<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/NCT02199054</url>
  </required_header>
  <id_info>
    <org_study_id>2014H0045</org_study_id>
    <secondary_id>2013</secondary_id>
    <nct_id>NCT02199054</nct_id>
  </id_info>
  <brief_title>Functional Snack Foods With Safflower Oil and Soy in Postmenopausal Women Having Metabolic Syndrome</brief_title>
  <official_title>Evaluation of Functional Snack Foods Containing Safflower Oil and Soy on Endpoints of Energy Metabolism in Postmenopausal Women With Metabolic Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study is being done to help researchers develop new dietary options for&#xD;
      menopausal women to maintain a healthy weight by developing more nutritious snacks that have&#xD;
      health benefits. From this study, the researchers hope to gain understanding on how&#xD;
      menopausal women with metabolic syndrome digest and absorb foods with safflower oil on its&#xD;
      own and when combined with soy. The research team hypothesize that the two different types of&#xD;
      pretzels may be processed by your body differently and that components in the pretzel snacks&#xD;
      may be helpful for preventing diseases like obesity and cancer. Safflower oil and soybeans&#xD;
      contain many natural chemicals that may benefit human health. However, this relationship is&#xD;
      not well understood. This study will look at the impact of the pretzel snacks on your blood&#xD;
      fat and glucose levels as well as a group of chemicals found in soy called &quot;isoflavones&quot;.&#xD;
      Isoflavones are natural chemicals found commonly in soybeans or foods made from them.&#xD;
&#xD;
      Participants will be screened to determine if they qualify in meeting the study requirements.&#xD;
      Participants cannot have a known allergy to dairy, soy, safflower oil, or wheat protein.&#xD;
      Also, participants will be asked to stop eating legumes (beans, peas, soy protein, sprouts&#xD;
      and peanuts) and to document the oils they eat for the entire 14 weeks of this study. The&#xD;
      study will require five visits to the Ohio State University Clinical Research Center (CRC)&#xD;
      which part of the Ohio State University's Center for Clinical and Translational Sciences.&#xD;
      Once the investigators have determined that you qualify for this study and you decide to&#xD;
      participate, you will be consuming three different pretzels each for one month, starting with&#xD;
      a control pretzel. After the control pretzel treatment period, you will be randomly assigned&#xD;
      (like the &quot;flip of a coin&quot;) to start with one of the two pretzel groups (wheat or soy pretzel&#xD;
      with safflower oil) for your first treatment period and then switch to the other safflower&#xD;
      oil pretzel at your second treatment period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overarching goal is to develop new dietary strategies to help postmenopausal women&#xD;
      maintain a healthy weight by improving the availability of nutritious snacks that contain&#xD;
      added health benefits and will be used to assess the impact of a functional snack on snacking&#xD;
      behavior. The primary objective is to evaluate safflower oil delivered in a wheat pretzel&#xD;
      compared to a wheat pretzel enhanced with soy will have a greater affect on blood&#xD;
      triglyceride and glucose levels thereby affecting satiety and snacking behavior. The&#xD;
      investigators hypothesize that a functional snack food such as a soft pretzel containing&#xD;
      safflower oil either with or without soy compared to the control pretzel (wheat pretzel with&#xD;
      no safflower oil) will reduce postprandial blood triglycerides and glucose.&#xD;
&#xD;
      This proposed multidisciplinary study is a randomized cross-over trial involving 20&#xD;
      overweight (BMI &gt; 25 kg/m2) postmenopausal women with metabolic syndrome will participate in&#xD;
      a dietary intervention study for a total of 14 weeks (two weeks of washout and three 4 week&#xD;
      interventions). The study will require five visits to the Ohio State University Clinical&#xD;
      Research Center (CRC), part of the Center for Clinical and Translational Sciences, Figure 5.&#xD;
      Women will visit the CRC to be screened (Day-14) and their eligibility will be determined&#xD;
      using a health and lifestyle questionnaire and results from a 12 hour fasting lipid panel&#xD;
      (total cholesterol, LDL, HDL, triglycerides). Those meeting the National Cholesterol&#xD;
      Education Program criteria for metabolic syndrome and having no other excluding conditions&#xD;
      will be enrolled. Prior to their oral triglyceride tolerance tests (OTTT), women will be&#xD;
      instructed to abstain from a. alcohol consumption for 72 hour, b. consume ≥150g of&#xD;
      carbohydrates for 24 hours, c. abstain from vigorous exercise for 24 hours, d. collect urine&#xD;
      for 24 hours, e. fast for 12 hours prior to all their clinic visits. When women arrive at the&#xD;
      CRC for their clinic visits, weight and vital signs will be collected and a venous catheter&#xD;
      placed for timed blood collections. Blood will be collected for serum triglycerides and&#xD;
      glucose prior to (-5 minutes) and at 30, 60, 90, 120, 150, 180, 240, 300, and 360 minutes&#xD;
      after consumption of the test meal. At their run-in visit (Day 0), subjects will consume a&#xD;
