<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/NCT02984540</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00029992</org_study_id>
    <nct_id>NCT02984540</nct_id>
  </id_info>
  <brief_title>Effect of a Modified Ketogenic-Mediterranean Diet on Alzheimer's Disease</brief_title>
  <acronym>BEAM</acronym>
  <official_title>Effect of a Modified Ketogenic-Mediterranean Diet on Alzheimer's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>Yes</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 BEAM study is to compare the effects of a low-carbohydrate diet and a&#xD;
      lowfat diet for adults with mild memory loss and adults with pre-diabetes. The data collected&#xD;
      will help determine changes in cognitive function, brain structure and function, and levels&#xD;
      of certain proteins and hormones in body fluids.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be enrolled into 1 of 3 study groups. Group 1 will include healthy&#xD;
      volunteers with no apparent memory problems, memory complaints or family history of&#xD;
      Alzheimer's disease or dementia. This group will complete cognitive assessments, blood and&#xD;
      stool sample collection, neuroimaging, and lumbar puncture at week 0 only. Group 1 will NOT&#xD;
      take part in the diet study.&#xD;
&#xD;
      Group 2 will have pre-diabetes, but no apparent memory problems that can be observed during&#xD;
      cognitive testing. Group 2 will complete an 18-week diet study, with follow-up assessment 6&#xD;
      weeks after final diet completion. Throughout the study the following will also be completed;&#xD;
      cognitive assessments, blood and stool sample collection, neuroimaging, and lumbar puncture.&#xD;
&#xD;
      Group 3 will have mild memory problems that are observed during cognitive testing. Group 3&#xD;
      will complete an 18-week diet study, with follow-up assessment 6 weeks after diet final&#xD;
      completion. Throughout the study the following will also be completed; cognitive assessments,&#xD;
      blood and stool sample collection, neuroimaging, and lumbar puncture.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2015</start_date>
  <completion_date type="Actual">April 3, 2017</completion_date>
  <primary_completion_date type="Actual">April 3, 2017</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in spinal fluid levels of biomarkers associated with Alzheimer's disease</measure>
    <time_frame>Baseline CSF measures will be compared to measures obtained six weeks after the initiation of the ketogenic diet and six weeks after initiation of the American Heart Association Diet</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in memory composite score</measure>
    <time_frame>Baseline cognitive measures will be compared to measures obtained six weeks after the initiation of the ketogenic diet and six weeks after initiation of the American Heart Association Diet</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in insulin sensitivity</measure>
    <time_frame>Baseline metabolic measures will be compared to measures obtained six weeks after the initiation of the ketogenic diet and six weeks after initiation of the American Heart Association Diet</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in 11C acetoacetate PET uptake</measure>
    <time_frame>Baseline acetoacetate uptake will be compared to measures obtained six weeks after the initiation of the ketogenic diet and six weeks after initiation of the American Heart Association Diet</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Mild Cognitive Impairment</condition>
  <condition>Insulin Resistance</condition>
  <arm_group>
    <arm_group_label>LOW-CARBOHYDRATE DIET</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The low-carbohydrate diet will consist of a meal plan of less than 20 grams of carbohydrates per day to be consumed over 6 weeks. Foods that provide high levels of healthy fats (preferably low in saturated fats) will be generously included in the diet plan. Various lean meats, fish, and nutrient rich foods that meet the requirement of less than 20 grams total carbohydrates per day will be included in the meal plans. Carbohydrates will be expected to make up less than 10% of total caloric intake. Participants in the low-carbohydrate diet group will receive a supply of extra virgin olive oil at study visits to incorporate into their individualized meal plans.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LOW-FAT DIET</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The low-fat diet will consist of a low-fat, higher-carbohydrate meal plan to be consumed over 6 weeks. Participants will be encouraged to limit their amount of fat intake to less than 40 grams per day, while eating plentiful fruits, vegetables, and carbohydrates containing adequate fiber. Various lean meats and other sources of protein will be included in the diet plan. Carbohydrates will be expected to make up 50-60% of total caloric intake.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low-Carbohydrate Diet</intervention_name>
