<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/NCT03227497</url>
  </required_header>
  <id_info>
    <org_study_id>EO120/2017</org_study_id>
    <nct_id>NCT03227497</nct_id>
  </id_info>
  <brief_title>Dietary Intake of Whole Walnuts in Adult Subjects Under Low Cardiovascular Risk</brief_title>
  <acronym>FitALA</acronym>
  <official_title>Investigation of Health Effects of Dietary Intake of Whole Walnuts in Adult Subjects Under Low Cardiovascular Risk Towards Established and Molecular Cardiovascular Risk Factors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Belgrade</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre of Research Excellence in Nutrition and Metabolism</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Belgrade</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>
      This cross-over study investigates health effects of dietary intake of whole walnuts towards&#xD;
      cardiovascular risk factors in adults under low cardiovascular risk.&#xD;
&#xD;
      Investigators hypothesize that daily intake of whole nuts as a replacement meal, would&#xD;
      improve cardiovascular risk factors, including traditional risk factors and molecular&#xD;
      biomarkers.&#xD;
&#xD;
      The participants are randomly assigned to receive either study treatment, or no treatment,&#xD;
      and are crossed after five weeks.&#xD;
&#xD;
      The study subjects are instructed to continue with their habitual diet and physical activity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recent literature data raise important questions on the beneficial effect of dietary fats.&#xD;
      Dietary intake of nuts, although with high caloric burden, is however characterized with high&#xD;
      intake of fatty acids with known beneficial health effects. Those fatty acids include mono-&#xD;
      (MUFA) and polyunsaturated fatty acids (PUFA), to whom beneficial health effects are&#xD;
      ascribed.&#xD;
&#xD;
      Among nuts, walnuts are characterized with comparatively high levels of MUFA and PUFA,&#xD;
      especially content of alpha-linolenic PUFA, considered essential fatty acid, since not&#xD;
      synthesized endogenously in humans. Dietary intake of alpha-linolenic acid is shown to be&#xD;
      inversely related with cardiovascular risk factors, both in interventional studies and&#xD;
      epidemiological cohorts. Molecular background of alpha-linolenic actions is bidirectional,&#xD;
      and includes the action itself, as well as beneficial endogenous conversion towards&#xD;
      long-chain fatty acids, including eicosapentaenoic and docosahexaenoic fatty acid.&#xD;
&#xD;
      Although high caloric intake is indicated with intake of walnuts, literature data suggest&#xD;
      that consumption of walnuts does not increase body weight.&#xD;
&#xD;
      Dietary intake of walnuts has been shown to decrease cholesterol fractions, triglycerides and&#xD;
      apolipoproteins in adult population. Also, consumption of walnuts was associated with&#xD;
      decrease in blood pressure.&#xD;
&#xD;
      The study design is cross-over, controlled, randomized nutritional intervention. The&#xD;
      participants are randomly assigned to receive either study treatment, or no treatment, and&#xD;
      are crossed after five weeks.&#xD;
&#xD;
      The study subjects are instructed to continue with their habitual diet and physical activity.&#xD;
      Additionally, study subjects are instructed to avoid walnuts and nuts other then study&#xD;
      treatment, during the complete study period of 10 weeks.&#xD;
&#xD;
      Sample size calculation was conducted by use of online calculators, and was based on the low&#xD;
      density lipoprotein (LDL) cholesterol. Namely, in order to achieve decrease in 0.5 mmol/L, in&#xD;
      a sample with projected standard deviation of 0.7 mmol/L, and type I and II errors being 0.2&#xD;
      and 0.05, respectively, 62 subjects are needed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 21, 2017</start_date>
  <completion_date type="Actual">July 15, 2017</completion_date>
  <primary_completion_date type="Actual">July 15, 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>
    <intervention_model_description>This study is a randomized, cross-over, controlled, 5-week nutritional intervention, investigating health effects of dietary intake of whole walnuts, as a replacement meal within habitual diet and lifestyle.&#xD;
At the beginning of the study, half of the study subjects are randomly assigned to a treatment arm with walnut consumption, or control arm without study intervention. Treatment arm considers consumption of pre-packed 56 g of whole walnuts daily, as a replacement meal. After 5 weeks, study subjects are crossed, for additional 5 weeks. At the beginning of the study, all subjects are instructed to continue with their habitual diet and physical activity during the study period of 10 weeks.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Independent researcher will perform statistical analyses, without prior knowledge on study treatment allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in LDL-cholesterol</measure>
    <time_frame>Baseline, 5 weeks, 10 weeks</time_frame>
    <description>Changes in LDL-cholesterol measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Systolic Blood Pressure</measure>
    <time_frame>Baseline, 5 weeks, 10 weeks</time_frame>
    <description>Changes in Systolic Blood Pressure, from baseline to endpoint, measured office-based at the following timepoints: 0 (baseline), 5 and 10 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Diastolic Blood Pressure</measure>
    <time_frame>Baseline, 5 weeks, 10 weeks</time_frame>
    <description>Changes in Diastolic Blood Pressure from baseline to endpoint, measured office-based at the following timepoints: 0 (baseline), 5 and 10 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in HDL-cholesterol</measure>
    <time_frame>Baseline, 5 weeks, 10 weeks</time_frame>
    <description>Changes in HDL-cholesterol measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in total cholesterol</measure>
    <time_frame>Baseline, 5 weeks, 10 weeks</time_frame>
    <description>Changes in total cholesterol measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in triglycerides</measure>
    <time_frame>Baseline, 5 weeks, 10 weeks</time_frame>
    <description>Changes in triglycerides measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in glucose metabolism biomarkers</measure>
    <time_frame>Baseline, 5 weeks, 10 weeks</time_frame>
    <description>Changes in glucose biomarkers measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in renal function parameters</measure>
    <time_frame>Baseline, 5 weeks, 10 weeks</time_frame>
