xml: <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/NCT06005519</url>
    </required_header>
    <id_info>
      <org_study_id>480</org_study_id>
      <nct_id>NCT06005519</nct_id>
    </id_info>
    <brief_title>The Short and Long-term Effects of Low Advanced Glycation End Product* Diet</brief_title>
    <acronym>AGE</acronym>
    <official_title>The Short and Long-term Effects of Low AGE Diet on Individuals With and Without Type 2 Diabetes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Marmara University Pendik Training and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Marmara University Pendik Training and Research Hospital</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>
        The aim of this study was to examine the hypothesis that a diet low in advanced glycation end&#xD;
        products (AGE) would provide short and long term improvement in metabolic and inflammatory&#xD;
        parameters and serum AGE, Srage, carboxymethyllysine (CML) and methylglyoxal (MG) values in&#xD;
        individuals with type 2 diabetes. Specifically, in order to observe the effect of AGE content&#xD;
        on the results, diabetic patients who are followed up and who know the principles of low&#xD;
        glycaemic index and glycaemic load nutrition suitable for diabetic patients, who do not have&#xD;
        additional diseases and who do not smoke were selected.&#xD;
  &#xD;
        In recent years, it has been determined that AGE accumulation in the tissue has an effect on&#xD;
        the pathophysiology of many diseases such as Alzheimer's disease as well as chronic&#xD;
        complications of diabetes. However, the contribution of dietary AGE intake to this pool is&#xD;
        controversial. There are studies with conflicting results in the literature on whether a low&#xD;
        AGE diet is effective on metabolic and biochemical well-being. In addition, studies&#xD;
        investigating the effects of reducing AGE content in the diet of people with no chronic&#xD;
        disease are limited.&#xD;
  &#xD;
        In this study, the metabolic results of dietary modification in the short term of 2 weeks and&#xD;
        in the long term of 3 months are determined. In addition, the results are analysed separately&#xD;
        in type 2 diabetic and non-diabetic groups. Thus, the data showing the short and long term&#xD;
        metabolic effects of dietary AGE levels for diabetic and non-diabetic patients will&#xD;
        contribute to the literature.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study included 30 volunteers with type 2 diabetes and 30 healthy participants. During the&#xD;
        initial interviews, participants were provided with training on low AGE (advanced glycation&#xD;
        end-products) dietary principles. In the same session, measurements were taken and recorded&#xD;
        for height, body weight, blood pressure, waist and hip circumference, and body fat&#xD;
        percentage. Fasting blood glucose, HbA1c, c-peptide, C reactive protein (CRP), insulin, blood&#xD;
        lipid levels, 1-5 anhydroglucitol (1-5 AG), AGE, Soluble AGE Receptor (sRAGE) , methylglyoxal&#xD;
        (MG) and carboxymethyllysine (CML) levels were measured through blood samples.&#xD;
  &#xD;
        Participants were asked to maintain a dietary journal and were followed up through weekly&#xD;
        online or face-to-face meetings. They were called in for a follow-up examination 2 weeks and&#xD;
        3 months after the initial interview. Anthropometric measurements and blood tests were&#xD;
        repeated.&#xD;
  &#xD;
        After the completion of a 3-month follow-up for all participants, measurements from both the&#xD;
        short and long term resulting from the low AGE diet were analyzed by comparing them to the&#xD;
        initial measurements, both for participants with and without diabetes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 1, 2018</start_date>
    <completion_date type="Actual">August 30, 2021</completion_date>
    <primary_completion_date type="Actual">August 30, 2021</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in serum AGE levels in short time period</measure>
      <time_frame>14 days</time_frame>
      <description>After a 2-week low AGE diet, a change in serum AGE levels in the diabetic and nondiabetic groups</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in serum AGE levels in long time period</measure>
      <time_frame>90 days</time_frame>
      <description>After a 3 months low AGE diet, a change in serum AGE levels in the diabetic and nondiabetic groups</description>
    </primary_outcome>
    <primary_outcome>
      <measure>change in body weight in short time period</measure>
      <time_frame>14 days</time_frame>
      <description>After a 2-week low AGE diet,change in body weight (kg) in diabetic and nondiabetic groups</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in body weight in long time period</measure>
      <time_frame>90 days</time_frame>
      <description>After a 3-months low AGE diet, change in body weight (kg) in diabetic and nondiabetic groups</description>
    </primary_outcome>
    <primary_outcome>
      <measure>change in body mass index in short time period</measure>
      <time_frame>14 days</time_frame>
      <description>After a 2-week low AGE diet,change in body mass index in diabetic and nondiabetic groups</description>
    </primary_outcome>
    <primary_outcome>
      <measure>change in body mass index in long time period</measure>
      <time_frame>90 days</time_frame>
      <description>After a 3-months low AGE diet, change in body mass index in diabetic and nondiabetic groups</description>