    <description>Participants assigned to the Modified Ketogenic-Mediterranean Diet will keep their carbohydrate consumption below 20 grams per day throughout the 6-week intervention.</description>
    <arm_group_label>LOW-CARBOHYDRATE DIET</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low-Fat Diet</intervention_name>
    <description>Participants assigned to the Low-Fat Diet will be encouraged to limit their amount of fat intake to &lt;40 grams/day, while eating plentiful fruits, vegetables, and carbohydrates containing adequate fiber.</description>
    <arm_group_label>LOW-FAT DIET</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or post-menopausal female;&#xD;
&#xD;
          2. Age 50 to 85 years inclusive;&#xD;
&#xD;
          3. Cognitive diagnosis ranged from cognitively normal for &quot;'Healthy' and 'At-Risk'&quot; to&#xD;
             mild/moderate cognitive impairment for &quot;MCI/eAD;&quot;&#xD;
&#xD;
          4. Stable medical condition (generally 3 months prior to screening visit) at the&#xD;
             discretion of study physician;&#xD;
&#xD;
          5. Stable on medications (generally 4 weeks prior to screening visit) at the discretion&#xD;
             of study physician;&#xD;
&#xD;
          6. Able to complete baseline assessments;&#xD;
&#xD;
          7. HbA1c and fasting glucose within the normal (Healthy or MCI/eAD) or pre-diabetic&#xD;
             (At-Risk or MCI/eAD) range depending on group.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of neurodegenerative illness (except for MCI or early AD in the MCI/eAD&#xD;
             group);&#xD;
&#xD;
          2. History of a clinically significant stroke;&#xD;
&#xD;
          3. Current evidence or history in past year of focal brain lesion, head injury with loss&#xD;
             of consciousness or DSM-IV criteria for any major psychiatric disorder including&#xD;
             psychosis, major depression, bipolar disorder, alcohol or substance abuse;&#xD;
&#xD;
          4. Sensory impairment (i.e.: visual or auditory) that would preclude the participant from&#xD;
             participating in the protocol;&#xD;
&#xD;
          5. Diabetes that requires current use of diabetes medications;&#xD;
&#xD;
          6. Current use of cholesterol/lipid lowering medications;&#xD;
&#xD;
          7. Clinically significant elevations in liver function tests;&#xD;
&#xD;
          8. Active neoplastic disease (stable prostate cancer and non-melanoma skin cancer is&#xD;
             permissible);&#xD;
&#xD;
          9. History of epilepsy or seizure within past year;&#xD;
&#xD;
         10. Contraindications for MRI (claustrophobia, craniofacial metal implants, pacemakers);&#xD;
&#xD;
         11. Significant medical illness or organ failure, such as uncontrolled hypertension or&#xD;
             cardiovascular disease, chronic obstructive pulmonary disease, liver disease, or&#xD;
             kidney disease;&#xD;
&#xD;
         12. Use of the following medications: anticonvulsants, drugs with potential interfering&#xD;
             CNS effects (other than cholinesterase inhibitors or memantine), medications with&#xD;
             significant anticholinergic activity, anti-parkinsonian medications or regular use of&#xD;
             narcotic analgesics;&#xD;
&#xD;
         13. If female, menstruation in the past 12 months or hysterectomy and current hormone&#xD;
             replacement therapy medication;&#xD;
&#xD;
         14. Major digestive disorders, absorption issues, or surgeries that may be exacerbated by&#xD;
             diet changes;&#xD;
&#xD;
         15. Untreated hypothyroidism or B12 deficiency;&#xD;
&#xD;
         16. Participants currently using resveratrol, CoQ10 (coenzyme Q10), coconut oil/other&#xD;
             medium chain triglyceride-containing (ie: Axona) supplements, or curcumin will be&#xD;
             excluded unless they are willing to discontinue them 2 weeks prior to the start of&#xD;
             baseline visits and remain off for study duration.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suzanne Craft, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wake Forest Baptist Health</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>July 31, 2020</last_update_submitted>
  <last_update_submitted_qc>July 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Insulin Resistance</mesh_term>
    <mesh_term>Cognitive Dysfunction</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/NCT02984540
org study id: IRB00029992
nct id: NCT02984540
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of the BEAM study is to compare the effects of a low-carbohydrate diet and a
      lowfat diet for adults with mild memory loss and adults with pre-diabetes. The data collected
      will help determine changes in cognitive function, brain structure and function, and levels
      of certain proteins and hormones in body fluids.