    <description>Changes in renal function parameters measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in liver function parameters</measure>
    <time_frame>Baseline, 5 weeks, 10 weeks</time_frame>
    <description>Changes in liver function parameters measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in body weight</measure>
    <time_frame>Baseline, 5 weeks, 10 weeks</time_frame>
    <description>Changes in body weight measured by bio-impedance analyzer, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in waist circumference</measure>
    <time_frame>Baseline, 5 weeks, 10 weeks</time_frame>
    <description>Changes in waist circumference, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in percent of total body fat</measure>
    <time_frame>Baseline, 5 weeks, 10 weeks</time_frame>
    <description>Changes in percent of total body fat measured by bio-impedance analyzer, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of Physical Activity</measure>
    <time_frame>Baseline</time_frame>
    <description>Level of physical activity is assessed by use of standardized Physical Activity Questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological parameters</measure>
    <time_frame>5 weeks</time_frame>
    <description>Psychological parameters are assessed by use of standardized questionnaire for self-assessment of psychological implications of daily activities related to cardiovascular health .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in hematological parameters</measure>
    <time_frame>Baseline, 5 weeks, 10 weeks</time_frame>
    <description>Changes in hematological, from baseline to endpoint, measured by hematological clinical analyzer at the following timepoints: 0 (baseline), 5 and 10 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in number of leukocyte cells</measure>
    <time_frame>Baseline, 5 weeks, 10 weeks</time_frame>
    <description>Changes in number of leukocyte cells, from baseline to endpoint, measured by hematological clinical analyzer at the following timepoints: 0 (baseline), 5 and 10 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in total caloric intake</measure>
    <time_frame>Baseline, 5 weeks, 10 weeks</time_frame>
    <description>Changes in total caloric intake, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.&#xD;
Total caloric intake is measured by use of standardized dietary questionnaire namely 24-hour Dietary Recall.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in caloric intake of fats</measure>
    <time_frame>Baseline, 5 weeks, 10 weeks</time_frame>
    <description>Changes in caloric intake of fats, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.&#xD;
The caloric intake is measured by use of standardized dietary questionnaire, namely 24-hour Dietary Recall.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in caloric intake of carbohydrates</measure>
    <time_frame>Baseline, 5 weeks, 10 weeks</time_frame>
    <description>Changes in caloric intake of carbohydrates, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.&#xD;
The caloric intake is measured by use of standardized dietary questionnaire, namely 24-hour Dietary Recall.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in caloric intake of vitamin D</measure>
    <time_frame>Baseline, 5 weeks, 10 weeks</time_frame>
    <description>Changes in caloric intake of vitamin D, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.&#xD;
The caloric intake is measured by use of standardized dietary questionnaire, namely 24-hour Dietary Recall.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Cardiovascular Risk Factor</condition>
  <condition>Metabolic Syndrome</condition>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Walnut</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>At the beginning of the study, subjects are randomly assigned to receive either intervention treatment (whole walnuts) or no treatment (control arm).&#xD;
Treatment arm includes 56 g of whole walnuts daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>At the beginning of the study, subjects are randomly assigned to receive either intervention treatment (whole walnuts) or no treatment (control arm).</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Whole Walnuts</intervention_name>
    <description>Intervention arm includes whole walnuts taken as dietary replacement meal during the day, and between breakfast and lunch, and/or lunch and dinner. Importantly, none of the main meals, including breakfast, lunch and dinner are to be replaced by study intervention, and the study subjects are instructed to do so. Walnuts are provided with the same producer at the Belgrade market.</description>
    <arm_group_label>Walnut</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Presence of at least one of the following criteria, formerly assessed through routine&#xD;
        medical examination:&#xD;
&#xD;
          -  dyslipidemia, defined as the presence of either: elevated total cholesterol (&gt;5.2&#xD;
             mmoL/L), and/or elevated LDL-cholesterol (&gt;3.4 mmoL/L), and/or elevated triglycerides&#xD;
             (&gt;1.7 mmoL/L), and/or decreased HDL-cholesterol (&lt;1.6 mmoL/L)&#xD;
&#xD;
          -  elevated blood pressure (systolic/diastolic ≥120/80 mmHg), or regular&#xD;
             anti-hypertension therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  presence of allergy on any nuts&#xD;
&#xD;
          -  presence of any chronic disease, excluding following conditions: hypertension and&#xD;
             diabetes mellitus type 2&#xD;
&#xD;
          -  smoking&#xD;
&#xD;
          -  statin therapy&#xD;
&#xD;
          -  pregnancy and/or lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria Glibetic, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Resaerch</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Serbia</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 17, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>July 21, 2017</last_update_submitted>
  <last_update_submitted_qc>July 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Belgrade</investigator_affiliation>
    <investigator_full_name>Manja Zec</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>Blood Pressure</keyword>
  <keyword>Cholesterol</keyword>
  <keyword>Triglycerides</keyword>
  <keyword>Walnuts</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</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/NCT03227497
org study id: EO120/2017
nct id: NCT03227497
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This cross-over study investigates health effects of dietary intake of whole walnuts towards
      cardiovascular risk factors in adults under low cardiovascular risk.

