<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/NCT03227874</url>
  </required_header>
  <id_info>
    <org_study_id>2040097</org_study_id>
    <nct_id>NCT03227874</nct_id>
  </id_info>
  <brief_title>Effects of Dried Apple on Metabolic Responses</brief_title>
  <official_title>Acute Effects of Dried Apple Consumption on Metabolic Responses in Healthy Individuals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>San Diego State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>San Diego State University</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>
      Metabolic syndrome is a combination of metabolic comorbidities associated with obesity, which&#xD;
      include impaired glucose tolerance and regulation, hypertension, dyslipidemia, and increased&#xD;
      cardiovascular disease risk. Metabolic syndrome is highly prevalent with the growing trend of&#xD;
      obesity that characterizes the US, with 34% of adults 20 years of age and older meeting the&#xD;
      criteria. The number of people with diabetes is expected to increase dramatically over the&#xD;
      next decades, coinciding with rising obesity rates in many countries. Recent studies have&#xD;
      highlighted the beneficial effects of apple and apple products in reducing the risk of&#xD;
      chronic disease due to their rich content of fiber, nutrients and various phytochemicals. The&#xD;
      primary objective of the proposed research is to determine the acute effect of consumption of&#xD;
      240 kcal servings of dried apples versus a lowfat/high fiber muffin on blood glucose, serum&#xD;
      insulin, and fullness (satiety). The secondary objective of the proposed research is to&#xD;
      determine the acute effect of consumption of dried apple versus a low-fat muffin on various&#xD;
      cognitive domains. As with any organ, the brain requires nutrients to build and maintain its&#xD;
      structure and function, in order to perform in a harmonious manner and avoid damage from&#xD;
      aging. Epidemiological, clinical and basic research studies suggest protective effects of&#xD;
      several classes of nutrients against cognitive decline and risk of dementia. Twenty five male&#xD;
      and female participants between the ages of 20-45 years with a body mass index (BMI) between&#xD;
      18 and 25 will be recruited to participate in the study at San Diego State University. Each&#xD;
      participant will consume both test foods, the dried apple and muffin, on two separate visits&#xD;
      to the lab at least a week apart. The participants will come to each lab visit after a 10&#xD;
      hour overnight fast. After arriving at the laboratory, the participant's will complete a&#xD;
      cognitive pre-test (Concussion Vital Signs Test Battery) consisting of eight short cognitive&#xD;
      tests on a computer. Next After arriving at the lab, blood samples will be collected from&#xD;
      warmed hands by finger-prick into large (250 microliter) heparinized Natelson tubes to obtain&#xD;
      an ample blood collection for analysis of baseline plasma concentrations of glucose and&#xD;
      insulin. The participants will then be given 5 minutes to consume the test food. Subsequent&#xD;
      finger-prick blood samples will be collected at 15, 30, 45, 60, 90 and 120 minutes. The&#xD;
      participants will also rate their feelings of fullness on a visual scale prior to consumption&#xD;
      of the test food and every 15 minutes for two hours after consumption. After the completion&#xD;
      of the finger-prick blood samples and satiety questionnaires the participants will complete a&#xD;
      cognitive post-test which will be a different version of the cognitive pre-test battery.&#xD;
      Concentrations of glucose will be assessed by a handheld glucose monitor as well as an&#xD;
      enzymatic kit. Insulin will be assessed by ELISA or radioimmunoassay. Differences in all&#xD;
      dependent variables between the trials will be determined using a repeated measures ANOVA and&#xD;
      followed post-hoc when appropriate using paired T-tests to take advantage of the higher&#xD;
      statistical power provided by paired comparisons. Data will be reported as means +/- SD.&#xD;
      Significance will be selected at an alpha level of P &lt; 0.05. These data may be useful as&#xD;
      finding a snack source that produces a lower glycemic response and a greater satiating effect&#xD;
      could be valuable in dietary counseling for blood glucose maintenance. For the cognitive&#xD;
      portion of this research, these data may be useful because there is considerable room for&#xD;
      improvement and for expanding evidence-based knowledge on the link between nutrition and&#xD;
      cognition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Before each trial, subjects will fast for 10 hours. The 10-hour period of fasting is enough&#xD;
      for development of the satiety index methodology. Subjects will be asked to refrain from&#xD;
      caffeine and alcohol consumption, as well as strenuous exercise for the 32 hours prior to&#xD;
