<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/NCT03772067</url>
  </required_header>
  <id_info>
    <org_study_id>0226-17-WOMC</org_study_id>
    <nct_id>NCT03772067</nct_id>
  </id_info>
  <brief_title>Influence of Dairy Protein Breakfast on Glycemia, Weight Loss and Clock Genes in T2D</brief_title>
  <acronym>Mdiet</acronym>
  <official_title>Influence of Dairy Protein Breakfast on Overall Daily Glycemia, Weight Loss HbA1c and Clock Genes mRNA Expression, in Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel Aviv University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Zohar Landau</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shani Tsameret</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Tel Aviv 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>
      This study in T2D patients is undertaken to evaluate the effect of previously studied 3Meals&#xD;
      Diet, high energy breakfast (Bdiet) with milk and dairy proteins (MBdiet) versus isocaloric&#xD;
      diet with same meal distribution but with other sources of protein (OBdiet) overall&#xD;
      postprandial glycemia (PPG), weight loss (WL), HbA1c, CG expression and on PPG, insulin,&#xD;
      C-peptide, GLP-1, gut peptide YY (PYY), cholecystokinin (CCK), ghrelin, dipeptidyl&#xD;
      peptidase-4 plasma activity (DPP-4) and appetite responses after high protein breakfast.&#xD;
      challenge including milk and dairy products (MBdiet) and after breakfast challenge with same&#xD;
      protein content but different source of protein (OBdiet)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Increased circadian glucose excursions and overall postprandial glycemia (PPG) are linked to&#xD;
      HbA1c and cardiovascular risk in T2D.&#xD;
&#xD;
      Most of the metabolic pathways involved in PPG i.e. secretion of insulin and glucagon-like&#xD;
      peptide-1 (GLP-1), are controlled by circadian clock genes (CG). However, the CG regulation&#xD;
      is bidirectional, indeed high protein breakfast (B), by increasing insulin and GLP-1&#xD;
      upregulate CG expression leading to reduced overall PPG, HbA1c and weight loss (WL) in T2D.&#xD;
      Furthermore in recent study the investigators have shown that in type 2 diabetic patient&#xD;
      treated with insulin a diet with 3 Meal Diet consisting in high energy and protein breakfast,&#xD;
      medium sized lunch and low energy dinner, with selective time restriction from carbohydrate&#xD;
      consumption after 15:00, designed as Bdiet; was more effective approach for reduction of&#xD;
      overall PPG, HbA1c and for upregulation of Clock Genes (CG) mRNA expression compared to&#xD;
      isocaloric 6 Meal Diet, with calories and macronutrient evenly distributed along the day in&#xD;
      three main meals and 3 snack in between.&#xD;
&#xD;
      As the beneficial effects of high energy and protein breakfast in 3Meal diet on the reduction&#xD;
      of body weight, overall glycemia and up regulation CG expression, have been demonstrated, in&#xD;
      recent studies, we hypothesized that some sources of protein in the breakfast may exert be&#xD;
      more beneficial than other source of protein on body weight, PPG, HbA1c and on CG expression&#xD;
      Milk consumption is linked to lower risk for obesity and T2D. In acute studies, the addition&#xD;
      of milk to carbohydrates in B, displayed greater lowering effect of glucose response after&#xD;
      breakfast, lunch and dinner compared with other protein sources.&#xD;
&#xD;
      However the effect of a diet 3Mdiet with high energy and dairy protein breakfast (MBdiet), on&#xD;
      overall PPG, weight loss HbA1c, the effect on effect on circadian clock genes and AMPK mRNA&#xD;
      expression and on the postprandial glucose, insulin, C-peptide, GLP-1, PYY, CCK, ghrelin,&#xD;
      DPP4 plasma activity and appetite has never been explored and never were compared to&#xD;
      isocaloric 3Mdiet with other then dairy protein source of protein (OBdiet) in long term study&#xD;
      in T2D individuals .&#xD;
&#xD;
      The investigators hypothesize that a diet with high energy and protein breakfast consisting&#xD;
      on milk and dairy proteins (MBdiet), by enhancing clock gene expression will lead to more&#xD;
      efficient weight loss reduction of overall PPG, and glucose control (HbA1c), compared to a&#xD;
      diet with other (non dairy) proteins in the breakfast (OBdiet). The investigators also&#xD;
      hypothesize that the dairy breakfast effects in MBdiet may be mediated, at least in part, by&#xD;
      integration of events that promote greater postprandial glucose insulin, C-peptide, GLP-1,&#xD;
      PYY, and CCK, and greater suppression of ghrelin appetite and DPP4 plasma activity,&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 28, 2018</start_date>
  <completion_date type="Anticipated">October 20, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 20, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Parallel assignment</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clock genes mRNA expression</measure>
    <time_frame>two weeks</time_frame>
    <description>The effect of the two diets (MBdiet and OBdiet) will be compared on their efficacy on changing the clock genes expression</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Continuous Glucose Monitoring (CGM)</measure>
