<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/NCT03758742</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-300001719</org_study_id>
    <nct_id>NCT03758742</nct_id>
  </id_info>
  <brief_title>Effect of Whole Fruit on Glycemic Control in Adults With Type 2 Diabetes</brief_title>
  <official_title>Effect of Whole Fruit on Glycemic Control in Adults With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diabetes costs the U.S. healthcare system more than any other disease, and nearly half of&#xD;
      Americans will develop either diabetes or prediabetes in their lifetime. It is therefore&#xD;
      critical to find new strategies to treat or reverse diabetes.&#xD;
&#xD;
      One such approach is adopting a healthy diet, which can dramatically improve blood sugar&#xD;
      levels in adults with type 2 diabetes and even induce diabetes remission. Despite this, not&#xD;
      much is known about which food groups are most effective at improving blood sugar levels in&#xD;
      patients with diabetes.&#xD;
&#xD;
      Interestingly, of the various food groups that comprise the Mediterranean diet, epidemiologic&#xD;
      data suggests that whole fruit may be one of the most efficacious at both preventing type 2&#xD;
      diabetes and improving blood sugar in patients with type 2 diabetes. However, few clinical&#xD;
      trials have investigated the effects of whole fruit on blood sugar control. This study will&#xD;
      therefore be the first to determine the effects of increasing whole fruit as a food group in&#xD;
      type 2 diabetes patients. This supervised controlled feeding trial will test whether&#xD;
      consuming a diet rich in whole fruit for 12 weeks can induce diabetes remission and can&#xD;
      improve blood sugar, liver fat, and cardiovascular health in adults with type 2 diabetes.&#xD;
      Thereafter, participants will be followed for up to one year. As a secondary aim, this study&#xD;
      will also test whether consuming a large amount of fructose in whole food form negatively&#xD;
      affects liver fat and cardiovascular health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pre-registration notes: The primary endpoint is glycemic control, which will be analyzed&#xD;
      hierarchically in descending order of importance as:&#xD;
&#xD;
        1. Diabetes remission rate (endpoint #1)&#xD;
&#xD;
        2. Medication effect score (endpoint #2)&#xD;
&#xD;
        3. Fasting glucose and HbA1c (endpoints #3-4)&#xD;
&#xD;
        4. Oral glucose tolerance test and continuous glucose monitoring measures (endpoints #5-14)&#xD;
&#xD;
      while the secondary endpoints (endpoints #15-20) will all be evaluated with equal importance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 10, 2019</start_date>
  <completion_date type="Anticipated">June 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>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diabetes remission rate</measure>
    <time_frame>Change from baseline (Week 0) to Weeks 4 and 12 and follow-up Months 6, 9, and 12</time_frame>
    <description>Remission rate will be measured in two ways. At the end of Phase II, it will be quantified as the percentage of patients who achieve non-diabetic levels of fasting glucose without the aid of any anti-hyperglycemic pharmacologic therapy or ongoing procedures.. During the Follow-up period, it will be quantified as the percentage of patients who achieve non-diabetic levels of both fasting glucose and HbA1c without the aid of any anti-hyperglycemic pharmacologic therapy or ongoing procedures.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diabetes medication usage</measure>
    <time_frame>Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12</time_frame>
    <description>As quantified by the Medication Effect Score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fasting glucose</measure>
    <time_frame>Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12</time_frame>
    <description>mg/dl</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HbA1c</measure>
    <time_frame>Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12</time_frame>
    <description>percentage</description>
  </primary_outcome>
  <primary_outcome>
    <measure>2-hour glucose tolerance</measure>
    <time_frame>Change from baseline to Weeks 4 and 12</time_frame>
    <description>mg/dl</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean glucose during a 3-hour Oral Glucose Tolerance Test (OGTT)</measure>
    <time_frame>Change from baseline to Weeks 4 and 12</time_frame>
    <description>mg/dl</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean insulin during a 3-hour OGTT</measure>