      each blood collection. For both trials, participants will report to the lab at the same time&#xD;
      each morning following the overnight fast. The subjects will report to the lab twice at least&#xD;
      a week apart; once for the dried apple (240 kcal) trial and once the muffin (240 kcal) trial.&#xD;
      After arriving at the lab, the participants will complete a cognitive pre-test (Concussion&#xD;
      Vital Signs Test Battery) consisting of eight short cognitive tests on a computer. The&#xD;
      cognitive pre- and post-tests will evaluate the following; verbal memory, visual memory,&#xD;
      psychomotor speed, executive function, cognitive flexibility and reaction time. The&#xD;
      participants will use their dominant hand to take the computerized test (except when&#xD;
      indicated during the testing to use a specific hand during the &quot;Finger Tapping Test&quot;) and&#xD;
      will be asked to place their hand at the center of the space bar and keep their hand there&#xD;
      during the cognitive testing. Participant's compliance and behaviors will be observed and&#xD;
      noted by a research assistant. Next blood samples will be collected from warmed hands by&#xD;
      finger-prick into large (250 microliter) heparinized Natelson tubes to obtain an ample blood&#xD;
      collection for analysis of baseline plasma concentrations of glucose and insulin. Following&#xD;
      baseline blood collection, subjects will rank their level of satiety and then consume the&#xD;
      dried apple in their first visit to the lab and the muffin in their second visit to the lab.&#xD;
      Subsequent blood samples and satiety ratings will be collected 15, 30, 45, 60, 90 and 120&#xD;
      minutes following the beginning of food consumption. Wash-out periods of at least a week&#xD;
      between trials will allow for unbiased satiety index reporting by subjects. The satiety index&#xD;
      of dried apple and muffin will be determined. Subjects will rate satiety on a 100 mm 7-point&#xD;
      visual scale. Subjects will rank their level of satiety at any point along the scale.&#xD;
      Participants will complete rankings on the scale prior to test food consumption and every 15&#xD;
      minutes after test food consumption. Participants will not have access to previously marked&#xD;
      scales throughout the testing period. The developers of the satiety index have demonstrated&#xD;
      that this scale provides greater retest reproducibility than a simple visual analog scale.&#xD;
      Immediately after test food consumption, time required for food consumption will be recorded.&#xD;
      Participants will answer the following questions using 100 mm visual analog scales (scale&#xD;
      anchors indicated in parentheses). 1. How much did you like the meal? (0=Dislike extremely,&#xD;
      100=Like extremely) 2. How difficult was the food to eat? (0=Not at all difficult,&#xD;
      100=Extremely difficult) 3. Was the serving size sufficient? (0=Not at all enough, 100=Far&#xD;
      too much) 4. How much more of this food would you like to eat? (0=Nothing at all, 100 A large&#xD;
      amount) 5. Do you feel like eating something else? (0=Nothing at all, 100=A whole meal) 6.&#xD;
      How much more food would you need to eat to completely satisfy your hunger? (0=Nothing at&#xD;
      all, 100=A large amount) 7. Do you feel like eating something sweet (0=Not at all sweet,&#xD;
      100=Very sweet) 8. Do you feel like eating something salty (0=Not at all salty, 100=Very&#xD;
      salty) 9. Do you feel like eating something savory (0=Not at all savory, 100=Very savory).&#xD;
      Subjects will listen to a standardized playlist of music in between tests. Finally after the&#xD;
      blood samples a satiety ratings are completed the participants will have a 10 minute break&#xD;
      and then complete the cognitive post-test (Concussion Vital Signs Test Battery). The&#xD;
      post-test will be a different version of the pre-test but the eight tests will remain in the&#xD;
      same order for consistency. Prior to initiation of the study, an ample supply of dried apple&#xD;
      and muffin will be obtained for the entire study. Collected blood will be centrifuged at 4°C&#xD;
      to obtain plasma. Plasma will be stored in cryogenic vials at -70°C for batch analysis.&#xD;
      Plasma glucose and insulin will be assessed at each time point. Glucose will be analyzed&#xD;
      colorimetrically with kits from Stanbio Laboratory (Boerne, TX). Insulin will be determined&#xD;
      using a radioimmunoassay from Diagnostics Products Corporation (Los Angeles, CA). The area&#xD;
      under the glycemic response curve for the dried apple and muffin will be expressed relative&#xD;
      to the mean response to glucose. Results will be reported as mean ± standard error of mean.&#xD;
      Satiety index will be calculated as previously described as a measure of area under the curve&#xD;
      for dried apple relative to muffin. Statistical analyses will be conducted using the&#xD;
      Statistics Program for Social Sciences (SPSS) computer software package. Differences in&#xD;
