<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/NCT04502329</url>
  </required_header>
  <id_info>
    <org_study_id>10840098-604.01.01-E.1866</org_study_id>
    <nct_id>NCT04502329</nct_id>
  </id_info>
  <brief_title>Does the Energy Restriction Intermittent Fasting Diet Alleviate Metabolic Syndrome Biomarkers?</brief_title>
  <official_title>The Effect of Intermittent Fasting Diet on Metabolic Syndrome Biomarkers and Weight Management in Individuals With Metabolic Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul Medipol University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul Medipol University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this randomized controlled study determine the efficacy of calorie restriction&#xD;
      intermittent fasting diet in metabolic parameters and weight management among metabolic&#xD;
      syndromes adults. It was done on metabolic syndrome patients, aged 18-65 years at an academic&#xD;
      institution in Istanbul,Turkey. Subjects were divided into two groups; IER (Intermittent&#xD;
      Energy Restriction-intervention group, calori restriction of 300-500kcal/d combined with 16:8&#xD;
      model Intermittent Fasting) and CER (Countinous Energy Restriction- control group continous&#xD;
      restriction of 300-500kcal/d). Assessment was ascertained at baseline and 12 weeks. Blood&#xD;
      samples were analyzed for lipid profile, fasting plasma glucose, ınsulin, HOMA-IR. Blood&#xD;
      pressure and body composition were evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim The aim of this study; determine the efficacy of calorie restriction intermittent fasting&#xD;
      diet in metabolic parameters and weight management among metabolic syndromes adults.&#xD;
&#xD;
      Subjects Participants who referred by clinician, as medical doctors after physical assesment&#xD;
      selected in this study were recruited among patients with metabolic syndrome referring to the&#xD;
      diet clinic local in Turkey. The criteria of inclusion were metabolic syndrome patients, aged&#xD;
      18-65 years had body mass index (BMI) ≥27 kg/m2 with no history of mental or physical&#xD;
      disabilities.Subjects should also not be practicing Muslim Ramadan fasting or had changed&#xD;
      their dietary pattern 12 weeks before the study. Eligible subjects were approached to&#xD;
      participate. Only those who agreed to participate were explained of all the information&#xD;
      pertaining to this study and were consented. This study was approved by Istanbul Medipol&#xD;
      University Ethics Committee.&#xD;
&#xD;
      Study design The aim of A randomized controlled study was carried out to determine the&#xD;
      efficacy of calorie restriction intermittent fasting diet in metabolic parameters and weight&#xD;
      management among metabolic syndromes adults. Subjects were randomly assigned into two groups;&#xD;
      intervention IER (Intermittent Energy Restriction) and control CER (Continuous Energy&#xD;
      Restriction). Randomization, first participant assigned IER group an each eligible&#xD;
      participant was randomly assigned to either CER group or IER group. Those who were assigned&#xD;
      to two groups needed to adhere dietary regime, with a reduction of 300-500kcal/d from the&#xD;
      habitual energy intake for 12 weeks intervention period. Diet menus were prepared taking into&#xD;
      account the individual characteristics. IER participants abide by intermittent fasting which&#xD;
      time restricted 16:8 model diet. During 16 hours; such as at 04.00 pm- 08.00 am or 05.00 pm -&#xD;
      09.00 am or 07.00 pm - 11.00 am fasting hours, no food and calorie drink. But participants in&#xD;
      fasting hours can drink water, sugar free tea and mineral water, coffee without sauce. On the&#xD;
      other 8 hours, need to adhere energy restriction diet. Subjects were also provided with&#xD;
      seven-day food menu guidelines. Those who were assigned to two groups need to maintain their&#xD;
      present lifestyle. Analysis was carried out at two time points: baseline and week 12. In&#xD;
      order to ensure good compliance, subjects were contacted once a week via telephone calls.&#xD;
      Food diaries and were fasting log book presumed to the participants during each assessment&#xD;
      meeting. Subjects were given detailed instruction verbally and a reference guide on how to&#xD;
      fill up the food diaries and fasting log. Individual and group counseling were provided&#xD;
      before and during the intervention period.&#xD;
&#xD;
      Body composition, Blood Pressure, Biochemical markers Height was measured using SECA-213&#xD;
      portable stadiometer (SECA, Hamburg, Germany). Body composition was measured using TANITA&#xD;
      SC-330, body composition analyzer (TANITA Corp. Tokyo, Japan). All measurements were made in&#xD;
      the morning at participants fasted state. This instrument was calibrated each time before&#xD;
      measurement. Data from this instrument including body weight, BMI, body fat percentage, fat&#xD;
      mass, fat free mass and total body water.&#xD;
&#xD;