    <time_frame>Change from baseline to Weeks 4 and 12</time_frame>
    <description>mU/l</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean C-peptide during a 3-hour OGTT</measure>
    <time_frame>Change from baseline to Weeks 4 and 12</time_frame>
    <description>ng/ml</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fasting insulin</measure>
    <time_frame>Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12</time_frame>
    <description>mU/l</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fasting C-peptide</measure>
    <time_frame>Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12</time_frame>
    <description>ng/ml</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Insulin sensitivity</measure>
    <time_frame>Change from baseline to Weeks 4 and 12</time_frame>
    <description>Insulin sensitivity (dl/kg/min/μU/ml) during a 3-hour OGTT, as measured by the Oral Minimal Model</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Insulin secretion</measure>
    <time_frame>Change from baseline to Weeks 4 and 12</time_frame>
    <description>Beta-cell responsivity index during a 3-hour OGTT, as measured by the Oral Minimal Model</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Beta-cell function</measure>
    <time_frame>Change from baseline to Weeks 4 and 12</time_frame>
    <description>Insulinogenic index as measured during the first 15 minutes of a 3-hour OGTT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean 24-hour glucose levels, peak glucose levels, and mean amplitude of glycemic excursions (MAGE), as measured using continuous glucose monitoring</measure>
    <time_frame>Change from baseline to Weeks 4 and 12</time_frame>
    <description>mg/dl</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intrahepatic lipid (liver fat)</measure>
    <time_frame>Change from baseline to Weeks 4 and 12</time_frame>
    <description>Percentage as measured using Magnetic Resonance Spectroscopy (MRS) and 3-point M-Dixon Magnetic Resonance Imaging (MRI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting lipids</measure>
    <time_frame>Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12</time_frame>
    <description>Total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), and triglycerides (mg/dl)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic and diastolic blood pressure</measure>
    <time_frame>Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12</time_frame>
    <description>mm Hg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12</time_frame>
    <description>beats per minute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of cardiovascular medications used</measure>
    <time_frame>Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12</time_frame>
    <description>Number for each category of medication (e.g., anti-hypertensive medications)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dosage of cardiovascular medications used</measure>
    <time_frame>Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12</time_frame>
    <description>Dosages for each category of medication (e.g., anti-hypertensive medications)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Body weight</measure>
    <time_frame>Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12</time_frame>
    <description>kg</description>
  </other_outcome>
  <other_outcome>
    <measure>Waist circumference</measure>
    <time_frame>Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12</time_frame>
    <description>cm</description>
  </other_outcome>
  <other_outcome>
    <measure>Pancreatic fat</measure>
    <time_frame>Change from baseline to Weeks 4 and 12</time_frame>
    <description>Percentage as measured using MRS and 3-point M-Dixon MRI methods</description>
  </other_outcome>
  <other_outcome>
    <measure>Visceral fat</measure>
    <time_frame>Change from baseline to Weeks 4 and 12</time_frame>
    <description>kg as measured using MRI</description>
  </other_outcome>
  <other_outcome>
    <measure>Subcutaneous abdominal fat</measure>
    <time_frame>Change from baseline to Weeks 4 and 12</time_frame>
    <description>kg as measured using MRI</description>
  </other_outcome>
  <other_outcome>
    <measure>Gut microbiome diversity</measure>
    <time_frame>Change from baseline to Weeks 4 and 12</time_frame>
    <description>Diversity metrics (i.e., alpha and beta diversity)</description>
  </other_outcome>
  <other_outcome>
    <measure>Gut microbiome composition</measure>
    <time_frame>Change from baseline to Weeks 4 and 12</time_frame>
    <description>Taxonomic composition and abundances</description>
  </other_outcome>
  <other_outcome>
    <measure>Transcriptome</measure>
    <time_frame>Change from baseline to Weeks 4 and 12</time_frame>