      glycemic index, satiety index, answers to visual analog scales, cognitive test scores and&#xD;
      areas under the curve for biochemical parameters between different food trials will be&#xD;
      determined using paired T-tests. Differences in other variables will be assessed with&#xD;
      repeated measures ANOVAs and post-hoc paired T-tests as appropriate to take advantage of the&#xD;
      higher statistical power provided by paired comparisons. Significance will be selected at an&#xD;
      alpha level of P&lt;0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 23, 2015</start_date>
  <completion_date type="Actual">January 29, 2016</completion_date>
  <primary_completion_date type="Actual">November 6, 2015</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>blood glucose response</measure>
    <time_frame>Changes from 0 to 120 minutes after consumption of test food</time_frame>
    <description>blood glucose using reagent</description>
  </primary_outcome>
  <primary_outcome>
    <measure>serum insulin response</measure>
    <time_frame>Changes from 0 to 120 minutes after consumption of test food</time_frame>
    <description>serum insulin using ELISA</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>various cognitive domains</measure>
    <time_frame>baseline and two hour after test food consumption</time_frame>
    <description>concussion vital signs test battery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satiety</measure>
    <time_frame>Changes from 0 to 120 minutes after consumption of test food</time_frame>
    <description>Satiety using 100 mm 7 point visual scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Healthy Individual</condition>
  <arm_group>
    <arm_group_label>Dried apple</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>diced dried apple with 55 g carbohydrate, was consumed by the participants with 220 ml of water.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Muffin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>two muffins, each with 55 g carbohydrate, was consumed by the participants with 220 ml of water.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Dried apple</intervention_name>
    <description>diced dried apple with 55 g carbohydrate, was consumed by the participants with 220 ml of water.</description>
    <arm_group_label>Dried apple</arm_group_label>
    <arm_group_label>Muffin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Muffin</intervention_name>
    <description>two muffins with 55 g carbohydrate, was consumed by the participants with 220 ml of water.</description>
    <arm_group_label>Dried apple</arm_group_label>
    <arm_group_label>Muffin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 20-45 years&#xD;
&#xD;
          -  body mass index (BMI; in kg/m2): 18-25.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  past head injuries,&#xD;
&#xD;
          -  cigarette smoking,&#xD;
&#xD;
          -  pregnancy,&#xD;
&#xD;
          -  allergies to test foods,&#xD;
&#xD;
          -  chronic use of medications known to affect metabolism,&#xD;
&#xD;
          -  presence of any disorder or medications affecting metabolism (e.g., diabetes,&#xD;
             hyperthyroidism, phenylketonuria, obesity, glycogen storage diseases, etc.).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>San Diego State Univeristy</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92182</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 19, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>July 21, 2017</last_update_submitted>
  <last_update_submitted_qc>July 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>San Diego State University</investigator_affiliation>
    <investigator_full_name>Dr. Shirin Hooshmand</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <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/NCT03227874
org study id: 2040097
nct id: NCT03227874
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Metabolic syndrome is a combination of metabolic comorbidities associated with obesity, which
      include impaired glucose tolerance and regulation, hypertension, dyslipidemia, and increased
      cardiovascular disease risk. Metabolic syndrome is highly prevalent with the growing trend of
      obesity that characterizes the US, with 34% of adults 20 years of age and older meeting the
      criteria. The number of people with diabetes is expected to increase dramatically over the
      next decades, coinciding with rising obesity rates in many countries. Recent studies have
      highlighted the beneficial effects of apple and apple products in reducing the risk of
      chronic disease due to their rich content of fiber, nutrients and various phytochemicals. The
      primary objective of the proposed research is to determine the acute effect of consumption of
      240 kcal servings of dried apples versus a lowfat/high fiber muffin on blood glucose, serum
      insulin, and fullness (satiety). The secondary objective of the proposed research is to
      determine the acute effect of consumption of dried apple versus a low-fat muffin on various