      Body mass index (BMI) was calculated as; BMI [kg/m2]= Weight[kg] / (Height[m] x Height[m])&#xD;
      Waist circumference was measured by the same dietician with the help of a standard&#xD;
      unstretched tape measure. Blood pressure and heart rate were measured using an automatic&#xD;
      oscillometric device (Omron M2 Basic, Japanese) after participants had rested in a seated&#xD;
      position for 5 min. A blood sample was drawn at baseline and after 12 weeks. Insulin&#xD;
      resistance was estimated with the homeostasis model assessment (HOMA-IR) and calculated as;&#xD;
      HOMA-IR= (Fasting plasma glucose [mg/dL] x Serum insulin [IU/L]) / 405&#xD;
&#xD;
      Biochemical markers blood lipids, fasting plasma glucose and Haemoglobin A1c (HbA1c) were&#xD;
      performed with standard methods. Serum concentrations of insulin were measured by&#xD;
      immunonephelometric methods. Adverse events were monitored by standardized questionnaires,&#xD;
      diary and at the last study visit by interview.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2019</start_date>
  <completion_date type="Actual">June 10, 2020</completion_date>
  <primary_completion_date type="Actual">March 10, 2020</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>Randomized control trial The first participant assigned Intermittent Energy Restriction Group, the others assigned Continous Energy Restricition group or Intertermittent Energy Restriction Group respectively.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Average weight and standard deviation of the participants</measure>
    <time_frame>Change from Baseline Weight at 12 weeks</time_frame>
    <description>Weight in kilograms, was measured with TANİTA SC-330 instrument.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average height and standard deviation of the participants</measure>
    <time_frame>Baseline</time_frame>
    <description>Height measured with SECA-213 instrument.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average Body Mass Indexand standard deviation of the participants</measure>
    <time_frame>Change from Baseline Body Mass Index at 12 weeks</time_frame>
    <description>Weight and Height were combined to report BMI in kg/m^2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average Waist circumference and standard deviation of the participants</measure>
    <time_frame>Change from Baseline Weight at 12 weeks</time_frame>
    <description>Waist circumference in centimeters, was measured by the same dietician with the help of unstretched tape measure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Concentration of Total Cholesterol</measure>
    <time_frame>Change from Baseline Weight at 12 weeks</time_frame>
    <description>Total cholesterol in mg/dL, results was provided from participant's clinician before and 12 weeks after diet.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Concentration of High-Density Cholesterol</measure>
    <time_frame>Change from Baseline Weight at 12 weeks</time_frame>
    <description>High Dansity Cholesterol in mg/dL, results was provided from participant's clinician before and 12 weeks after diet.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Concentration of Low-Density Cholesterol</measure>
    <time_frame>Change from Baseline Weight at 12 weeks</time_frame>
    <description>Low Dansity Cholesterol in mg/dL, results was provided from participant's clinician before and 12 weeks after diet.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Concentration of Triglyceride</measure>
    <time_frame>Change from Baseline Weight at 12 weeks</time_frame>
    <description>Triglyceride in mg/dL, results was provided from participant's clinician before and 12 weeks after diet.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Concentration of Fasting plasma glucose</measure>
    <time_frame>Change from Baseline Weight at 12 weeks</time_frame>
    <description>Fasting plasma glucose in mg/dL, was provided from participant's clinician before and 12 weeks after diet.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Concentration of Insülin</measure>
    <time_frame>Change from Baseline Weight at 12 weeks</time_frame>
    <description>Insülin in IU/L, was provided from participant's clinician before and 12 weeks after diet.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of HOMA-IR</measure>
    <time_frame>Change from Baseline Weight at 12 weeks</time_frame>
    <description>HOMA-IR was calculated with fasting plasma glucose and insülin levels. HOMA-IR = (Fasting plasma glucose [mg/dL] x Insülin [IU/L] ) / 405</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Concentration of HbA1c</measure>
    <time_frame>Change from Baseline Weight at 12 weeks</time_frame>
    <description>HbA1c what value was stated as a percentage (%), were provided from participant's clinician before and 12 weeks after diet.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Amount of Fat mass</measure>
    <time_frame>Change from Baseline Weight at 12 weeks</time_frame>
    <description>Fat mass in kilograms was measured with TANİTA SC-330 instrument.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of Body fat percentage</measure>