    </primary_outcome>
    <primary_outcome>
      <measure>change in waist circumference in short time period</measure>
      <time_frame>14 days</time_frame>
      <description>After a 2-week low AGE diet, change in waist circumference (cm) in diabetic and nondiabetic groups</description>
    </primary_outcome>
    <primary_outcome>
      <measure>change in waist circumference in long time period</measure>
      <time_frame>90 days</time_frame>
      <description>After a 3-months low AGE diet, change in waist circumference (cm) in diabetic and nondiabetic groups</description>
    </primary_outcome>
    <primary_outcome>
      <measure>change in hip circumference in short time period</measure>
      <time_frame>14 days</time_frame>
      <description>After a 2-week low AGE diet, change in hip circumference (cm) in diabetic and nondiabetic groups</description>
    </primary_outcome>
    <primary_outcome>
      <measure>change in hip circumference in long time period</measure>
      <time_frame>90 days</time_frame>
      <description>After a 3-months low AGE diet, change in hip circumference (cm) in diabetic and nondiabetic groups</description>
    </primary_outcome>
    <primary_outcome>
      <measure>change in body fat percentage in short time period</measure>
      <time_frame>14 days</time_frame>
      <description>After a 2-week low AGE diet,change in body fat percentage (%) in diabetic and nondiabetic groups</description>
    </primary_outcome>
    <primary_outcome>
      <measure>change in body fat percentage in long time period</measure>
      <time_frame>90 days</time_frame>
      <description>After a 3-months low AGE diet,change in body fat percentage (%) in diabetic and nondiabetic groups</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">60</enrollment>
    <condition>Diabetes Type 2</condition>
    <arm_group>
      <arm_group_label>Type 2 diabetes</arm_group_label>
      <arm_group_type>Other</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>healthy participants</arm_group_label>
      <arm_group_type>Other</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>low AGE diet education</intervention_name>
      <description>Participants were divided into ten-person groups. Each group was individually invited for a face-to-face meeting where they were provided with a 50-minute low-AGE diet education prepared in accordance with the recommendations of the American Diabetes Association and the Turkish Society of Endocrinology and Metabolism. During the first 20 minutes of the education, a PowerPoint presentation highlighted the importance of choosing plant-based, low-AGE foods and emphasized cooking methods such as boiling, steaming, and preparing meals with added liquids. Participants were advised against frying, roasting, and grilling. Additionally, information was provided on marinade techniques and the use of spices or ingredients such as lemon or vinegar to lower pH in meals. Following the education, participants were given a dietary diary to record their food intake and were asked to self-assess their diet adherence on a scale of 1 to 10 on a weekly basis.</description>
      <arm_group_label>Type 2 diabetes</arm_group_label>
      <arm_group_label>healthy participants</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  To have the competence to adhere to dietary recommendations&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Being &lt;18 years old or &gt;65 years old&#xD;
  &#xD;
            -  Having a history of serious cardiovascular diseases (atrial fibrillation, stroke,&#xD;
               ischemic heart disease, peripheral vascular disease, heart failure)&#xD;
  &#xD;
            -  Having chronic obstructive pulmonary disease&#xD;
  &#xD;
            -  Smoking&#xD;
  &#xD;
            -  Having kidney or liver failure&#xD;
  &#xD;
            -  Having a chronic gastrointestinal disease associated with malabsorption or chronic&#xD;
               pancreatitis&#xD;
  &#xD;
            -  Having a history of rheumatological disease&#xD;
  &#xD;
            -  Having a history of severe acute illness, malignancy, or alcohol abuse in the last 1&#xD;
               month&#xD;
  &#xD;
            -  Receiving immunosuppressive treatment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Istanbul University Istanbul Medical Faculty</name>
        <address>
          <city>Istanbul</city>
          <state>Fatih</state>
          <zip>34096</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Marmara University Pendik Training and Research Hospital</investigator_affiliation>
      <investigator_full_name>Buğu Usanma Koban</investigator_full_name>
      <investigator_title>Asst Prof</investigator_title>
    </responsible_party>
    <keyword>Advanced glycation end products</keyword>
    <keyword>diabetes</keyword>
    <keyword>nutrition</keyword>
    <keyword>diet</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06005519
  org study id: 480
  nct id: NCT06005519
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study was to examine the hypothesis that a diet low in advanced glycation end
        products (AGE) would provide short and long term improvement in metabolic and inflammatory
        parameters and serum AGE, Srage, carboxymethyllysine (CML) and methylglyoxal (MG) values in
        individuals with type 2 diabetes. Specifically, in order to observe the effect of AGE content
        on the results, diabetic patients who are followed up and who know the principles of low
        glycaemic index and glycaemic load nutrition suitable for diabetic patients, who do not have
        additional diseases and who do not smoke were selected.