      cognitive domains. As with any organ, the brain requires nutrients to build and maintain its
      structure and function, in order to perform in a harmonious manner and avoid damage from
      aging. Epidemiological, clinical and basic research studies suggest protective effects of
      several classes of nutrients against cognitive decline and risk of dementia. Twenty five male
      and female participants between the ages of 20-45 years with a body mass index (BMI) between
      18 and 25 will be recruited to participate in the study at San Diego State University. Each
      participant will consume both test foods, the dried apple and muffin, on two separate visits
      to the lab at least a week apart. The participants will come to each lab visit after a 10
      hour overnight fast. After arriving at the laboratory, the participant's will complete a
      cognitive pre-test (Concussion Vital Signs Test Battery) consisting of eight short cognitive
      tests on a computer. Next After arriving at the lab, blood samples will be collected from
      warmed hands by finger-prick into large (250 microliter) heparinized Natelson tubes to obtain
      an ample blood collection for analysis of baseline plasma concentrations of glucose and
      insulin. The participants will then be given 5 minutes to consume the test food. Subsequent
      finger-prick blood samples will be collected at 15, 30, 45, 60, 90 and 120 minutes. The
      participants will also rate their feelings of fullness on a visual scale prior to consumption
      of the test food and every 15 minutes for two hours after consumption. After the completion
      of the finger-prick blood samples and satiety questionnaires the participants will complete a
      cognitive post-test which will be a different version of the cognitive pre-test battery.
      Concentrations of glucose will be assessed by a handheld glucose monitor as well as an
      enzymatic kit. Insulin will be assessed by ELISA or radioimmunoassay. Differences in all
      dependent variables between the trials will be determined using a repeated measures ANOVA and
      followed post-hoc when appropriate using paired T-tests to take advantage of the higher
      statistical power provided by paired comparisons. Data will be reported as means +/- SD.
      Significance will be selected at an alpha level of P < 0.05. These data may be useful as
      finding a snack source that produces a lower glycemic response and a greater satiating effect
      could be valuable in dietary counseling for blood glucose maintenance. For the cognitive
      portion of this research, these data may be useful because there is considerable room for
      improvement and for expanding evidence-based knowledge on the link between nutrition and
      cognition.
Before each trial, subjects will fast for 10 hours. The 10-hour period of fasting is enough
      for development of the satiety index methodology. Subjects will be asked to refrain from
      caffeine and alcohol consumption, as well as strenuous exercise for the 32 hours prior to
      each blood collection. For both trials, participants will report to the lab at the same time
      each morning following the overnight fast. The subjects will report to the lab twice at least
      a week apart; once for the dried apple (240 kcal) trial and once the muffin (240 kcal) trial.
      After arriving at the lab, the participants will complete a cognitive pre-test (Concussion
      Vital Signs Test Battery) consisting of eight short cognitive tests on a computer. The
      cognitive pre- and post-tests will evaluate the following; verbal memory, visual memory,
      psychomotor speed, executive function, cognitive flexibility and reaction time. The
      participants will use their dominant hand to take the computerized test (except when
      indicated during the testing to use a specific hand during the "Finger Tapping Test") and
      will be asked to place their hand at the center of the space bar and keep their hand there
      during the cognitive testing. Participant's compliance and behaviors will be observed and
      noted by a research assistant. Next blood samples will be collected from warmed hands by
      finger-prick into large (250 microliter) heparinized Natelson tubes to obtain an ample blood
      collection for analysis of baseline plasma concentrations of glucose and insulin. Following
      baseline blood collection, subjects will rank their level of satiety and then consume the
      dried apple in their first visit to the lab and the muffin in their second visit to the lab.
      Subsequent blood samples and satiety ratings will be collected 15, 30, 45, 60, 90 and 120
      minutes following the beginning of food consumption. Wash-out periods of at least a week
      between trials will allow for unbiased satiety index reporting by subjects. The satiety index
      of dried apple and muffin will be determined. Subjects will rate satiety on a 100 mm 7-point
      visual scale. Subjects will rank their level of satiety at any point along the scale.