      Investigators hypothesize that daily intake of whole nuts as a replacement meal, would
      improve cardiovascular risk factors, including traditional risk factors and molecular
      biomarkers.

      The participants are randomly assigned to receive either study treatment, or no treatment,
      and are crossed after five weeks.

      The study subjects are instructed to continue with their habitual diet and physical activity.
Recent literature data raise important questions on the beneficial effect of dietary fats.
      Dietary intake of nuts, although with high caloric burden, is however characterized with high
      intake of fatty acids with known beneficial health effects. Those fatty acids include mono-
      (MUFA) and polyunsaturated fatty acids (PUFA), to whom beneficial health effects are
      ascribed.

      Among nuts, walnuts are characterized with comparatively high levels of MUFA and PUFA,
      especially content of alpha-linolenic PUFA, considered essential fatty acid, since not
      synthesized endogenously in humans. Dietary intake of alpha-linolenic acid is shown to be
      inversely related with cardiovascular risk factors, both in interventional studies and
      epidemiological cohorts. Molecular background of alpha-linolenic actions is bidirectional,
      and includes the action itself, as well as beneficial endogenous conversion towards
      long-chain fatty acids, including eicosapentaenoic and docosahexaenoic fatty acid.

      Although high caloric intake is indicated with intake of walnuts, literature data suggest
      that consumption of walnuts does not increase body weight.

      Dietary intake of walnuts has been shown to decrease cholesterol fractions, triglycerides and
      apolipoproteins in adult population. Also, consumption of walnuts was associated with
      decrease in blood pressure.

      The study design is cross-over, controlled, randomized nutritional intervention. The
      participants are randomly assigned to receive either study treatment, or no treatment, and
      are crossed after five weeks.

      The study subjects are instructed to continue with their habitual diet and physical activity.
      Additionally, study subjects are instructed to avoid walnuts and nuts other then study
      treatment, during the complete study period of 10 weeks.

