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

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Diet
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Metabolic Syndrome focused on measuring intermittent fasting, metabolic syndrome, time restricted diet, energy restriction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Istanbul Medipol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

IER

CER

Arm Description

Intermittent Energy Restriction

Continous Energy Restriction

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 15, 2020
Last Updated
August 4, 2020
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04502329
Brief Title
Does the Energy Restriction Intermittent Fasting Diet Alleviate Metabolic Syndrome Biomarkers?
Official Title
The Effect of Intermittent Fasting Diet on Metabolic Syndrome Biomarkers and Weight Management in Individuals With Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 30, 2019 (Actual)
Primary Completion Date
March 10, 2020 (Actual)
Study Completion Date
June 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
intermittent fasting, metabolic syndrome, time restricted diet, energy restriction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IER
Arm Type
Experimental
Arm Description
Intermittent Energy Restriction
Arm Title
CER
Arm Type
No Intervention
Arm Description
Continous Energy Restriction
Intervention Type
Other
Intervention Name(s)
Diet
Intervention Description
Energy Restriction Intermittent Fasting Diet
Primary Outcome Measure Information:
Title
Average weight and standard deviation of the participants
Description
Weight in kilograms, was measured with TANİTA SC-330 instrument.
Time Frame
Change from Baseline Weight at 12 weeks
Title
Average height and standard deviation of the participants
Description
Height measured with SECA-213 instrument.
Time Frame
Baseline
Title
Average Body Mass Indexand standard deviation of the participants
Description
Weight and Height were combined to report BMI in kg/m^2
Time Frame
Change from Baseline Body Mass Index at 12 weeks
Title
Average Waist circumference and standard deviation of the participants
Description
Waist circumference in centimeters, was measured by the same dietician with the help of unstretched tape measure.
Time Frame
Change from Baseline Weight at 12 weeks
Title
Concentration of Total Cholesterol
Description
Total cholesterol in mg/dL, results was provided from participant's clinician before and 12 weeks after diet.
Time Frame
Change from Baseline Weight at 12 weeks
Title
Concentration of High-Density Cholesterol
Description
High Dansity Cholesterol in mg/dL, results was provided from participant's clinician before and 12 weeks after diet.
Time Frame
Change from Baseline Weight at 12 weeks
Title
Concentration of Low-Density Cholesterol
Description
Low Dansity Cholesterol in mg/dL, results was provided from participant's clinician before and 12 weeks after diet.
Time Frame
Change from Baseline Weight at 12 weeks
Title
Concentration of Triglyceride
Description
Triglyceride in mg/dL, results was provided from participant's clinician before and 12 weeks after diet.
Time Frame
Change from Baseline Weight at 12 weeks
Title
Concentration of Fasting plasma glucose
Description
Fasting plasma glucose in mg/dL, was provided from participant's clinician before and 12 weeks after diet.
Time Frame
Change from Baseline Weight at 12 weeks
Title
Concentration of Insülin
Description
Insülin in IU/L, was provided from participant's clinician before and 12 weeks after diet.
Time Frame
Change from Baseline Weight at 12 weeks
Title
Rate of HOMA-IR
Description
HOMA-IR was calculated with fasting plasma glucose and insülin levels. HOMA-IR = (Fasting plasma glucose [mg/dL] x Insülin [IU/L] ) / 405
Time Frame
Change from Baseline Weight at 12 weeks
Title
Concentration of HbA1c
Description
HbA1c what value was stated as a percentage (%), were provided from participant's clinician before and 12 weeks after diet.
Time Frame
Change from Baseline Weight at 12 weeks
Title
Amount of Fat mass
Description
Fat mass in kilograms was measured with TANİTA SC-330 instrument.
Time Frame
Change from Baseline Weight at 12 weeks
Title
Rate of Body fat percentage
Description
Body fat percentage was calculated combined with weight and fat mass. Body fat percentage = (Body mass [kg] / Weight [kg]) x 100.
Time Frame
Change from Baseline Weight at 12 weeks
Title
Amount of Fat free mass
Description
Fat free mass in kilograms, was measured with TANİTA SC-330 instrument.
Time Frame
Change from Baseline Weight at 12 weeks
Title
Amount of Total body water
Description
Total body water in kilograms, was measured with TANİTA SC-330 instrument.
Time Frame
Change from Baseline Weight at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Istanbul Medipol University
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32060194
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.
Results Reference
result
PubMed Identifier
31614992
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.
Results Reference
result
PubMed Identifier
28715993
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.
Results Reference
result
PubMed Identifier
28091348
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.
Results Reference
result

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

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