    <description>Fold change in gene expression within blood cells (includes pathway analyses)</description>
  </other_outcome>
  <other_outcome>
    <measure>Preference and sensitivity to sweet tastes</measure>
    <time_frame>Change from baseline to Weeks 4 and 12</time_frame>
    <description>As measured on a 0-100 mm visual analog scale (VAS), using a Sweetness Taste Test</description>
  </other_outcome>
  <other_outcome>
    <measure>Caloric intake</measure>
    <time_frame>Change from baseline to Week 4 and follow-up Month 12</time_frame>
    <description>kcal/day as measured using 7-day food records</description>
  </other_outcome>
  <other_outcome>
    <measure>Macronutrient composition</measure>
    <time_frame>Change from baseline to Week 4 and follow-up Month 12</time_frame>
    <description>Percentage of calories as measured using 7-day food records</description>
  </other_outcome>
  <other_outcome>
    <measure>Diet satisfaction</measure>
    <time_frame>Change from baseline to Weeks 4 and 12</time_frame>
    <description>As measured on a 0-100 mm visual analog scale (VAS)</description>
  </other_outcome>
  <other_outcome>
    <measure>Food intake</measure>
    <time_frame>Change from baseline to Week 4 and follow-up Month 12</time_frame>
    <description>Percent intake of individual food categories as measured using 7-day food records</description>
  </other_outcome>
  <other_outcome>
    <measure>Habitual fruit consumption</measure>
    <time_frame>Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12</time_frame>
    <description>As estimated using a series of semi-quantitative food frequency questions from the Diet History Questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Food cravings</measure>
    <time_frame>Change from baseline to Weeks 4 and 12</time_frame>
    <description>As measured on five-point scales by the Food Craving Inventory-II</description>
  </other_outcome>
  <other_outcome>
    <measure>Fruit type preferences</measure>
    <time_frame>Change from baseline to Weeks 4 and 12</time_frame>
    <description>As measured by VAS on a 0-100 mm scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Food attitudes and behaviors</measure>
    <time_frame>Change from baseline to Weeks 4 and 12</time_frame>
    <description>As measured by a modified version of the National Cancer Institute (NCI) 2007 Food Attitudes and Behaviors Survey, which covers constructs including attitudes and beliefs, fruit and vegetable consumption, eating behaviors, and food preferences</description>
  </other_outcome>
  <other_outcome>
    <measure>General health status</measure>
    <time_frame>Change from baseline to Weeks 4 and 12</time_frame>
    <description>Healthy days (along various dimensions) as measured by the Centers for Disease Control and Prevention's (CDC) Health-Related Qualify of Life questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Depression</measure>
    <time_frame>Change from baseline to Weeks 4 and 12</time_frame>
    <description>As measured on a 0-27 point scale by the Patient Health Questionnaire-9</description>
  </other_outcome>
  <other_outcome>
    <measure>Mood states</measure>
    <time_frame>Change from baseline to Weeks 4 and 12</time_frame>
    <description>As measured on a 5-point scale by the Profile of Mood States Short-Form</description>
  </other_outcome>
  <other_outcome>
    <measure>Intervention satisfaction and feedback</measure>
    <time_frame>Week 12</time_frame>
    <description>As measured by qualitative exit interview</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">21</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>High-Fruit Diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>High-Fruit Diet</intervention_name>
    <description>Participants will consume a diet rich in whole fruit. During Phase I (Weeks 1-4; supervised controlled feeding), participants will gradually increase the amount of whole fruit they consume, eventually reaching 50% of calories from whole fruit. In Phase II (Week 5-12; supervised controlled feeding), participants will consume a whole fruit-rich, eucaloric diet that provides 50% of calories in the form of whole fruit. The non-fruit portion of the diet will be styled as a Mediterranean Diet. Participants will be required to approximately keep their weight stable during Phases I and II. In the Follow-Up Phase (Months 4-12; free-living), participants will be instructed to continue consuming at least one-third of their diet as whole fruit and to make healthy food choices.</description>
    <arm_group_label>High-Fruit Diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  20-65 years old&#xD;
&#xD;