      control pretzel with a flavored oil dip containing a standardized quantity of triglycerides&#xD;
      (50 g long chain fatty acids). At the first treatment period (Day 28) visit, women will be&#xD;
      randomized to one of the two intervention groups (wheat or soy pretzel with safflower oil)&#xD;
      and then crossover to the other safflower oil pretzel at their second treatment period visit&#xD;
      (Day 56). The two intervention pretzel meals will be accompanied with the same oil dip&#xD;
      provided before. At the end of each OTTT visit women will be instructed to continue eating&#xD;
      the test pretzels (12 pretzel bites/day) for the next 28 days as a snack. Subjects will be&#xD;
      instructed to complete questions pertaining to their satiety during their 7 hour stay. Women&#xD;
      will return for their last visit on Day 84 to submit all completed study materials (survey,&#xD;
      dietary recall, and daily intake journal), completed 24 hour urine collection, and blood&#xD;
      collection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants having Serious and Non-serious Adverse Events.</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Standardized qualitative and quantitative toxicity criteria (NIH) will be employed to evaluate safety and toxicity of daily safflower oil consumption.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with 80% Adherence to Safflower Oil Pretzels</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>The daily consumption of safflower oil pretzels with and without soy will be assessed with a daily dietary intake journal as well as with measures of isoflavone and linoleic acid metabolites in urine and blood, respectively.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Improved Satiety Visual Analogue Scale (VAS) with Safflower Oil Pretzel Snacks Compared to Control Pretzels.</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>The impact of safflower oil pretzels with and without soy on snacking behavior and satiety will be measured by comparing visual analogue scale surveys, food frequency questionnaires, and total energy intake extracted from 24 hour dietary recalls.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Concentration-Time Curve for Serum Triglyceride and Glucose</measure>
    <time_frame>Before test meal, 30, 60, 90, 120, 150, 180, 240, 300, and 360 minutes after the test meal on Days 0, 28, and 56</time_frame>
    <description>Postprandial triglycerides and glucose following consumption of a single meal consisting of safflower oil pretzels with or without soy will be compared to a control pretzel having neither safflower oil nor soy.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Identify Number of Participants with Changes in Blood Gene Expression from Day 0 Compared to Day 84.</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Impact of safflower oil consumption on gene expression profiles and biomarkers relevant to energy metabolism will be examined and correlated to their isoflavonoid metabolic profile.</description>
  </other_outcome>
  <other_outcome>
    <measure>Isoflavone Metabolite Profile Collected from Urine on Days 0, 28, 56, and 84</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Women will be classified by their isoflavone metabolites in urine and correlated with biological effects of safflower oil pretzel intervention and gene expression</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Metabolic Syndrome</condition>
  <condition>Overweight</condition>
  <arm_group>
    <arm_group_label>Run-in Intervention</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Control wheat pretzel bites (12 pieces total) will be consumed with a flavored oil dip containing a standardized quantity of triglycerides (50 g long chain fatty acids) at the start of a 7 hour clinic visit as well as 6 pieces of control wheat pretzels will be eaten twice a day (total of 12 pieces/day) for 28 days. During these 28 days, participants will monitor their oil consumption and maintain a legume-free diet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wheat-Safflower Oil Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Wheat-safflower oil pretzel bites (12 pieces total) will be consumed with a flavored oil dip containing a standardized quantity of triglycerides (50 g long chain fatty acids) at the start of a 7 hour clinic visit as well as 6 pieces of wheat-safflower oil pretzels will be eaten twice a day (total of 12 pieces/day) for 28 days. During these 28 days, participants will monitor their oil consumption and maintain a legume-free diet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Soy-Safflower Oil Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Soy-safflower oil pretzel bites (12 pieces total) will be consumed with a flavored oil dip containing a standardized quantity of triglycerides (50 g long chain fatty acids) at the start of a 7 hour clinic visit as well as 6 pieces of soy-safflower oil pretzels will be eaten twice a day (total of 12 pieces/day) for 28 days. During these 28 days, participants will monitor their oil consumption and maintain a legume-free diet.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>wheat-safflower oil pretzels</intervention_name>
    <description>Each serving (6 pieces) of the wheat-safflower oil pretzel contains 6 grams of safflower oil. Ingredients in the pretzel are high gluten wheat flour, safflower oil, sugar, yeast, salt, and ascorbic acid.</description>
