Does the Energy Restriction Intermittent Fasting Diet Alleviate Metabolic Syndrome Biomarkers?

Sponsor

Istanbul Medipol University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04502329

Collaborator

(none)

Enrollment

Location

Arms

16.3

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome	Other: Diet	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

65 participants

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.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

Official Title:

The Effect of Intermittent Fasting Diet on Metabolic Syndrome Biomarkers and Weight Management in Individuals With Metabolic Syndrome

Actual Study Start Date :

Jan 30, 2019

Actual Primary Completion Date :

Mar 10, 2020

Actual Study Completion Date :

Jun 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IER Intermittent Energy Restriction	Other: Diet Energy Restriction Intermittent Fasting Diet
No Intervention: CER Continous Energy Restriction

Arm

Intervention/Treatment

Experimental: IER

Intermittent Energy Restriction

Other: Diet

Energy Restriction Intermittent Fasting Diet

No Intervention: CER

Continous Energy Restriction

Outcome Measures

Primary Outcome Measures

Average weight and standard deviation of the participants [Change from Baseline Weight at 12 weeks]
Weight in kilograms, was measured with TANİTA SC-330 instrument.
Average height and standard deviation of the participants [Baseline]
Height measured with SECA-213 instrument.
Average Body Mass Indexand standard deviation of the participants [Change from Baseline Body Mass Index at 12 weeks]
Weight and Height were combined to report BMI in kg/m^2
Average Waist circumference and standard deviation of the participants [Change from Baseline Weight at 12 weeks]
Waist circumference in centimeters, was measured by the same dietician with the help of unstretched tape measure.
Concentration of Total Cholesterol [Change from Baseline Weight at 12 weeks]
Total cholesterol in mg/dL, results was provided from participant's clinician before and 12 weeks after diet.
Concentration of High-Density Cholesterol [Change from Baseline Weight at 12 weeks]
High Dansity Cholesterol in mg/dL, results was provided from participant's clinician before and 12 weeks after diet.
Concentration of Low-Density Cholesterol [Change from Baseline Weight at 12 weeks]
Low Dansity Cholesterol in mg/dL, results was provided from participant's clinician before and 12 weeks after diet.
Concentration of Triglyceride [Change from Baseline Weight at 12 weeks]
Triglyceride in mg/dL, results was provided from participant's clinician before and 12 weeks after diet.
Concentration of Fasting plasma glucose [Change from Baseline Weight at 12 weeks]
Fasting plasma glucose in mg/dL, was provided from participant's clinician before and 12 weeks after diet.
Concentration of Insülin [Change from Baseline Weight at 12 weeks]
Insülin in IU/L, was provided from participant's clinician before and 12 weeks after diet.
Rate of HOMA-IR [Change from Baseline Weight at 12 weeks]
HOMA-IR was calculated with fasting plasma glucose and insülin levels. HOMA-IR = (Fasting plasma glucose [mg/dL] x Insülin [IU/L] ) / 405
Concentration of HbA1c [Change from Baseline Weight at 12 weeks]
HbA1c what value was stated as a percentage (%), were provided from participant's clinician before and 12 weeks after diet.
Amount of Fat mass [Change from Baseline Weight at 12 weeks]
Fat mass in kilograms was measured with TANİTA SC-330 instrument.
Rate of Body fat percentage [Change from Baseline Weight at 12 weeks]
Body fat percentage was calculated combined with weight and fat mass. Body fat percentage = (Body mass [kg] / Weight [kg]) x 100.
Amount of Fat free mass [Change from Baseline Weight at 12 weeks]
Fat free mass in kilograms, was measured with TANİTA SC-330 instrument.
Amount of Total body water [Change from Baseline Weight at 12 weeks]
Total body water in kilograms, was measured with TANİTA SC-330 instrument.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Being between the ages of 18-65
Body mass index to be 27 and above
Clinical diagnosis of metabolic syndrome according to the criteria of IDF 2005 or NCP ATP III.

Exclusion Criteria:

Being in the pre-menopausal or menopause
Following a special diet (such as Celiac, Type 1 diabetes)
Using a special nutritional supplement (omega 3, probiotic, vitamin-mineral, teff seed etc.)
Those who do not comply with the diet, pregnant, being lactating
Doing heavy physical activity or working in a heavy job
Presence of liver, kidney or immune deficiency
Conditions that will seriously affect weight management such as having bariatric surgery
Determined to have had an unintentional sudden weight loss of more than 5% in the last three months
Not be practicing Muslim Ramadan fasting or had changed their dietary pattern 12 weeks before the study