<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/NCT02248272</url>
  </required_header>
  <id_info>
    <org_study_id>8062</org_study_id>
    <secondary_id>HUA</secondary_id>
    <nct_id>NCT02248272</nct_id>
  </id_info>
  <brief_title>Effect of Meal Frequency on Glycemic Control of People at High Risk or Diagnosed With Diabetes</brief_title>
  <official_title>The Effects of Meal Frequency on Glucose, Insulin, and Insulin Sensitivity in Women With Polycystic Ovary Syndrome (PCOS), People at High Risk for Developing Type 2 Diabetes and People With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meropi Kontogianni</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Agricultural University of Athens</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National and Kapodistrian University of Athens</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Harokopio University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study investigated any potential associations between two isocaloric diets with&#xD;
      different meal frequency (3 meals versus 6 meals) and glycemic control in people at high&#xD;
      diabetes risk (lean and overweight/obese women with PCOS, individuals with hyperinsulinemia,&#xD;
      individuals with impaired glucose tolerance) and diagnosed with diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The effect of meal frequency on diabetes risk markers (e.g. glucose and insulin metabolism)&#xD;
      has been studied in several studies so far, both in healthy individuals and in individuals&#xD;
      being at risk for diabetes mellitus, with or without concurrent weight loss. In addition, few&#xD;
      studies have investigated the effect of different meal frequency on glycemic control in&#xD;
      patients with diabetes mellitus under conditions of weight maintenance. However, the results&#xD;
      regarding the ideal number of meals remain controversial.&#xD;
&#xD;
      To our best knowledge, there is no study available that has investigated the effect of meal&#xD;
      frequency on glucose and insulin metabolism in lean and obese women with PCOS, in lean and&#xD;
      obese individuals with hyperinsulinemia and impaired glucose tolerance, and in obese&#xD;
      individuals with type 2 diabetes, independently of weight loss.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum levels of glucose</measure>
    <time_frame>6 months</time_frame>
    <description>Clinically useful change in serum glucose, defined as the restoration of glucose within normal limits during the 2-hour oral glucose tolerance test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum levels of insulin</measure>
    <time_frame>6 months</time_frame>
    <description>Clinically useful change in serum insulin, defined as the restoration of insulin within normal limits during the 2-hour oral glucose tolerance test. Improved insulin sensitivity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1c</measure>
    <time_frame>6 months</time_frame>
    <description>Clinically useful change in HbA1c.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipidemic profile</measure>
    <time_frame>6 months</time_frame>
    <description>Normal serum levels of cholesterol, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL) and Triglycerides.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Impaired Glucose Tolerance</condition>
  <condition>Hyperinsulinism</condition>
  <condition>Poor Glycemic Control</condition>
  <condition>Hyperglycemia</condition>
  <condition>Insulin Sensitivity</condition>
  <arm_group>
    <arm_group_label>Polycystic Ovary Syndrome</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>40 women with PCOS followed one of two isocaloric weight maintenance diets (isocaloric diet with 3 meals or isocaloric diet with 6 meals), tailored to individual energy needs, with the same macronutrient composition (40% carbohydrates, 25% protein, 35% fat). The energy and carbohydrate contribution for the 3 meals' diet was 20% at breakfast, 50% at lunch, 30% at dinner, whereas for the 6 meals' diet was 20% at breakfast, 10% at morning snack, 30% at lunch, 10% at afternoon snack, 20% at dinner, 10% at before bedtime snack. Each intervention lasted 12 weeks and there was no wash out period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Impaired Glucose Tolerance</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>35 individuals with Impaired Glucose Tolerance (IGT) followed one of two isocaloric weight maintenance diets (isocaloric diet with 3 meals or isocaloric diet with 6 meals), tailored to individual energy needs, with the same macronutrient composition (45% carbohydrates, 20% protein, 35% fat). The energy and carbohydrate contribution for the 3 meals' diet was 20% at breakfast, 50% at lunch, 30% at dinner, whereas for the 6 meals' diet was 20% at breakfast, 10% at morning snack, 30% at lunch, 10% at afternoon snack, 20% at dinner, 10% at before bedtime snack. Each intervention lasted 12 weeks and there was no wash out period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Type 2 Diabetes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 individuals diagnosed with type 2 diabetes followed one of two isocaloric weight maintenance diets (isocaloric diet with 3 meals or isocaloric diet with 6 meals), tailored to individual energy needs, with the same macronutrient composition (45% carbohydrates, 20% protein, 35% fat). The energy and carbohydrate contribution for the 3 meals' diet was 20% at breakfast, 50% at lunch, 30% at dinner, whereas for the 6 meals' diet was 20% at breakfast, 10% at morning snack, 30% at lunch, 10% at afternoon snack, 20% at dinner, 10% at before bedtime snack. Each intervention lasted 12 weeks and there was no wash out period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Isocaloric diet with 3 meals</intervention_name>