    <arm_group_label>Wheat-Safflower Oil Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>soy-safflower oil pretzels</intervention_name>
    <description>Each serving (6 pieces) of the soy-safflower oil pretzel contains 6 grams of safflower oil. Ingredients in the pretzel are high gluten wheat flour, soy flour, soymilk, safflower oil, sugar, yeast, salt, and ascorbic acid.</description>
    <arm_group_label>Soy-Safflower Oil Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>control wheat pretzels</intervention_name>
    <description>Each serving (6 pieces) of the control wheat pretzel contains 6 grams of vegetable shortening. Ingredients in the pretzel are high gluten wheat flour, vegetable shortening, sugar, yeast, salt, and ascorbic acid.</description>
    <arm_group_label>Run-in Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Postmenopausal women 45 to 70 years of age&#xD;
&#xD;
          -  Stated to be postmenopausal and has a cessation of menstruation for greater than 12&#xD;
             months&#xD;
&#xD;
          -  Have a body mass index ≥25 kg/m2&#xD;
&#xD;
          -  Must meet three of the five following criteria12&#xD;
&#xD;
               1. Have a waist circumference greater than 35 inches&#xD;
&#xD;
               2. Fasting serum triglycerides of greater than 150 mg/dL&#xD;
&#xD;
               3. Fasting high density lipoprotein (HDL) less than 40 mg/dL&#xD;
&#xD;
               4. Fasting blood glucose greater than 100 mg/dL&#xD;
&#xD;
               5. Systolic blood pressure greater than 130 mm Hg or diastolic blood pressure&#xD;
                  greater than 85 mm Hg&#xD;
&#xD;
          -  Agree to consume a standardized vitamin/mineral supplement and avoid other nutrition&#xD;
             and alternative supplements for the duration of the study&#xD;
&#xD;
          -  Agree to follow a legume free diet and to document any accidental consumption of&#xD;
             restricted foods each day of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have an active metabolic or digestive illness including malabsorptive disorders, renal&#xD;
             insufficiency, hepatic insufficiency, or had recent (within the year) gastrointestinal&#xD;
             surgery.&#xD;
&#xD;
          -  Have a history or have active hormone related diseases of the pituitary, thyroid or&#xD;
             pancreas that currently require supplemental hormonal administration thyroid hormones,&#xD;
             adrenocorticotropic hormone (ACTH), growth hormone or other endocrine disorders&#xD;
             requiring hormone or insulin administration&#xD;
&#xD;
          -  Have an active or a recent history of any condition that causes altered immunity such&#xD;
             as chronic inflammatory disease, autoimmune disorders, cancer, anemia, and blood&#xD;
             dyscrasias&#xD;
&#xD;
          -  Are on cholesterol lowering medications which include but not limited to statins,&#xD;
             niacin (vitamin B3), bile-acid resins, fibric acid derivatives, or cholesterol&#xD;
             absorption inhibitors.&#xD;
&#xD;
          -  Have a known allergy or food intolerance to ingredients in study products (wheat, soy,&#xD;
             or safflower oil)&#xD;
&#xD;
          -  Are strict vegans (no consumption of animal, fish or egg products)&#xD;
&#xD;
          -  Are heavy alcohol consumers (defined as an average consumption of greater than 14&#xD;
             drinks/week)&#xD;
&#xD;
          -  Have a history of cancer or currently undergoing treatment for cancer&#xD;
&#xD;
          -  Have been on an antibiotic regime lasting for more than one week in the last 6 months&#xD;
&#xD;
          -  Are currently on another study for weight loss or trying to actively lose weight or&#xD;
             recently (last 3 months) started medications for weight loss.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yael Vodovotz, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ohio State University Wexner Medical Center Clinical Research Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 19, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>December 9, 2022</last_update_submitted>
  <last_update_submitted_qc>December 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Yael Vodovotz</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Snack Foods</keyword>
  <keyword>Safflower Oil</keyword>
  <keyword>Soy</keyword>
  <keyword>Postmenopausal women</keyword>
  <keyword>Metabolic Syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT02199054
org study id: 2014H0045
secondary id: 2013
nct id: NCT02199054
lead sponsor: 
has dmc: Yes
This research study is being done to help researchers develop new dietary options for
      menopausal women to maintain a healthy weight by developing more nutritious snacks that have
      health benefits. From this study, the researchers hope to gain understanding on how
      menopausal women with metabolic syndrome digest and absorb foods with safflower oil on its
      own and when combined with soy. The research team hypothesize that the two different types of
      pretzels may be processed by your body differently and that components in the pretzel snacks
      may be helpful for preventing diseases like obesity and cancer. Safflower oil and soybeans
      contain many natural chemicals that may benefit human health. However, this relationship is
      not well understood. This study will look at the impact of the pretzel snacks on your blood
      fat and glucose levels as well as a group of chemicals found in soy called "isoflavones".