          -  BMI between 27.0-45.0 kg/m^2&#xD;
&#xD;
          -  First diagnosed with type 2 diabetes within the past 6 years&#xD;
&#xD;
          -  HbA1c between 6.0-9.5%%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  On insulin&#xD;
&#xD;
          -  Diagnosis of diabetes before age 18&#xD;
&#xD;
          -  Estimated glomerular filtration rate &lt; 45 ml/min per 1.732 m^2&#xD;
&#xD;
          -  Heart attack in the past 6 months or severe or unstable heart failure&#xD;
&#xD;
          -  On weight loss medication&#xD;
&#xD;
          -  Change in the dosage of a chronic medication that may affect study endpoints within&#xD;
             the past 3 months&#xD;
&#xD;
          -  Clinically significant laboratory abnormality (e.g. abnormal hemoglobin levels)&#xD;
&#xD;
          -  Significant gastrointestinal disease, major gastrointestinal surgery, or gallstones&#xD;
&#xD;
          -  Significant cardiovascular, renal, cardiac, liver, lung, adrenal, or nervous system&#xD;
             disease that might compromise safety or data validity&#xD;
&#xD;
          -  Evidence of cancer (other than non-melanoma skin cancer) within the last 5 years&#xD;
&#xD;
          -  Lost or gained more than 5 kg of weight in the past 6 months&#xD;
&#xD;
          -  Pregnant, planning to become pregnant in the next 12 months, or breastfeeding&#xD;
&#xD;
          -  Major psychiatric condition that would affect the ability to participate in the study&#xD;
&#xD;
          -  Not able to eat the provided study meals&#xD;
&#xD;
          -  Behavioral factors or circumstances that may impede adhering to the dietary&#xD;
             intervention&#xD;
&#xD;
          -  Not able to do the MRI/MRS abdominal scan, such as due to claustrophobia, implanted&#xD;
             metal objects, or a body girth of 60 cm or greater&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Courtney M. Peterson, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Courtney M. Peterson, Ph.D.</last_name>
    <phone>205-934-0122</phone>
    <email>cpeterso@uab.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Cody J. Hanick, M.S.</last_name>
    <phone>205-934-5458</phone>
    <email>chanick@uab.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Nutrition Sciences, University of Alabamam at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Courtney Peterson, Ph.D.</last_name>
      <phone>205-934-0122</phone>
      <email>cpeterso@uab.edu</email>
    </contact>
    <contact_backup>
      <last_name>Cody Hanick, M.S.</last_name>
      <phone>(262) 923-0672</phone>
      <email>chanick@uab.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Courtney Peterson, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Cody Hanick, M.S.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>June 30, 2023</last_update_submitted>
  <last_update_submitted_qc>June 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Courtney M Peterson</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>diabetes</keyword>
  <keyword>whole fruit</keyword>
  <keyword>diabetes remission</keyword>
  <keyword>glycemic control</keyword>
  <keyword>liver fat</keyword>
  <keyword>intrahepatic lipid</keyword>
  <keyword>controlled feeding trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT03758742
org study id: IRB-300001719
nct id: NCT03758742
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Diabetes costs the U.S. healthcare system more than any other disease, and nearly half of
      Americans will develop either diabetes or prediabetes in their lifetime. It is therefore
      critical to find new strategies to treat or reverse diabetes.

      One such approach is adopting a healthy diet, which can dramatically improve blood sugar
      levels in adults with type 2 diabetes and even induce diabetes remission. Despite this, not
      much is known about which food groups are most effective at improving blood sugar levels in
      patients with diabetes.

      Interestingly, of the various food groups that comprise the Mediterranean diet, epidemiologic
      data suggests that whole fruit may be one of the most efficacious at both preventing type 2
      diabetes and improving blood sugar in patients with type 2 diabetes. However, few clinical
      trials have investigated the effects of whole fruit on blood sugar control. This study will
      therefore be the first to determine the effects of increasing whole fruit as a food group in
      type 2 diabetes patients. This supervised controlled feeding trial will test whether
      consuming a diet rich in whole fruit for 12 weeks can induce diabetes remission and can
      improve blood sugar, liver fat, and cardiovascular health in adults with type 2 diabetes.
