Effect Of Intermittent Fasting To Metabolic And Oxidative Stress Marker

Study Overview
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Brief Summary
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The world prevalence of obesity in adult population in 2016 was 650 million while in Indonesia, it has increased from 14,8 percent to 21,8 percent in 2018. Obesity is an established risk factors for metabolic and non communicable- diseases. The purpose of this research was to assess the different effect on waist circumference, insulin resistance and oxidative stress marker between fasting (intervention) group and not fasting (control) group after 8 weeks 5:2 intermittent fasting (IF) among obese male workers.

Detailed Description
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Intermittent fasting is eating pattern in that cycles between periods of fasting and eating. 5:2 intermittent fasting (IF) is a form of time-restricted fasting which no calories are consumed for at least 14 hours (for 4 am to 6 pm) will done in two non-consecutive days days per week, followed by ad libitum intake on the remaining days, with water restriction too. Participants will be distributed to each group by simple randomization. This study will access the characteristic data, dietary intake and physical activity from the participants. Anthropometry and blood sample (for insulin resistance (HOMA-IR) and oxidative stress (malondialdehyde and catalase)) were taken at baseline and at the end of the study. Participants from each group will gets counseling at the second week of intervention and they will follow up to 8 weeks with control and evaluation form.

Official Title
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Effect Of Intermittent Fasting 5: 2 To Waist Circumference, Insulin Resistance And Oxidative Stress Marker In Obese Workers In Jakarta

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Fasting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men aged 30-59 years Has a BMI ≥ 25 kg/m^2 Has a waist circumference of ≥ 90 cm Willingness to participate in the whole study by signing informed consent Exclusion Criteria: Doing regular fasting (2 days a week) for 12 weeks before the study begins. In a certain diet at the moment Participants who are taking drugs that can affect blood sugar, insulin, and drugs (steroids, beta blockers, adrenergics), vitamins or herbal supplements and other drugs that affect oxidative stress. Participants suffering from obesity with complications such as impaired liver function, impaired kidney function, heart disease and type 2 diabetes mellitus are known through anamnesis and physical examination as well as fasting blood sugar checks. Participants that has a fever with temperatures> 37.5 ℃

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Overall, this research will run for ± 10 weeks; 1 week of preparation, 8 weeks of intervention and 1 week of evaluation of the final results of the study. This research will involve an interview, physical examination and laboratory examination. This research is a clinical trial research with interventions in the form of fasting. There will be divided into two groups: the intervention group (fasting) and the control group (not fasting). The fasting group will fast every Monday and Thursday, while the fasting group consumes daily food as usual. Both groups will be given education about balanced nutrition.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>Participants will ask to do 5:2 intermittent fasting (2 non-consecutive days a week) within 8 weeks | Behavioral: Fasting<br>* Doing fasting 2 days a week within 8 weeks<br>|
| No Intervention: control<br>Participants will not doing fasting or intake restriction within 8 weeks | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin resistance | The pathological condition in which cells fail to respond normally to the hormone insulin. Assessed based on the HOMA-IR value | 8 weeks | 
| catalase level | Enzymatic antioxidant status of endogenous catalase in the blood, expressed in U/mg | 8 weeks | 
| plasma malondialdehyde level | the concentration of malondialdehyde (1,3-Propanedial) in the plasma as an oxidative stress marker measured by means of Will's method expressed in nmol/ml plasma unit | 8 weeks | 
| waist circumference | One way of anthropometry measurement to assess the visceral fat mass, so that it can evaluate the risk of metabolic disease. expressed in centimeter. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean caloric intake | the average amount of calories consumed daily by the participant which was determined from food diary and subsequent caloric contents calculation expressed in kilocalorie | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, intermittent fasting, insulin resistance, stress oxidative marker, waist circumference