      Isoflavones are natural chemicals found commonly in soybeans or foods made from them.

      Participants will be screened to determine if they qualify in meeting the study requirements.
      Participants cannot have a known allergy to dairy, soy, safflower oil, or wheat protein.
      Also, participants will be asked to stop eating legumes (beans, peas, soy protein, sprouts
      and peanuts) and to document the oils they eat for the entire 14 weeks of this study. The
      study will require five visits to the Ohio State University Clinical Research Center (CRC)
      which part of the Ohio State University's Center for Clinical and Translational Sciences.
      Once the investigators have determined that you qualify for this study and you decide to
      participate, you will be consuming three different pretzels each for one month, starting with
      a control pretzel. After the control pretzel treatment period, you will be randomly assigned
      (like the "flip of a coin") to start with one of the two pretzel groups (wheat or soy pretzel
      with safflower oil) for your first treatment period and then switch to the other safflower
      oil pretzel at your second treatment period.
The overarching goal is to develop new dietary strategies to help postmenopausal women
      maintain a healthy weight by improving the availability of nutritious snacks that contain
      added health benefits and will be used to assess the impact of a functional snack on snacking
      behavior. The primary objective is to evaluate safflower oil delivered in a wheat pretzel
      compared to a wheat pretzel enhanced with soy will have a greater affect on blood
      triglyceride and glucose levels thereby affecting satiety and snacking behavior. The
      investigators hypothesize that a functional snack food such as a soft pretzel containing
      safflower oil either with or without soy compared to the control pretzel (wheat pretzel with
      no safflower oil) will reduce postprandial blood triglycerides and glucose.

      This proposed multidisciplinary study is a randomized cross-over trial involving 20
      overweight (BMI > 25 kg/m2) postmenopausal women with metabolic syndrome will participate in
      a dietary intervention study for a total of 14 weeks (two weeks of washout and three 4 week
      interventions). The study will require five visits to the Ohio State University Clinical
      Research Center (CRC), part of the Center for Clinical and Translational Sciences, Figure 5.
      Women will visit the CRC to be screened (Day-14) and their eligibility will be determined
      using a health and lifestyle questionnaire and results from a 12 hour fasting lipid panel
      (total cholesterol, LDL, HDL, triglycerides). Those meeting the National Cholesterol
      Education Program criteria for metabolic syndrome and having no other excluding conditions
      will be enrolled. Prior to their oral triglyceride tolerance tests (OTTT), women will be
      instructed to abstain from a. alcohol consumption for 72 hour, b. consume ≥150g of
      carbohydrates for 24 hours, c. abstain from vigorous exercise for 24 hours, d. collect urine
      for 24 hours, e. fast for 12 hours prior to all their clinic visits. When women arrive at the
      CRC for their clinic visits, weight and vital signs will be collected and a venous catheter
      placed for timed blood collections. Blood will be collected for serum triglycerides and
      glucose prior to (-5 minutes) and at 30, 60, 90, 120, 150, 180, 240, 300, and 360 minutes
      after consumption of the test meal. At their run-in visit (Day 0), subjects will consume a
      control pretzel with a flavored oil dip containing a standardized quantity of triglycerides
      (50 g long chain fatty acids). At the first treatment period (Day 28) visit, women will be
      randomized to one of the two intervention groups (wheat or soy pretzel with safflower oil)
      and then crossover to the other safflower oil pretzel at their second treatment period visit
      (Day 56). The two intervention pretzel meals will be accompanied with the same oil dip
      provided before. At the end of each OTTT visit women will be instructed to continue eating
      the test pretzels (12 pretzel bites/day) for the next 28 days as a snack. Subjects will be
      instructed to complete questions pertaining to their satiety during their 7 hour stay. Women
      will return for their last visit on Day 84 to submit all completed study materials (survey,
      dietary recall, and daily intake journal), completed 24 hour urine collection, and blood
      collection.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Number of Participants having Serious and Non-serious Adverse Events.
time frame: Up to 3 months
description: Standardized qualitative and quantitative toxicity criteria (NIH) will be employed to evaluate safety and toxicity of daily safflower oil consumption.