    <time_frame>Change from Baseline Weight at 12 weeks</time_frame>
    <description>Body fat percentage was calculated combined with weight and fat mass. Body fat percentage = (Body mass [kg] / Weight [kg]) x 100.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Amount of Fat free mass</measure>
    <time_frame>Change from Baseline Weight at 12 weeks</time_frame>
    <description>Fat free mass in kilograms, was measured with TANİTA SC-330 instrument.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Amount of Total body water</measure>
    <time_frame>Change from Baseline Weight at 12 weeks</time_frame>
    <description>Total body water in kilograms, was measured with TANİTA SC-330 instrument.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>IER</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intermittent Energy Restriction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CER</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Continous Energy Restriction</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diet</intervention_name>
    <description>Energy Restriction Intermittent Fasting Diet</description>
    <arm_group_label>IER</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being between the ages of 18-65&#xD;
&#xD;
          -  Body mass index to be 27 and above&#xD;
&#xD;
          -  Clinical diagnosis of metabolic syndrome according to the criteria of IDF 2005 or NCP&#xD;
             ATP III.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Being in the pre-menopausal or menopause&#xD;
&#xD;
          -  Following a special diet (such as Celiac, Type 1 diabetes)&#xD;
&#xD;
          -  Using a special nutritional supplement (omega 3, probiotic, vitamin-mineral, teff seed&#xD;
             etc.)&#xD;
&#xD;
          -  Those who do not comply with the diet, pregnant, being lactating&#xD;
&#xD;
          -  Doing heavy physical activity or working in a heavy job&#xD;
&#xD;
          -  Presence of liver, kidney or immune deficiency&#xD;
&#xD;
          -  Conditions that will seriously affect weight management such as having bariatric&#xD;
             surgery&#xD;
&#xD;
          -  Determined to have had an unintentional sudden weight loss of more than 5% in the last&#xD;
             three months&#xD;
&#xD;
          -  Not be practicing Muslim Ramadan fasting or had changed their dietary pattern 12 weeks&#xD;
             before the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Istanbul Medipol University</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Welton S, Minty R, O'Driscoll T, Willms H, Poirier D, Madden S, Kelly L. Intermittent fasting and weight loss: Systematic review. Can Fam Physician. 2020 Feb;66(2):117-125.</citation>
    <PMID>32060194</PMID>
  </results_reference>
  <results_reference>
    <citation>Rynders CA, Thomas EA, Zaman A, Pan Z, Catenacci VA, Melanson EL. Effectiveness of Intermittent Fasting and Time-Restricted Feeding Compared to Continuous Energy Restriction for Weight Loss. Nutrients. 2019 Oct 14;11(10):2442. doi: 10.3390/nu11102442.</citation>
    <PMID>31614992</PMID>
  </results_reference>
  <results_reference>
    <citation>Patterson RE, Sears DD. Metabolic Effects of Intermittent Fasting. Annu Rev Nutr. 2017 Aug 21;37:371-393. doi: 10.1146/annurev-nutr-071816-064634. Epub 2017 Jul 17.</citation>
    <PMID>28715993</PMID>
  </results_reference>
  <results_reference>
    <citation>Antoni R, Johnston KL, Collins AL, Robertson MD. Effects of intermittent fasting on glucose and lipid metabolism. Proc Nutr Soc. 2017 Aug;76(3):361-368. doi: 10.1017/S0029665116002986. Epub 2017 Jan 16.</citation>
    <PMID>28091348</PMID>
  </results_reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 4, 2020</last_update_submitted>
  <last_update_submitted_qc>August 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul Medipol University Hospital</investigator_affiliation>
    <investigator_full_name>yaseminkunduraci</investigator_full_name>
    <investigator_title>Clinical Dietitian</investigator_title>
  </responsible_party>
  <keyword>intermittent fasting</keyword>
  <keyword>metabolic syndrome</keyword>
  <keyword>time restricted diet</keyword>
  <keyword>energy restriction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>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/NCT04502329
org study id: 10840098-604.01.01-E.1866
nct id: NCT04502329
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this randomized controlled study determine the efficacy of calorie restriction
      intermittent fasting diet in metabolic parameters and weight management among metabolic
      syndromes adults. It was done on metabolic syndrome patients, aged 18-65 years at an academic
      institution in Istanbul,Turkey. Subjects were divided into two groups; IER (Intermittent
      Energy Restriction-intervention group, calori restriction of 300-500kcal/d combined with 16:8
      model Intermittent Fasting) and CER (Countinous Energy Restriction- control group continous
      restriction of 300-500kcal/d). Assessment was ascertained at baseline and 12 weeks. Blood
      samples were analyzed for lipid profile, fasting plasma glucose, ınsulin, HOMA-IR. Blood
      pressure and body composition were evaluated.