    <time_frame>two weeks</time_frame>
    <description>The effect of the two diets (MBdiet and OBdiet) will be compared on their efficacy on changing overall glycemia assessed by Continuous Glucose Monitoring (CGM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1c</measure>
    <time_frame>3 months</time_frame>
    <description>The effect of the two diets (MBdiet and OBdiet) will be compared on their efficacy on changing HbA1c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Weight</measure>
    <time_frame>3 months</time_frame>
    <description>The effect of the two diets (MBdiet and OBdiet) will be compared on their efficacy on changing body weight</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Type2 Diabetes</condition>
  <condition>Healthy Obesity, Metabolically</condition>
  <arm_group>
    <arm_group_label>MBdiet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm consist on 3 month on Bdiet with high energy and protein breakfast (660 +/-20 kcal), medium sized lunch (580+/-20 kcal) and dinner reduced in energy (300+/-20 kcal), with distribution of calories: breakfast 44%, lunch 37% and dinner 19%. The breakfast will contain 38 g protein mostly from milk and dairy products.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OBdiet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm consist on 3 month on Bdiet with high energy and protein breakfast (660 +/-20 kcal), medium sized lunch (580+/-20 kcal) and dinner reduced in energy (300+/-20 kcal), with distribution of calories: breakfast 44%, lunch 37% and dinner 19%. The breakfast will 38 g protein without milk or dairy products mostly from other proteins, i.e. eggs, tuna, soy, oatmeal. Milk product will be avoided in this diet also in other meals along the day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Continuous glucose monitoring CGM</intervention_name>
    <description>The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the overall glucose levels measured with CGM installed in the arm during 14 days at baseline before diet intervention and after 14 days of the beginning of diet intervention</description>
    <arm_group_label>MBdiet</arm_group_label>
    <arm_group_label>OBdiet</arm_group_label>
    <other_name>CGM</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Clock Genes m RNA expression</intervention_name>
    <description>The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the blood levels of Clock Genes measured at baseline and after 14 days of diet intervention</description>
    <arm_group_label>MBdiet</arm_group_label>
    <arm_group_label>OBdiet</arm_group_label>
    <other_name>CG</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Postprandial Glucose</intervention_name>
    <description>The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma Glucose measured at meal test after 14 days of diet intervention</description>
    <arm_group_label>MBdiet</arm_group_label>
    <arm_group_label>OBdiet</arm_group_label>
    <other_name>PPG</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Postprandial Insulin</intervention_name>
    <description>The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma Insulin measured at meal test after 14 days of diet intervention</description>
    <arm_group_label>MBdiet</arm_group_label>
    <arm_group_label>OBdiet</arm_group_label>
    <other_name>Insulin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Plasma GLP-1</intervention_name>
    <description>The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma GLP-1 measured at meal test after 14 days of diet intervention</description>
    <arm_group_label>MBdiet</arm_group_label>
    <arm_group_label>OBdiet</arm_group_label>
    <other_name>GLP-1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>DPP4 plasma activity</intervention_name>
    <description>The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial DPP4 plasma activity measured at meal test after 14 days of diet intervention</description>
    <arm_group_label>MBdiet</arm_group_label>
    <arm_group_label>OBdiet</arm_group_label>
    <other_name>DPP4</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Ghrelin</intervention_name>
    <description>The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma Ghrelin measured at meal test after 14 days of diet intervention</description>
    <arm_group_label>MBdiet</arm_group_label>
    <arm_group_label>OBdiet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Plasma CCK</intervention_name>
    <description>The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma CCK measured at meal test after 14 days of diet intervention</description>
    <arm_group_label>MBdiet</arm_group_label>
    <arm_group_label>OBdiet</arm_group_label>
    <other_name>CCK</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Plasma PYY</intervention_name>
    <description>The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma PYY measured at meal test after 14 days of diet intervention</description>
    <arm_group_label>MBdiet</arm_group_label>
    <arm_group_label>OBdiet</arm_group_label>
    <other_name>PYY</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Body Weight</intervention_name>
    <description>The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the body weight at baseline and every weeks of diet intervention</description>