measure: Number of Participants with 80% Adherence to Safflower Oil Pretzels
time frame: Up to 3 months
description: The daily consumption of safflower oil pretzels with and without soy will be assessed with a daily dietary intake journal as well as with measures of isoflavone and linoleic acid metabolites in urine and blood, respectively.
measure: Number of Participants with Improved Satiety Visual Analogue Scale (VAS) with Safflower Oil Pretzel Snacks Compared to Control Pretzels.
time frame: Up to 3 months
description: The impact of safflower oil pretzels with and without soy on snacking behavior and satiety will be measured by comparing visual analogue scale surveys, food frequency questionnaires, and total energy intake extracted from 24 hour dietary recalls.
measure: Area Under the Concentration-Time Curve for Serum Triglyceride and Glucose
time frame: Before test meal, 30, 60, 90, 120, 150, 180, 240, 300, and 360 minutes after the test meal on Days 0, 28, and 56
description: Postprandial triglycerides and glucose following consumption of a single meal consisting of safflower oil pretzels with or without soy will be compared to a control pretzel having neither safflower oil nor soy.
measure: Identify Number of Participants with Changes in Blood Gene Expression from Day 0 Compared to Day 84.
time frame: Up to 3 months
description: Impact of safflower oil consumption on gene expression profiles and biomarkers relevant to energy metabolism will be examined and correlated to their isoflavonoid metabolic profile.
measure: Isoflavone Metabolite Profile Collected from Urine on Days 0, 28, 56, and 84
time frame: Up to 3 months
description: Women will be classified by their isoflavone metabolites in urine and correlated with biological effects of safflower oil pretzel intervention and gene expression
arm group label: Run-in Intervention
arm group type: Placebo Comparator
description: Control wheat pretzel bites (12 pieces total) will be consumed with a flavored oil dip containing a standardized quantity of triglycerides (50 g long chain fatty acids) at the start of a 7 hour clinic visit as well as 6 pieces of control wheat pretzels will be eaten twice a day (total of 12 pieces/day) for 28 days. During these 28 days, participants will monitor their oil consumption and maintain a legume-free diet.
arm group label: Wheat-Safflower Oil Arm
arm group type: Active Comparator
description: Wheat-safflower oil pretzel bites (12 pieces total) will be consumed with a flavored oil dip containing a standardized quantity of triglycerides (50 g long chain fatty acids) at the start of a 7 hour clinic visit as well as 6 pieces of wheat-safflower oil pretzels will be eaten twice a day (total of 12 pieces/day) for 28 days. During these 28 days, participants will monitor their oil consumption and maintain a legume-free diet.
arm group label: Soy-Safflower Oil Arm
arm group type: Active Comparator
description: Soy-safflower oil pretzel bites (12 pieces total) will be consumed with a flavored oil dip containing a standardized quantity of triglycerides (50 g long chain fatty acids) at the start of a 7 hour clinic visit as well as 6 pieces of soy-safflower oil pretzels will be eaten twice a day (total of 12 pieces/day) for 28 days. During these 28 days, participants will monitor their oil consumption and maintain a legume-free diet.
intervention type: Other
intervention name: wheat-safflower oil pretzels
description: Each serving (6 pieces) of the wheat-safflower oil pretzel contains 6 grams of safflower oil. Ingredients in the pretzel are high gluten wheat flour, safflower oil, sugar, yeast, salt, and ascorbic acid.
arm group label: Wheat-Safflower Oil Arm
intervention type: Other
intervention name: soy-safflower oil pretzels
description: Each serving (6 pieces) of the soy-safflower oil pretzel contains 6 grams of safflower oil. Ingredients in the pretzel are high gluten wheat flour, soy flour, soymilk, safflower oil, sugar, yeast, salt, and ascorbic acid.
arm group label: Soy-Safflower Oil Arm
intervention type: Other
intervention name: control wheat pretzels
description: Each serving (6 pieces) of the control wheat pretzel contains 6 grams of vegetable shortening. Ingredients in the pretzel are high gluten wheat flour, vegetable shortening, sugar, yeast, salt, and ascorbic acid.
arm group label: Run-in Intervention
criteria: 
gender: Female
minimum age: 45 Years
maximum age: 70 Years
healthy volunteers: No
last name: Yael Vodovotz, Ph.D.
role: Principal Investigator
affiliation: Ohio State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: Yael Vodovotz
investigator title: Professor
mesh term: Overweight
mesh term: Metabolic Syndrome
mesh term: Syndrome