  
        In recent years, it has been determined that AGE accumulation in the tissue has an effect on
        the pathophysiology of many diseases such as Alzheimer's disease as well as chronic
        complications of diabetes. However, the contribution of dietary AGE intake to this pool is
        controversial. There are studies with conflicting results in the literature on whether a low
        AGE diet is effective on metabolic and biochemical well-being. In addition, studies
        investigating the effects of reducing AGE content in the diet of people with no chronic
        disease are limited.
  
        In this study, the metabolic results of dietary modification in the short term of 2 weeks and
        in the long term of 3 months are determined. In addition, the results are analysed separately
        in type 2 diabetic and non-diabetic groups. Thus, the data showing the short and long term
        metabolic effects of dietary AGE levels for diabetic and non-diabetic patients will
        contribute to the literature.
  The study included 30 volunteers with type 2 diabetes and 30 healthy participants. During the
        initial interviews, participants were provided with training on low AGE (advanced glycation
        end-products) dietary principles. In the same session, measurements were taken and recorded
        for height, body weight, blood pressure, waist and hip circumference, and body fat
        percentage. Fasting blood glucose, HbA1c, c-peptide, C reactive protein (CRP), insulin, blood
        lipid levels, 1-5 anhydroglucitol (1-5 AG), AGE, Soluble AGE Receptor (sRAGE) , methylglyoxal
        (MG) and carboxymethyllysine (CML) levels were measured through blood samples.
  
        Participants were asked to maintain a dietary journal and were followed up through weekly
        online or face-to-face meetings. They were called in for a follow-up examination 2 weeks and
        3 months after the initial interview. Anthropometric measurements and blood tests were
        repeated.
  
        After the completion of a 3-month follow-up for all participants, measurements from both the
        short and long term resulting from the low AGE diet were analyzed by comparing them to the
        initial measurements, both for participants with and without diabetes.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Change in serum AGE levels in short time period
  time frame: 14 days
  description: After a 2-week low AGE diet, a change in serum AGE levels in the diabetic and nondiabetic groups
  measure: Change in serum AGE levels in long time period
  time frame: 90 days
  description: After a 3 months low AGE diet, a change in serum AGE levels in the diabetic and nondiabetic groups
  measure: change in body weight in short time period
  time frame: 14 days
  description: After a 2-week low AGE diet,change in body weight (kg) in diabetic and nondiabetic groups
  measure: Change in body weight in long time period
  time frame: 90 days
  description: After a 3-months low AGE diet, change in body weight (kg) in diabetic and nondiabetic groups
  measure: change in body mass index in short time period
  time frame: 14 days
  description: After a 2-week low AGE diet,change in body mass index in diabetic and nondiabetic groups
  measure: change in body mass index in long time period
  time frame: 90 days
  description: After a 3-months low AGE diet, change in body mass index in diabetic and nondiabetic groups
  measure: change in waist circumference in short time period
  time frame: 14 days
  description: After a 2-week low AGE diet, change in waist circumference (cm) in diabetic and nondiabetic groups
  measure: change in waist circumference in long time period
  time frame: 90 days
  description: After a 3-months low AGE diet, change in waist circumference (cm) in diabetic and nondiabetic groups
  measure: change in hip circumference in short time period
  time frame: 14 days
  description: After a 2-week low AGE diet, change in hip circumference (cm) in diabetic and nondiabetic groups
  measure: change in hip circumference in long time period
  time frame: 90 days
  description: After a 3-months low AGE diet, change in hip circumference (cm) in diabetic and nondiabetic groups
  measure: change in body fat percentage in short time period
  time frame: 14 days
  description: After a 2-week low AGE diet,change in body fat percentage (%) in diabetic and nondiabetic groups
  measure: change in body fat percentage in long time period
  time frame: 90 days
  description: After a 3-months low AGE diet,change in body fat percentage (%) in diabetic and nondiabetic groups
  arm group label: Type 2 diabetes
  arm group type: Other
  arm group label: healthy participants
  arm group type: Other
  intervention type: Other
  intervention name: low AGE diet education
  description: Participants were divided into ten-person groups. Each group was individually invited for a face-to-face meeting where they were provided with a 50-minute low-AGE diet education prepared in accordance with the recommendations of the American Diabetes Association and the Turkish Society of Endocrinology and Metabolism. During the first 20 minutes of the education, a PowerPoint presentation highlighted the importance of choosing plant-based, low-AGE foods and emphasized cooking methods such as boiling, steaming, and preparing meals with added liquids. Participants were advised against frying, roasting, and grilling. Additionally, information was provided on marinade techniques and the use of spices or ingredients such as lemon or vinegar to lower pH in meals. Following the education, participants were given a dietary diary to record their food intake and were asked to self-assess their diet adherence on a scale of 1 to 10 on a weekly basis.
  arm group label: Type 2 diabetes
  arm group label: healthy participants
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Marmara University Pendik Training and Research Hospital
  investigator full name: Buğu Usanma Koban
  investigator title: Asst Prof
  mesh term: Diabetes Mellitus, Type 2