    <description>Isocaloric diet with 3 meals in order to maintain volunteers' weight, tailored to individual energy needs, with the same macronutrient composition. The volunteers were free to choose the foods they used to consume before. However, in order to assist them to adapt to the different meal frequency, individualized instructions were given to all volunteers before their entry to the study. An example of a 7-day diet menu was prescribed for both diet programs and analytical food exchange lists of different food groups were also provided.</description>
    <arm_group_label>Impaired Glucose Tolerance</arm_group_label>
    <arm_group_label>Polycystic Ovary Syndrome</arm_group_label>
    <arm_group_label>Type 2 Diabetes</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Isocaloric diet with 6 meals</intervention_name>
    <description>Isocaloric diet with 6 meals in order to maintain volunteers' weight, tailored to individual energy needs, with the same macronutrient composition. The volunteers were free to choose the foods they used to consume before. However, in order to assist them to adapt to the different meal frequency, individualized instructions were given to all volunteers before their entry to the study. An example of a 7-day diet menu was prescribed for both diet programs and analytical food exchange lists of different food groups were also provided.</description>
    <arm_group_label>Impaired Glucose Tolerance</arm_group_label>
    <arm_group_label>Polycystic Ovary Syndrome</arm_group_label>
    <arm_group_label>Type 2 Diabetes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The presence of type 2 diabetes was defined according to the current diagnostic&#xD;
             criteria: (a) HbA1c ≥ 6.5%, (b) fasting plasma glucose ≥126 mg/dl (7.0 mmol/l). (c)&#xD;
             2-h plasma glucose ≥ 200 mg/dl (11.1 mmol/l) during an oral glucose tolerance test&#xD;
             (OGTT), using a glucose load containing the equivalent of 75 g anhydrous glucose&#xD;
             dissolved in water, or (d) a random plasma glucose ≥ 200 mg/dl (11.1 mmol/l) in&#xD;
             patients with classic symptoms of hyperglycemia or hyperglycemic crisis.&#xD;
&#xD;
          -  PCOS was defined according to the Rotterdam criteria (Rotterdam 2004) which include&#xD;
             the presence of two or more of the following features: chronic oligoovulation or&#xD;
             anovulation (fewer than six menstrual periods in the previous year), androgen excess&#xD;
             (serum total testosterone &gt;70 mg/dl) and polycystic ovaries.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Insulin sensitizers, i.e. metformin, contraceptives, steroids or any medications known&#xD;
             to affect glucose, insulin or reproductive hormones for at least the last 6 months.&#xD;
&#xD;
          -  Serious health problems like cardiovascular, liver or kidney diseases.&#xD;
&#xD;
          -  Volunteers who were on diet, using medications affecting body mass or who had&#xD;
             experienced a change in body weight ≥ 4.5 kg or a change in physical activity within&#xD;
             the 6 months preceding the study onset were excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aimilia Papakonstantinou, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Agricultural University of Athens</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Meropi Kontogianni, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Harokopio University of Athens</affiliation>
  </overall_official>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>October 2, 2017</last_update_submitted>
  <last_update_submitted_qc>October 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Harokopio University</investigator_affiliation>
    <investigator_full_name>Meropi Kontogianni</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Polycystic ovary syndrome</keyword>
  <keyword>Type 2 Diabetes</keyword>
  <keyword>Hyperinsulinemia</keyword>
  <keyword>Meal frequency</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polycystic Ovary Syndrome</mesh_term>
    <mesh_term>Insulin Resistance</mesh_term>
    <mesh_term>Hyperglycemia</mesh_term>
    <mesh_term>Glucose Intolerance</mesh_term>
    <mesh_term>Hyperinsulinism</mesh_term>
    <mesh_term>Hypersensitivity</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/NCT02248272
org study id: 8062
secondary id: HUA
nct id: NCT02248272
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This study investigated any potential associations between two isocaloric diets with
      different meal frequency (3 meals versus 6 meals) and glycemic control in people at high
      diabetes risk (lean and overweight/obese women with PCOS, individuals with hyperinsulinemia,
      individuals with impaired glucose tolerance) and diagnosed with diabetes.
The effect of meal frequency on diabetes risk markers (e.g. glucose and insulin metabolism)
      has been studied in several studies so far, both in healthy individuals and in individuals
      being at risk for diabetes mellitus, with or without concurrent weight loss. In addition, few
      studies have investigated the effect of different meal frequency on glycemic control in
      patients with diabetes mellitus under conditions of weight maintenance. However, the results
      regarding the ideal number of meals remain controversial.