      Participants will complete rankings on the scale prior to test food consumption and every 15
      minutes after test food consumption. Participants will not have access to previously marked
      scales throughout the testing period. The developers of the satiety index have demonstrated
      that this scale provides greater retest reproducibility than a simple visual analog scale.
      Immediately after test food consumption, time required for food consumption will be recorded.
      Participants will answer the following questions using 100 mm visual analog scales (scale
      anchors indicated in parentheses). 1. How much did you like the meal? (0=Dislike extremely,
      100=Like extremely) 2. How difficult was the food to eat? (0=Not at all difficult,
      100=Extremely difficult) 3. Was the serving size sufficient? (0=Not at all enough, 100=Far
      too much) 4. How much more of this food would you like to eat? (0=Nothing at all, 100 A large
      amount) 5. Do you feel like eating something else? (0=Nothing at all, 100=A whole meal) 6.
      How much more food would you need to eat to completely satisfy your hunger? (0=Nothing at
      all, 100=A large amount) 7. Do you feel like eating something sweet (0=Not at all sweet,
      100=Very sweet) 8. Do you feel like eating something salty (0=Not at all salty, 100=Very
      salty) 9. Do you feel like eating something savory (0=Not at all savory, 100=Very savory).
      Subjects will listen to a standardized playlist of music in between tests. Finally after the
      blood samples a satiety ratings are completed the participants will have a 10 minute break
      and then complete the cognitive post-test (Concussion Vital Signs Test Battery). The
      post-test will be a different version of the pre-test but the eight tests will remain in the
      same order for consistency. Prior to initiation of the study, an ample supply of dried apple
      and muffin will be obtained for the entire study. Collected blood will be centrifuged at 4°C
      to obtain plasma. Plasma will be stored in cryogenic vials at -70°C for batch analysis.
      Plasma glucose and insulin will be assessed at each time point. Glucose will be analyzed
      colorimetrically with kits from Stanbio Laboratory (Boerne, TX). Insulin will be determined
      using a radioimmunoassay from Diagnostics Products Corporation (Los Angeles, CA). The area
      under the glycemic response curve for the dried apple and muffin will be expressed relative
      to the mean response to glucose. Results will be reported as mean ± standard error of mean.
      Satiety index will be calculated as previously described as a measure of area under the curve
      for dried apple relative to muffin. Statistical analyses will be conducted using the
      Statistics Program for Social Sciences (SPSS) computer software package. Differences in
      glycemic index, satiety index, answers to visual analog scales, cognitive test scores and
      areas under the curve for biochemical parameters between different food trials will be
      determined using paired T-tests. Differences in other variables will be assessed with
      repeated measures ANOVAs and post-hoc paired T-tests as appropriate to take advantage of the
      higher statistical power provided by paired comparisons. Significance will be selected at an
      alpha level of P<0.05.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: blood glucose response
time frame: Changes from 0 to 120 minutes after consumption of test food
description: blood glucose using reagent
measure: serum insulin response
time frame: Changes from 0 to 120 minutes after consumption of test food
description: serum insulin using ELISA
measure: various cognitive domains
time frame: baseline and two hour after test food consumption
description: concussion vital signs test battery
measure: Satiety
time frame: Changes from 0 to 120 minutes after consumption of test food
description: Satiety using 100 mm 7 point visual scale
arm group label: Dried apple
arm group type: Experimental
description: diced dried apple with 55 g carbohydrate, was consumed by the participants with 220 ml of water.
arm group label: Muffin
arm group type: Experimental
description: two muffins, each with 55 g carbohydrate, was consumed by the participants with 220 ml of water.
intervention type: Dietary Supplement
intervention name: Dried apple
description: diced dried apple with 55 g carbohydrate, was consumed by the participants with 220 ml of water.
arm group label: Dried apple
arm group label: Muffin
intervention type: Dietary Supplement
intervention name: Muffin
description: two muffins with 55 g carbohydrate, was consumed by the participants with 220 ml of water.
arm group label: Dried apple
arm group label: Muffin
criteria: 
gender: All
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: San Diego State University
investigator full name: Dr. Shirin Hooshmand
investigator title: Associate professor
sharing ipd: No