Participants will be enrolled into 1 of 3 study groups. Group 1 will include healthy
      volunteers with no apparent memory problems, memory complaints or family history of
      Alzheimer's disease or dementia. This group will complete cognitive assessments, blood and
      stool sample collection, neuroimaging, and lumbar puncture at week 0 only. Group 1 will NOT
      take part in the diet study.

      Group 2 will have pre-diabetes, but no apparent memory problems that can be observed during
      cognitive testing. Group 2 will complete an 18-week diet study, with follow-up assessment 6
      weeks after final diet completion. Throughout the study the following will also be completed;
      cognitive assessments, blood and stool sample collection, neuroimaging, and lumbar puncture.

      Group 3 will have mild memory problems that are observed during cognitive testing. Group 3
      will complete an 18-week diet study, with follow-up assessment 6 weeks after diet final
      completion. Throughout the study the following will also be completed; cognitive assessments,
      blood and stool sample collection, neuroimaging, and lumbar puncture.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in spinal fluid levels of biomarkers associated with Alzheimer's disease
time frame: Baseline CSF measures will be compared to measures obtained six weeks after the initiation of the ketogenic diet and six weeks after initiation of the American Heart Association Diet
measure: Change in memory composite score
time frame: Baseline cognitive measures will be compared to measures obtained six weeks after the initiation of the ketogenic diet and six weeks after initiation of the American Heart Association Diet
measure: Change in insulin sensitivity
time frame: Baseline metabolic measures will be compared to measures obtained six weeks after the initiation of the ketogenic diet and six weeks after initiation of the American Heart Association Diet
measure: change in 11C acetoacetate PET uptake
time frame: Baseline acetoacetate uptake will be compared to measures obtained six weeks after the initiation of the ketogenic diet and six weeks after initiation of the American Heart Association Diet
arm group label: LOW-CARBOHYDRATE DIET
arm group type: Experimental
description: The low-carbohydrate diet will consist of a meal plan of less than 20 grams of carbohydrates per day to be consumed over 6 weeks. Foods that provide high levels of healthy fats (preferably low in saturated fats) will be generously included in the diet plan. Various lean meats, fish, and nutrient rich foods that meet the requirement of less than 20 grams total carbohydrates per day will be included in the meal plans. Carbohydrates will be expected to make up less than 10% of total caloric intake. Participants in the low-carbohydrate diet group will receive a supply of extra virgin olive oil at study visits to incorporate into their individualized meal plans.
arm group label: LOW-FAT DIET
arm group type: Experimental
description: The low-fat diet will consist of a low-fat, higher-carbohydrate meal plan to be consumed over 6 weeks. Participants will be encouraged to limit their amount of fat intake to less than 40 grams per day, while eating plentiful fruits, vegetables, and carbohydrates containing adequate fiber. Various lean meats and other sources of protein will be included in the diet plan. Carbohydrates will be expected to make up 50-60% of total caloric intake.
intervention type: Other
intervention name: Low-Carbohydrate Diet
description: Participants assigned to the Modified Ketogenic-Mediterranean Diet will keep their carbohydrate consumption below 20 grams per day throughout the 6-week intervention.
arm group label: LOW-CARBOHYDRATE DIET
intervention type: Other
intervention name: Low-Fat Diet
description: Participants assigned to the Low-Fat Diet will be encouraged to limit their amount of fat intake to <40 grams/day, while eating plentiful fruits, vegetables, and carbohydrates containing adequate fiber.
arm group label: LOW-FAT DIET
criteria: 
gender: All
minimum age: 50 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Suzanne Craft, PhD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Insulin Resistance
mesh term: Cognitive Dysfunction
sharing ipd: No