    <arm_group_label>MBdiet</arm_group_label>
    <arm_group_label>OBdiet</arm_group_label>
    <other_name>Weight</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Blood levels of HbA1c</intervention_name>
    <description>The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing blood HbA1c measured at baseline and after 90 days of diet intervention diet intervention</description>
    <arm_group_label>MBdiet</arm_group_label>
    <arm_group_label>OBdiet</arm_group_label>
    <other_name>HbA1c</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with T2D &lt; 20 years;&#xD;
&#xD;
          -  HgA1c ≥ 7.0 %.&#xD;
&#xD;
          -  BMI - 28-40 kg/m2&#xD;
&#xD;
          -  Men and women 30 -75 years of age inclusive.&#xD;
&#xD;
          -  Normal liver, kidney and thyroid functions, negative urinary microalbumin test (urMA)&#xD;
             and estimated glomerular filtration rate (eGFR) &gt; 45 mL/min/1.73 m2.&#xD;
&#xD;
          -  Type 2 diabetes controlled with diet and lifestyle alone or with antidiabetic&#xD;
             treatment other than insulin (i.e. buguanides, sulfonylureas, glinides, SGLT2&#xD;
             inhibitors, DPP4 inhibitors, GLP-1 analogs), with stable doses for at least 3 months&#xD;
             before entering the study.&#xD;
&#xD;
          -  Stable weight (less than 5% change in body weight in last 3 months before the study -&#xD;
             determined by self-reporting or documentation in clinical records).&#xD;
&#xD;
          -  Concomitant medication i.e. antihypertensive, anti-lipidemic, anti-thrombotic drugs&#xD;
             will be allowed also on stable dose for at least 3 months before the beginning of the&#xD;
             trial.&#xD;
&#xD;
          -  Patients that usually wake up between 06:00 and 08:00 and go to sleep between 22:00&#xD;
             and 24:00.&#xD;
&#xD;
          -  Should not have shift work within 6 month of the study and should not have crossed&#xD;
             time zones within 2 weeks of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Type 1 diabetes or secondary forms of diabetes.&#xD;
&#xD;
          -  Patients with latent autoimmune diabetes in adults (LADA).&#xD;
&#xD;
          -  Treatment with insulin.&#xD;
&#xD;
          -  Serum creatinine level &gt;2mg/dl. Renal dysfunction: (estimated glomerular filtration&#xD;
             rate eGFR &lt; 45 mL/min/1.73 m2).&#xD;
&#xD;
          -  Hepatic dysfunction: liver disease or transaminase levels &gt; 2.5-fold above normal.&#xD;
             Major illness with life expectancy &lt; 5 years.&#xD;
&#xD;
          -  Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy&#xD;
             within the previous 5 years (with the exception of basal cell skin cancer). Those&#xD;
             taking psychotropic, anorectic medication, steroid treatment or with illicit drug&#xD;
             abuse or alcoholism within one year prior to study onset. Pregnancy or lactation.&#xD;
             Known hypersensitivity to milk components or lactose intolerance. Night or rotating&#xD;
             shift workers or those who crossed more than 2 time zones during the 2- week period&#xD;
             prior to study onset. No change in medication or nutrition supplements or physical&#xD;
             activity will be made during the study. Not able to give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>DANIELA JAKUBOWICZ, MD</last_name>
    <phone>+972508105552</phone>
    <email>daniela.jak@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Julio Wainstein, MD</last_name>
    <phone>+972506296940</phone>
    <email>vainstein@wolfson.health.gov.il</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Diabetes Unit E. Wolfson Hospital</name>
      <address>
        <city>Holon</city>
        <state>Tel Aviv</state>
        <zip>58100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Daniela Jakubowicz</name>
      <address>
        <city>Holon</city>
        <state>Wolfson Medical Center</state>
        <zip>58100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 8, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>December 10, 2018</last_update_submitted>
  <last_update_submitted_qc>December 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tel Aviv University</investigator_affiliation>
    <investigator_full_name>Daniela Jakubowicz</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Obesity, Metabolically Benign</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin</mesh_term>
    <mesh_term>Insulin, Globin Zinc</mesh_term>
    <mesh_term>Glucagon-Like Peptide 1</mesh_term>
  </intervention_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/NCT03772067
org study id: 0226-17-WOMC
nct id: NCT03772067
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study in T2D patients is undertaken to evaluate the effect of previously studied 3Meals
      Diet, high energy breakfast (Bdiet) with milk and dairy proteins (MBdiet) versus isocaloric
      diet with same meal distribution but with other sources of protein (OBdiet) overall
      postprandial glycemia (PPG), weight loss (WL), HbA1c, CG expression and on PPG, insulin,
      C-peptide, GLP-1, gut peptide YY (PYY), cholecystokinin (CCK), ghrelin, dipeptidyl
      peptidase-4 plasma activity (DPP-4) and appetite responses after high protein breakfast.