      Thereafter, participants will be followed for up to one year. As a secondary aim, this study
      will also test whether consuming a large amount of fructose in whole food form negatively
      affects liver fat and cardiovascular health.
Pre-registration notes: The primary endpoint is glycemic control, which will be analyzed
      hierarchically in descending order of importance as:

        1. Diabetes remission rate (endpoint #1)

        2. Medication effect score (endpoint #2)

        3. Fasting glucose and HbA1c (endpoints #3-4)

        4. Oral glucose tolerance test and continuous glucose monitoring measures (endpoints #5-14)

      while the secondary endpoints (endpoints #15-20) will all be evaluated with equal importance.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Diabetes remission rate
time frame: Change from baseline (Week 0) to Weeks 4 and 12 and follow-up Months 6, 9, and 12
description: Remission rate will be measured in two ways. At the end of Phase II, it will be quantified as the percentage of patients who achieve non-diabetic levels of fasting glucose without the aid of any anti-hyperglycemic pharmacologic therapy or ongoing procedures.. During the Follow-up period, it will be quantified as the percentage of patients who achieve non-diabetic levels of both fasting glucose and HbA1c without the aid of any anti-hyperglycemic pharmacologic therapy or ongoing procedures.
measure: Diabetes medication usage
time frame: Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12
description: As quantified by the Medication Effect Score
measure: Fasting glucose
time frame: Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12
description: mg/dl
measure: HbA1c
time frame: Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12
description: percentage
measure: 2-hour glucose tolerance
time frame: Change from baseline to Weeks 4 and 12
description: mg/dl
measure: Mean glucose during a 3-hour Oral Glucose Tolerance Test (OGTT)
time frame: Change from baseline to Weeks 4 and 12
description: mg/dl
measure: Mean insulin during a 3-hour OGTT
time frame: Change from baseline to Weeks 4 and 12
description: mU/l
measure: Mean C-peptide during a 3-hour OGTT
time frame: Change from baseline to Weeks 4 and 12
description: ng/ml
measure: Fasting insulin
time frame: Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12
description: mU/l
measure: Fasting C-peptide
time frame: Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12
description: ng/ml
measure: Insulin sensitivity
time frame: Change from baseline to Weeks 4 and 12
description: Insulin sensitivity (dl/kg/min/μU/ml) during a 3-hour OGTT, as measured by the Oral Minimal Model
measure: Insulin secretion
time frame: Change from baseline to Weeks 4 and 12
description: Beta-cell responsivity index during a 3-hour OGTT, as measured by the Oral Minimal Model
measure: Beta-cell function
time frame: Change from baseline to Weeks 4 and 12
description: Insulinogenic index as measured during the first 15 minutes of a 3-hour OGTT
measure: Mean 24-hour glucose levels, peak glucose levels, and mean amplitude of glycemic excursions (MAGE), as measured using continuous glucose monitoring
time frame: Change from baseline to Weeks 4 and 12
description: mg/dl
measure: Intrahepatic lipid (liver fat)
time frame: Change from baseline to Weeks 4 and 12
description: Percentage as measured using Magnetic Resonance Spectroscopy (MRS) and 3-point M-Dixon Magnetic Resonance Imaging (MRI)
measure: Fasting lipids
time frame: Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12
description: Total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), and triglycerides (mg/dl)
measure: Systolic and diastolic blood pressure
time frame: Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12
description: mm Hg
measure: Heart rate
time frame: Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12
description: beats per minute
measure: Number of cardiovascular medications used
time frame: Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12
description: Number for each category of medication (e.g., anti-hypertensive medications)
measure: Dosage of cardiovascular medications used
time frame: Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12
description: Dosages for each category of medication (e.g., anti-hypertensive medications)
measure: Body weight
time frame: Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12
description: kg
measure: Waist circumference
time frame: Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12
description: cm
measure: Pancreatic fat
time frame: Change from baseline to Weeks 4 and 12