      Sample size calculation was conducted by use of online calculators, and was based on the low
      density lipoprotein (LDL) cholesterol. Namely, in order to achieve decrease in 0.5 mmol/L, in
      a sample with projected standard deviation of 0.7 mmol/L, and type I and II errors being 0.2
      and 0.05, respectively, 62 subjects are needed.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: This study is a randomized, cross-over, controlled, 5-week nutritional intervention, investigating health effects of dietary intake of whole walnuts, as a replacement meal within habitual diet and lifestyle.
At the beginning of the study, half of the study subjects are randomly assigned to a treatment arm with walnut consumption, or control arm without study intervention. Treatment arm considers consumption of pre-packed 56 g of whole walnuts daily, as a replacement meal. After 5 weeks, study subjects are crossed, for additional 5 weeks. At the beginning of the study, all subjects are instructed to continue with their habitual diet and physical activity during the study period of 10 weeks.
primary purpose: Prevention
masking: None (Open Label)
masking description: Independent researcher will perform statistical analyses, without prior knowledge on study treatment allocation.
measure: Changes in LDL-cholesterol
time frame: Baseline, 5 weeks, 10 weeks
description: Changes in LDL-cholesterol measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
measure: Changes in Systolic Blood Pressure
time frame: Baseline, 5 weeks, 10 weeks
description: Changes in Systolic Blood Pressure, from baseline to endpoint, measured office-based at the following timepoints: 0 (baseline), 5 and 10 weeks.
measure: Changes in Diastolic Blood Pressure
time frame: Baseline, 5 weeks, 10 weeks
description: Changes in Diastolic Blood Pressure from baseline to endpoint, measured office-based at the following timepoints: 0 (baseline), 5 and 10 weeks.
measure: Changes in HDL-cholesterol
time frame: Baseline, 5 weeks, 10 weeks
description: Changes in HDL-cholesterol measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
measure: Changes in total cholesterol
time frame: Baseline, 5 weeks, 10 weeks
description: Changes in total cholesterol measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
measure: Changes in triglycerides
time frame: Baseline, 5 weeks, 10 weeks
description: Changes in triglycerides measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
measure: Changes in glucose metabolism biomarkers
time frame: Baseline, 5 weeks, 10 weeks
description: Changes in glucose biomarkers measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
measure: Changes in renal function parameters
time frame: Baseline, 5 weeks, 10 weeks
description: Changes in renal function parameters measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
measure: Changes in liver function parameters
time frame: Baseline, 5 weeks, 10 weeks
description: Changes in liver function parameters measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
measure: Changes in body weight
time frame: Baseline, 5 weeks, 10 weeks
description: Changes in body weight measured by bio-impedance analyzer, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
measure: Changes in waist circumference
time frame: Baseline, 5 weeks, 10 weeks
description: Changes in waist circumference, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
measure: Changes in percent of total body fat
time frame: Baseline, 5 weeks, 10 weeks
description: Changes in percent of total body fat measured by bio-impedance analyzer, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
measure: Level of Physical Activity
time frame: Baseline
description: Level of physical activity is assessed by use of standardized Physical Activity Questionnaire.
measure: Psychological parameters
time frame: 5 weeks
description: Psychological parameters are assessed by use of standardized questionnaire for self-assessment of psychological implications of daily activities related to cardiovascular health .
measure: Changes in hematological parameters
time frame: Baseline, 5 weeks, 10 weeks
description: Changes in hematological, from baseline to endpoint, measured by hematological clinical analyzer at the following timepoints: 0 (baseline), 5 and 10 weeks.
measure: Changes in number of leukocyte cells
time frame: Baseline, 5 weeks, 10 weeks
description: Changes in number of leukocyte cells, from baseline to endpoint, measured by hematological clinical analyzer at the following timepoints: 0 (baseline), 5 and 10 weeks.
measure: Changes in total caloric intake
time frame: Baseline, 5 weeks, 10 weeks
description: Changes in total caloric intake, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
Total caloric intake is measured by use of standardized dietary questionnaire namely 24-hour Dietary Recall.
measure: Changes in caloric intake of fats
time frame: Baseline, 5 weeks, 10 weeks
description: Changes in caloric intake of fats, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
The caloric intake is measured by use of standardized dietary questionnaire, namely 24-hour Dietary Recall.
measure: Changes in caloric intake of carbohydrates
time frame: Baseline, 5 weeks, 10 weeks
description: Changes in caloric intake of carbohydrates, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
The caloric intake is measured by use of standardized dietary questionnaire, namely 24-hour Dietary Recall.
measure: Changes in caloric intake of vitamin D
time frame: Baseline, 5 weeks, 10 weeks
description: Changes in caloric intake of vitamin D, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
The caloric intake is measured by use of standardized dietary questionnaire, namely 24-hour Dietary Recall.
arm group label: Walnut
arm group type: Active Comparator
description: At the beginning of the study, subjects are randomly assigned to receive either intervention treatment (whole walnuts) or no treatment (control arm).
Treatment arm includes 56 g of whole walnuts daily.
arm group label: Control
arm group type: No Intervention
description: At the beginning of the study, subjects are randomly assigned to receive either intervention treatment (whole walnuts) or no treatment (control arm).
intervention type: Dietary Supplement
intervention name: Whole Walnuts
description: Intervention arm includes whole walnuts taken as dietary replacement meal during the day, and between breakfast and lunch, and/or lunch and dinner. Importantly, none of the main meals, including breakfast, lunch and dinner are to be replaced by study intervention, and the study subjects are instructed to do so. Walnuts are provided with the same producer at the Belgrade market.
arm group label: Walnut
criteria: 
gender: All
minimum age: 30 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Maria Glibetic, Prof
role: Principal Investigator
affiliation: Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Resaerch
facility: 
country: Serbia
responsible party type: Principal Investigator
investigator affiliation: University of Belgrade
investigator full name: Manja Zec
investigator title: Dr
mesh term: Metabolic Syndrome
sharing ipd: No