Does the Energy Restriction Intermittent Fasting Diet Alleviate Metabolic Syndrome Biomarkers?
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Diet
Intervention type(s): Other
Intervention description(s): Energy Restriction Intermittent Fasting Diet
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.
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: intermittent fasting; metabolic syndrome; time restricted diet; energy restriction