description: Percentage as measured using MRS and 3-point M-Dixon MRI methods
measure: Visceral fat
time frame: Change from baseline to Weeks 4 and 12
description: kg as measured using MRI
measure: Subcutaneous abdominal fat
time frame: Change from baseline to Weeks 4 and 12
description: kg as measured using MRI
measure: Gut microbiome diversity
time frame: Change from baseline to Weeks 4 and 12
description: Diversity metrics (i.e., alpha and beta diversity)
measure: Gut microbiome composition
time frame: Change from baseline to Weeks 4 and 12
description: Taxonomic composition and abundances
measure: Transcriptome
time frame: Change from baseline to Weeks 4 and 12
description: Fold change in gene expression within blood cells (includes pathway analyses)
measure: Preference and sensitivity to sweet tastes
time frame: Change from baseline to Weeks 4 and 12
description: As measured on a 0-100 mm visual analog scale (VAS), using a Sweetness Taste Test
measure: Caloric intake
time frame: Change from baseline to Week 4 and follow-up Month 12
description: kcal/day as measured using 7-day food records
measure: Macronutrient composition
time frame: Change from baseline to Week 4 and follow-up Month 12
description: Percentage of calories as measured using 7-day food records
measure: Diet satisfaction
time frame: Change from baseline to Weeks 4 and 12
description: As measured on a 0-100 mm visual analog scale (VAS)
measure: Food intake
time frame: Change from baseline to Week 4 and follow-up Month 12
description: Percent intake of individual food categories as measured using 7-day food records
measure: Habitual fruit consumption
time frame: Change from baseline to Weeks 4 and 12 and follow-up Months 6, 9, and 12
description: As estimated using a series of semi-quantitative food frequency questions from the Diet History Questionnaire
measure: Food cravings
time frame: Change from baseline to Weeks 4 and 12
description: As measured on five-point scales by the Food Craving Inventory-II
measure: Fruit type preferences
time frame: Change from baseline to Weeks 4 and 12
description: As measured by VAS on a 0-100 mm scale
measure: Food attitudes and behaviors
time frame: Change from baseline to Weeks 4 and 12
description: As measured by a modified version of the National Cancer Institute (NCI) 2007 Food Attitudes and Behaviors Survey, which covers constructs including attitudes and beliefs, fruit and vegetable consumption, eating behaviors, and food preferences
measure: General health status
time frame: Change from baseline to Weeks 4 and 12
description: Healthy days (along various dimensions) as measured by the Centers for Disease Control and Prevention's (CDC) Health-Related Qualify of Life questionnaire
measure: Depression
time frame: Change from baseline to Weeks 4 and 12
description: As measured on a 0-27 point scale by the Patient Health Questionnaire-9
measure: Mood states
time frame: Change from baseline to Weeks 4 and 12
description: As measured on a 5-point scale by the Profile of Mood States Short-Form
measure: Intervention satisfaction and feedback
time frame: Week 12
description: As measured by qualitative exit interview
arm group label: High-Fruit Diet
arm group type: Experimental
intervention type: Behavioral
intervention name: High-Fruit Diet
description: Participants will consume a diet rich in whole fruit. During Phase I (Weeks 1-4; supervised controlled feeding), participants will gradually increase the amount of whole fruit they consume, eventually reaching 50% of calories from whole fruit. In Phase II (Week 5-12; supervised controlled feeding), participants will consume a whole fruit-rich, eucaloric diet that provides 50% of calories in the form of whole fruit. The non-fruit portion of the diet will be styled as a Mediterranean Diet. Participants will be required to approximately keep their weight stable during Phases I and II. In the Follow-Up Phase (Months 4-12; free-living), participants will be instructed to continue consuming at least one-third of their diet as whole fruit and to make healthy food choices.
arm group label: High-Fruit Diet
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Courtney M. Peterson, Ph.D.
role: Principal Investigator
affiliation: University of Alabama at Birmingham
last name: Courtney M. Peterson, Ph.D.
phone: 205-934-0122
email: cpeterso@uab.edu
last name: Cody J. Hanick, M.S.
phone: 205-934-5458
email: chanick@uab.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Courtney M Peterson
investigator title: Assistant Professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2