Aim The aim of this study; determine the efficacy of calorie restriction intermittent fasting
      diet in metabolic parameters and weight management among metabolic syndromes adults.

      Subjects Participants who referred by clinician, as medical doctors after physical assesment
      selected in this study were recruited among patients with metabolic syndrome referring to the
      diet clinic local in Turkey. The criteria of inclusion were metabolic syndrome patients, aged
      18-65 years had body mass index (BMI) ≥27 kg/m2 with no history of mental or physical
      disabilities.Subjects should also not be practicing Muslim Ramadan fasting or had changed
      their dietary pattern 12 weeks before the study. Eligible subjects were approached to
      participate. Only those who agreed to participate were explained of all the information
      pertaining to this study and were consented. This study was approved by Istanbul Medipol
      University Ethics Committee.

      Study design The aim of A randomized controlled study was carried out to determine the
      efficacy of calorie restriction intermittent fasting diet in metabolic parameters and weight
      management among metabolic syndromes adults. Subjects were randomly assigned into two groups;
      intervention IER (Intermittent Energy Restriction) and control CER (Continuous Energy
      Restriction). Randomization, first participant assigned IER group an each eligible
      participant was randomly assigned to either CER group or IER group. Those who were assigned
      to two groups needed to adhere dietary regime, with a reduction of 300-500kcal/d from the
      habitual energy intake for 12 weeks intervention period. Diet menus were prepared taking into
      account the individual characteristics. IER participants abide by intermittent fasting which
      time restricted 16:8 model diet. During 16 hours; such as at 04.00 pm- 08.00 am or 05.00 pm -
      09.00 am or 07.00 pm - 11.00 am fasting hours, no food and calorie drink. But participants in
      fasting hours can drink water, sugar free tea and mineral water, coffee without sauce. On the
      other 8 hours, need to adhere energy restriction diet. Subjects were also provided with
      seven-day food menu guidelines. Those who were assigned to two groups need to maintain their
      present lifestyle. Analysis was carried out at two time points: baseline and week 12. In
      order to ensure good compliance, subjects were contacted once a week via telephone calls.
      Food diaries and were fasting log book presumed to the participants during each assessment
      meeting. Subjects were given detailed instruction verbally and a reference guide on how to
      fill up the food diaries and fasting log. Individual and group counseling were provided
      before and during the intervention period.

      Body composition, Blood Pressure, Biochemical markers Height was measured using SECA-213
      portable stadiometer (SECA, Hamburg, Germany). Body composition was measured using TANITA
      SC-330, body composition analyzer (TANITA Corp. Tokyo, Japan). All measurements were made in
      the morning at participants fasted state. This instrument was calibrated each time before
      measurement. Data from this instrument including body weight, BMI, body fat percentage, fat
      mass, fat free mass and total body water.

      Body mass index (BMI) was calculated as; BMI [kg/m2]= Weight[kg] / (Height[m] x Height[m])
      Waist circumference was measured by the same dietician with the help of a standard
      unstretched tape measure. Blood pressure and heart rate were measured using an automatic
      oscillometric device (Omron M2 Basic, Japanese) after participants had rested in a seated
      position for 5 min. A blood sample was drawn at baseline and after 12 weeks. Insulin
      resistance was estimated with the homeostasis model assessment (HOMA-IR) and calculated as;
      HOMA-IR= (Fasting plasma glucose [mg/dL] x Serum insulin [IU/L]) / 405

      Biochemical markers blood lipids, fasting plasma glucose and Haemoglobin A1c (HbA1c) were
      performed with standard methods. Serum concentrations of insulin were measured by
      immunonephelometric methods. Adverse events were monitored by standardized questionnaires,
      diary and at the last study visit by interview.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized control trial The first participant assigned Intermittent Energy Restriction Group, the others assigned Continous Energy Restricition group or Intertermittent Energy Restriction Group respectively.