      challenge including milk and dairy products (MBdiet) and after breakfast challenge with same
      protein content but different source of protein (OBdiet)
Increased circadian glucose excursions and overall postprandial glycemia (PPG) are linked to
      HbA1c and cardiovascular risk in T2D.

      Most of the metabolic pathways involved in PPG i.e. secretion of insulin and glucagon-like
      peptide-1 (GLP-1), are controlled by circadian clock genes (CG). However, the CG regulation
      is bidirectional, indeed high protein breakfast (B), by increasing insulin and GLP-1
      upregulate CG expression leading to reduced overall PPG, HbA1c and weight loss (WL) in T2D.
      Furthermore in recent study the investigators have shown that in type 2 diabetic patient
      treated with insulin a diet with 3 Meal Diet consisting in high energy and protein breakfast,
      medium sized lunch and low energy dinner, with selective time restriction from carbohydrate
      consumption after 15:00, designed as Bdiet; was more effective approach for reduction of
      overall PPG, HbA1c and for upregulation of Clock Genes (CG) mRNA expression compared to
      isocaloric 6 Meal Diet, with calories and macronutrient evenly distributed along the day in
      three main meals and 3 snack in between.

      As the beneficial effects of high energy and protein breakfast in 3Meal diet on the reduction
      of body weight, overall glycemia and up regulation CG expression, have been demonstrated, in
      recent studies, we hypothesized that some sources of protein in the breakfast may exert be
      more beneficial than other source of protein on body weight, PPG, HbA1c and on CG expression
      Milk consumption is linked to lower risk for obesity and T2D. In acute studies, the addition
      of milk to carbohydrates in B, displayed greater lowering effect of glucose response after
      breakfast, lunch and dinner compared with other protein sources.

      However the effect of a diet 3Mdiet with high energy and dairy protein breakfast (MBdiet), on
      overall PPG, weight loss HbA1c, the effect on effect on circadian clock genes and AMPK mRNA
      expression and on the postprandial glucose, insulin, C-peptide, GLP-1, PYY, CCK, ghrelin,
      DPP4 plasma activity and appetite has never been explored and never were compared to
      isocaloric 3Mdiet with other then dairy protein source of protein (OBdiet) in long term study
      in T2D individuals .

      The investigators hypothesize that a diet with high energy and protein breakfast consisting
      on milk and dairy proteins (MBdiet), by enhancing clock gene expression will lead to more
      efficient weight loss reduction of overall PPG, and glucose control (HbA1c), compared to a
      diet with other (non dairy) proteins in the breakfast (OBdiet). The investigators also
      hypothesize that the dairy breakfast effects in MBdiet may be mediated, at least in part, by
      integration of events that promote greater postprandial glucose insulin, C-peptide, GLP-1,
      PYY, and CCK, and greater suppression of ghrelin appetite and DPP4 plasma activity,
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel assignment
primary purpose: Other
masking: None (Open Label)
measure: Clock genes mRNA expression
time frame: two weeks
description: The effect of the two diets (MBdiet and OBdiet) will be compared on their efficacy on changing the clock genes expression
measure: Continuous Glucose Monitoring (CGM)
time frame: two weeks
description: The effect of the two diets (MBdiet and OBdiet) will be compared on their efficacy on changing overall glycemia assessed by Continuous Glucose Monitoring (CGM)
measure: HbA1c
time frame: 3 months
description: The effect of the two diets (MBdiet and OBdiet) will be compared on their efficacy on changing HbA1c
measure: Body Weight
time frame: 3 months
description: The effect of the two diets (MBdiet and OBdiet) will be compared on their efficacy on changing body weight
arm group label: MBdiet
arm group type: Experimental
description: This arm consist on 3 month on Bdiet with high energy and protein breakfast (660 +/-20 kcal), medium sized lunch (580+/-20 kcal) and dinner reduced in energy (300+/-20 kcal), with distribution of calories: breakfast 44%, lunch 37% and dinner 19%. The breakfast will contain 38 g protein mostly from milk and dairy products.