      To our best knowledge, there is no study available that has investigated the effect of meal
      frequency on glucose and insulin metabolism in lean and obese women with PCOS, in lean and
      obese individuals with hyperinsulinemia and impaired glucose tolerance, and in obese
      individuals with type 2 diabetes, independently of weight loss.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Serum levels of glucose
time frame: 6 months
description: Clinically useful change in serum glucose, defined as the restoration of glucose within normal limits during the 2-hour oral glucose tolerance test.
measure: Serum levels of insulin
time frame: 6 months
description: Clinically useful change in serum insulin, defined as the restoration of insulin within normal limits during the 2-hour oral glucose tolerance test. Improved insulin sensitivity.
measure: HbA1c
time frame: 6 months
description: Clinically useful change in HbA1c.
measure: Lipidemic profile
time frame: 6 months
description: Normal serum levels of cholesterol, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL) and Triglycerides.
arm group label: Polycystic Ovary Syndrome
arm group type: Experimental
description: 40 women with PCOS followed one of two isocaloric weight maintenance diets (isocaloric diet with 3 meals or isocaloric diet with 6 meals), tailored to individual energy needs, with the same macronutrient composition (40% carbohydrates, 25% protein, 35% fat). The energy and carbohydrate contribution for the 3 meals' diet was 20% at breakfast, 50% at lunch, 30% at dinner, whereas for the 6 meals' diet was 20% at breakfast, 10% at morning snack, 30% at lunch, 10% at afternoon snack, 20% at dinner, 10% at before bedtime snack. Each intervention lasted 12 weeks and there was no wash out period.
arm group label: Impaired Glucose Tolerance
arm group type: Experimental
description: 35 individuals with Impaired Glucose Tolerance (IGT) followed one of two isocaloric weight maintenance diets (isocaloric diet with 3 meals or isocaloric diet with 6 meals), tailored to individual energy needs, with the same macronutrient composition (45% carbohydrates, 20% protein, 35% fat). The energy and carbohydrate contribution for the 3 meals' diet was 20% at breakfast, 50% at lunch, 30% at dinner, whereas for the 6 meals' diet was 20% at breakfast, 10% at morning snack, 30% at lunch, 10% at afternoon snack, 20% at dinner, 10% at before bedtime snack. Each intervention lasted 12 weeks and there was no wash out period.
arm group label: Type 2 Diabetes
arm group type: Experimental
description: 12 individuals diagnosed with type 2 diabetes followed one of two isocaloric weight maintenance diets (isocaloric diet with 3 meals or isocaloric diet with 6 meals), tailored to individual energy needs, with the same macronutrient composition (45% carbohydrates, 20% protein, 35% fat). The energy and carbohydrate contribution for the 3 meals' diet was 20% at breakfast, 50% at lunch, 30% at dinner, whereas for the 6 meals' diet was 20% at breakfast, 10% at morning snack, 30% at lunch, 10% at afternoon snack, 20% at dinner, 10% at before bedtime snack. Each intervention lasted 12 weeks and there was no wash out period.
intervention type: Other
intervention name: Isocaloric diet with 3 meals
description: Isocaloric diet with 3 meals in order to maintain volunteers' weight, tailored to individual energy needs, with the same macronutrient composition. The volunteers were free to choose the foods they used to consume before. However, in order to assist them to adapt to the different meal frequency, individualized instructions were given to all volunteers before their entry to the study. An example of a 7-day diet menu was prescribed for both diet programs and analytical food exchange lists of different food groups were also provided.
arm group label: Impaired Glucose Tolerance
arm group label: Polycystic Ovary Syndrome
arm group label: Type 2 Diabetes
intervention type: Other
intervention name: Isocaloric diet with 6 meals
description: Isocaloric diet with 6 meals in order to maintain volunteers' weight, tailored to individual energy needs, with the same macronutrient composition. The volunteers were free to choose the foods they used to consume before. However, in order to assist them to adapt to the different meal frequency, individualized instructions were given to all volunteers before their entry to the study. An example of a 7-day diet menu was prescribed for both diet programs and analytical food exchange lists of different food groups were also provided.
arm group label: Impaired Glucose Tolerance
arm group label: Polycystic Ovary Syndrome
arm group label: Type 2 Diabetes
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Aimilia Papakonstantinou, PhD
role: Study Director
affiliation: Agricultural University of Athens
last name: Meropi Kontogianni, PhD
role: Principal Investigator
affiliation: Harokopio University of Athens
responsible party type: Sponsor-Investigator
investigator affiliation: Harokopio University
investigator full name: Meropi Kontogianni
investigator title: Assistant Professor
mesh term: Polycystic Ovary Syndrome
mesh term: Insulin Resistance
mesh term: Hyperglycemia
mesh term: Glucose Intolerance
mesh term: Hyperinsulinism
mesh term: Hypersensitivity