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Average weight and standard deviation of the participants
time frame: Change from Baseline Weight at 12 weeks
description: Weight in kilograms, was measured with TANİTA SC-330 instrument.
measure: Average height and standard deviation of the participants
time frame: Baseline
description: Height measured with SECA-213 instrument.
measure: Average Body Mass Indexand standard deviation of the participants
time frame: Change from Baseline Body Mass Index at 12 weeks
description: Weight and Height were combined to report BMI in kg/m^2
measure: Average Waist circumference and standard deviation of the participants
time frame: Change from Baseline Weight at 12 weeks
description: Waist circumference in centimeters, was measured by the same dietician with the help of unstretched tape measure.
measure: Concentration of Total Cholesterol
time frame: Change from Baseline Weight at 12 weeks
description: Total cholesterol in mg/dL, results was provided from participant's clinician before and 12 weeks after diet.
measure: Concentration of High-Density Cholesterol
time frame: Change from Baseline Weight at 12 weeks
description: High Dansity Cholesterol in mg/dL, results was provided from participant's clinician before and 12 weeks after diet.
measure: Concentration of Low-Density Cholesterol
time frame: Change from Baseline Weight at 12 weeks
description: Low Dansity Cholesterol in mg/dL, results was provided from participant's clinician before and 12 weeks after diet.
measure: Concentration of Triglyceride
time frame: Change from Baseline Weight at 12 weeks
description: Triglyceride in mg/dL, results was provided from participant's clinician before and 12 weeks after diet.
measure: Concentration of Fasting plasma glucose
time frame: Change from Baseline Weight at 12 weeks
description: Fasting plasma glucose in mg/dL, was provided from participant's clinician before and 12 weeks after diet.
measure: Concentration of Insülin
time frame: Change from Baseline Weight at 12 weeks
description: Insülin in IU/L, was provided from participant's clinician before and 12 weeks after diet.
measure: Rate of HOMA-IR
time frame: Change from Baseline Weight at 12 weeks
description: HOMA-IR was calculated with fasting plasma glucose and insülin levels. HOMA-IR = (Fasting plasma glucose [mg/dL] x Insülin [IU/L] ) / 405
measure: Concentration of HbA1c
time frame: Change from Baseline Weight at 12 weeks
description: HbA1c what value was stated as a percentage (%), were provided from participant's clinician before and 12 weeks after diet.
measure: Amount of Fat mass
time frame: Change from Baseline Weight at 12 weeks
description: Fat mass in kilograms was measured with TANİTA SC-330 instrument.
measure: Rate of Body fat percentage
time frame: Change from Baseline Weight at 12 weeks
description: Body fat percentage was calculated combined with weight and fat mass. Body fat percentage = (Body mass [kg] / Weight [kg]) x 100.
measure: Amount of Fat free mass
time frame: Change from Baseline Weight at 12 weeks
description: Fat free mass in kilograms, was measured with TANİTA SC-330 instrument.
measure: Amount of Total body water
time frame: Change from Baseline Weight at 12 weeks
description: Total body water in kilograms, was measured with TANİTA SC-330 instrument.
arm group label: IER
arm group type: Experimental
description: Intermittent Energy Restriction
arm group label: CER
arm group type: No Intervention
description: Continous Energy Restriction
intervention type: Other
intervention name: Diet
description: Energy Restriction Intermittent Fasting Diet
arm group label: IER
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Turkey
citation: Welton S, Minty R, O'Driscoll T, Willms H, Poirier D, Madden S, Kelly L. Intermittent fasting and weight loss: Systematic review. Can Fam Physician. 2020 Feb;66(2):117-125.
PMID: 32060194
citation: Rynders CA, Thomas EA, Zaman A, Pan Z, Catenacci VA, Melanson EL. Effectiveness of Intermittent Fasting and Time-Restricted Feeding Compared to Continuous Energy Restriction for Weight Loss. Nutrients. 2019 Oct 14;11(10):2442. doi: 10.3390/nu11102442.
PMID: 31614992
citation: Patterson RE, Sears DD. Metabolic Effects of Intermittent Fasting. Annu Rev Nutr. 2017 Aug 21;37:371-393. doi: 10.1146/annurev-nutr-071816-064634. Epub 2017 Jul 17.
PMID: 28715993
citation: Antoni R, Johnston KL, Collins AL, Robertson MD. Effects of intermittent fasting on glucose and lipid metabolism. Proc Nutr Soc. 2017 Aug;76(3):361-368. doi: 10.1017/S0029665116002986. Epub 2017 Jan 16.
PMID: 28091348
responsible party type: Principal Investigator
investigator affiliation: Istanbul Medipol University Hospital
investigator full name: yaseminkunduraci
investigator title: Clinical Dietitian
mesh term: Metabolic Syndrome
mesh term: Syndrome
sharing ipd: No