arm group label: OBdiet
arm group type: Active Comparator
description: This arm consist on 3 month on Bdiet with high energy and protein breakfast (660 +/-20 kcal), medium sized lunch (580+/-20 kcal) and dinner reduced in energy (300+/-20 kcal), with distribution of calories: breakfast 44%, lunch 37% and dinner 19%. The breakfast will 38 g protein without milk or dairy products mostly from other proteins, i.e. eggs, tuna, soy, oatmeal. Milk product will be avoided in this diet also in other meals along the day.
intervention type: Device
intervention name: Continuous glucose monitoring CGM
description: The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the overall glucose levels measured with CGM installed in the arm during 14 days at baseline before diet intervention and after 14 days of the beginning of diet intervention
arm group label: MBdiet
arm group label: OBdiet
other name: CGM
intervention type: Diagnostic Test
intervention name: Clock Genes m RNA expression
description: The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the blood levels of Clock Genes measured at baseline and after 14 days of diet intervention
arm group label: MBdiet
arm group label: OBdiet
other name: CG
intervention type: Diagnostic Test
intervention name: Postprandial Glucose
description: The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma Glucose measured at meal test after 14 days of diet intervention
arm group label: MBdiet
arm group label: OBdiet
other name: PPG
intervention type: Diagnostic Test
intervention name: Postprandial Insulin
description: The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma Insulin measured at meal test after 14 days of diet intervention
arm group label: MBdiet
arm group label: OBdiet
other name: Insulin
intervention type: Diagnostic Test
intervention name: Plasma GLP-1
description: The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma GLP-1 measured at meal test after 14 days of diet intervention
arm group label: MBdiet
arm group label: OBdiet
other name: GLP-1
intervention type: Diagnostic Test
intervention name: DPP4 plasma activity
description: The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial DPP4 plasma activity measured at meal test after 14 days of diet intervention
arm group label: MBdiet
arm group label: OBdiet
other name: DPP4
intervention type: Diagnostic Test
intervention name: Ghrelin
description: The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma Ghrelin measured at meal test after 14 days of diet intervention
arm group label: MBdiet
arm group label: OBdiet
intervention type: Diagnostic Test
intervention name: Plasma CCK
description: The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma CCK measured at meal test after 14 days of diet intervention
arm group label: MBdiet
arm group label: OBdiet
other name: CCK
intervention type: Diagnostic Test
intervention name: Plasma PYY
description: The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma PYY measured at meal test after 14 days of diet intervention
arm group label: MBdiet
arm group label: OBdiet
other name: PYY
intervention type: Other
intervention name: Body Weight
description: The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the body weight at baseline and every weeks of diet intervention
arm group label: MBdiet
arm group label: OBdiet
other name: Weight
intervention type: Diagnostic Test
intervention name: Blood levels of HbA1c
description: The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing blood HbA1c measured at baseline and after 90 days of diet intervention diet intervention
arm group label: MBdiet
arm group label: OBdiet
other name: HbA1c
criteria: 
gender: All
minimum age: 30 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: DANIELA JAKUBOWICZ, MD
phone: +972508105552
email: daniela.jak@gmail.com
last name: Julio Wainstein, MD
phone: +972506296940
email: vainstein@wolfson.health.gov.il
facility: 
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Tel Aviv University
investigator full name: Daniela Jakubowicz
investigator title: Professor
mesh term: Diabetes Mellitus, Type 2
mesh term: Obesity, Metabolically Benign
mesh term: Weight Loss
mesh term: Insulin
mesh term: Insulin, Globin Zinc
mesh term: Glucagon-Like Peptide 1