes, cancer) for&#xD;
             twelve weeks.&#xD;
&#xD;
          -  have not taken any steroid or hormone medication in the last eight weeks, excluding&#xD;
             birth control pills...&#xD;
&#xD;
          -  do not consume excess amounts of nuts and seeds. - do not consume alcohol on a regular&#xD;
             basis.&#xD;
&#xD;
          -  are not currently on a diet plan.&#xD;
&#xD;
          -  are not pregnant or plan to become pregnant.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  are a child, teenager, woman, or male younger than 18 or older than 45.&#xD;
&#xD;
          -  eat large quantities of chia seeds on a regular basis.&#xD;
&#xD;
          -  are taking any steroid or hormone medication (other than birth control pills). - are&#xD;
             taking laxatives or fiber containing supplements on a regular basis.&#xD;
&#xD;
          -  are pregnant or become pregnant.&#xD;
&#xD;
          -  are currently on a diet plan.&#xD;
&#xD;
          -  have a known allergy to seeds.&#xD;
&#xD;
          -  consume excess amounts of seeds or nuts.&#xD;
&#xD;
          -  consume alcohol on a regular basis.&#xD;
&#xD;
          -  have a pacemaker or metal pins or plates in the body.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bonny Burns-Whitmore, DrPh, RD</last_name>
    <role>Study Director</role>
    <affiliation>California State Polytechnic University, Pomona</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>California State Polytechnic University, Pomona</name>
      <address>
        <city>Pomona</city>
        <state>California</state>
        <zip>91766</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>July 17, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>May 8, 2018</last_update_submitted>
  <last_update_submitted_qc>May 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>California State Polytechnic University, Pomona</investigator_affiliation>
    <investigator_full_name>Desiree Vera</investigator_full_name>
    <investigator_title>Graduate Student, Human Nutrition and Food Science</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</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/NCT03233906
org study id: IRB-16-188
nct id: NCT03233906
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to examine the effect of chia seed consumption on body
      composition, blood pressure, blood glucose, satiety, mood, joint pain, and dietary
      displacement in overweight and obese females (18-45years). It is hypothesized that consuming
      chia seeds will bring about a positive change in body composition (lower % body fat),
      satiety, mood, joint pain, and blood pressure, lower blood glucose levels, increased fiber
      and improved nutrient intake, in overweight/ obese females.
Specific Objectives: 1. Determine if chia seed diet addition of 10% of Kcals (CHIA)
      positively changes body composition in young, healthy, overweight/obese people (Tanita
      scale). A) Determine if CHIA will decrease blood pressure (monitor). 2. Determine if CHIA
      will decrease blood glucose (draw) 3. Determine if CHIA increases satiety and improves diet
      (recordings). 4. Determine if CHIA will decrease joint pain (questionnaire). 5. Determine if
      CHIA will increase positive mood changes (questionnaires) and increase blood serotonin levels
      (draw).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Human subjects- females (18-45 y.o.) with a BMI greater than or equal to 26.
primary purpose: Treatment
masking: None (Open Label)
measure: Fasting plasma glucose
time frame: baseline
description: 12-hour fasting plasma glucose levels will be assessed using a glucometer
measure: Waist Circumference
time frame: baseline
description: waist circumference will be measured for each participant
measure: Caloric intake
time frame: baseline
description: 9, 3-day diet journals will be collected using a paper method
measure: Serotonin
time frame: baseline
description: Urine serotonin levels will be assessed
measure: Body Weight
time frame: Baseline
description: Tanita scale
measure: Body Mass Index
time frame: Baseline
description: Tanita sclae
measure: Body Fat Percentage
time frame: Baseline
description: Tanita scale
measure: Fasting plasma glucose
time frame: week 4
description: 2-hour fasting plasma glucose levels will be assessed using a glucometer
measure: Fasting plasma glucose
time frame: week 8
description: 2-hour fasting plasma glucose levels will be assessed using a glucometer
measure: Waist Circumference
time frame: week 4
description: waist circumference will be measured for each participant
measure: Waist Circumference
time frame: week 8
description: waist will be measured for each participant
measure: Caloric intake
time frame: week 4
description: 9, 3-day diet journals will be collected using a paper method
measure: Caloric intake
time frame: week 8
description: 9, 3-day diet journals will be collected using a paper method
measure: Serotonin
time frame: week 4
description: Urine serotonin levels will be assessed
measure: Serotonin
time frame: week 8
description: Urine serotonin levels will be assessed
measure: Body Weight
time frame: week 4
description: tanita scale
measure: Body weight
time frame: week 8
description: tanita scale
measure: Body mass index
time frame: week 4
description: tanita scale
measure: body mass index
time frame: week 8
description: tanita scale
measure: Body fat percentage
time frame: week 4
description: tanita scale
measure: Body fat percentage
time frame: week 8
description: tanita scale
measure: Hip Circumference
time frame: Baseline
description: Hip Circumference will be measured for each participant
measure: Hip Circumference
time frame: week 4
description: Hip Circumference will be measured for each participant
measure: Hip Circumference
time frame: week 8
description: Hip Circumference will be measured for each participant
measure: Blood Pressure
time frame: baseline
description: Blood pressure will be taken using an automatic blood pressure machine
measure: Blood Pressure
time frame: week 4
description: Blood pressure will be taken using an automatic blood pressure machine
measure: Blood Pressure
time frame: week 8
description: Blood pressure will be taken using an automatic blood pressure machine
measure: Joint Pain
time frame: baseline
description: Joint pain will be assessed using The WOMAC (Western Ontario and McMaster Universities) Index of Osteoarthritis
measure: Joint Pain
time frame: week 4
description: Joint pain will be assessed using The WOMAC (Western Ontario and McMaster Universities) Index of Osteoarthritis
measure: Joint Pain
time frame: week 8
description: Joint pain will be assessed using The WOMAC (Western Ontario and McMaster Universities) Index of Osteoarthritis
measure: Mood
time frame: Baseline
description: Major Depression Inventory
measure: Mood
time frame: week 4
description: Major Depression Inventory
measure: Mood
time frame: week 8
description: Major Depression Inventory
measure: Physical Activity
time frame: Baseline
description: INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE (August 2002) SHORT LAST 7 DAYS SELF-ADMINISTERED FORMAT
measure: Physical Activity
time frame: week 4
description: INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE (August 2002) SHORT LAST 7 DAYS SELF-ADMINISTERED FORMAT
measure: Physical Activity
time frame: week 8
description: INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE (August 2002) SHORT LAST 7 DAYS SELF-ADMINISTERED FORMAT
measure: Sleep Quality
time frame: Baseline
description: Measuring sleep quality using the Pittsburgh Sleep Quality Index
measure: Sleep Quality
time frame: week 4
description: Measuring sleep quality using the Pittsburgh Sleep Quality Index
measure: Sleep Quality
time frame: week 8
description: Measuring sleep quality using the Pittsburgh Sleep Quality Index
measure: Fat mass
time frame: Baseline
description: using a tanita scale
measure: Fat mass
time frame: week 4
description: using a tanita scale
measure: Fat mass
time frame: week 8
description: using a tanita scale
measure: Fat Free Mass
time frame: Baseline
description: using a tanita scale
measure: Fat Free Mass
time frame: week 4
description: using a tanita scale
measure: Fat Free Mass
time frame: week 8
description: using a tanita scale
measure: Total body water
time frame: Baseline
description: using a tanita scale
measure: Total body water
time frame: week 4
description: using a tanita scale
measure: Total body water
time frame: week 8
description: using a tanita scale
measure: Macro nutrient intake
time frame: Baseline
description: 3, 3-day diet journals will be collected using a paper method
measure: Macro nutrient intake
time frame: week 4
description: 3, 3-day diet journals will be collected using a paper method
measure: Macro nutrient intake
time frame: week 8
description: 3, 3-day diet journals will be collected using a paper method
measure: Micronutrient intake
time frame: Baseline
description: 3, 3-day diet journals will be collected using a paper method
measure: Micronutrient intake
time frame: week 4
description: 3, 3-day diet journals will be collected using a paper method
measure: Micronutrient intake
time frame: week 8
description: 3, 3-day diet journals will be collected using a paper method
measure: Dietary intake Satiety
time frame: Baseline
description: 3, 3-day diet journals will be collected using a paper method
measure: Dietary intake Satiety
time frame: week 4
description: 3, 3-day diet journals will be collected using a paper method
measure: Dietary intake Satiety
time frame: week 8
description: 3, 3-day diet journals will be collected using a paper method
measure: Dietary intake displacement
time frame: Baseline
description: 3, 3-day diet journals will be collected using a paper method
measure: Dietary intake displacement
time frame: week 4
description: 3, 3-day diet journals will be collected using a paper method
measure: Dietary intake displacement
time frame: week 8
description: 3, 3-day diet journals will be collected using a paper method
arm group label: Chia Seeds
arm group type: Active Comparator
description: 10% of a participants total kcal estimated needs given in chia seeds everyday for 8 weeks.
arm group label: Control
arm group type: No Intervention
description: Habitual diet with avoidance of high fiber and high omega-3 fatty acid foods.
intervention type: Dietary Supplement
intervention name: Chia Seeds- Salvia Hispanica
description: Chia seed added-10% of kcals and a no-chia control diet. 10% will be calculated using the following formula: Harris-Benedict equation multiplied by the activity factor of 1.2, 1.375, and 1.55 depending on each participant's activity level based on the information provided on the initial screening form.
arm group label: Chia Seeds
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bonny Burns-Whitmore, DrPh, RD
role: Study Director
affiliation: California State Polytechnic University, Pomona
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: California State Polytechnic University, Pomona
investigator full name: Desiree Vera
investigator title: Graduate Student, Human Nutrition and Food Science
mesh term: Overweight
sharing ipd: No