Effect Of Intermittent Fasting To Metabolic And Oxidative Stress Marker

Sponsor

Anni Rahmawati (Other)

Overall Status

Unknown status

CT.gov ID

NCT04319133

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

20.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: Fasting	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2020

Anticipated Primary Completion Date :

Aug 1, 2020

Anticipated Study Completion Date :

Sep 1, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: intervention

Participants will ask to do 5:2 intermittent fasting (2 non-consecutive days a week) within 8 weeks

Behavioral: Fasting

Doing fasting 2 days a week within 8 weeks

No Intervention: control

Participants will not doing fasting or intake restriction within 8 weeks

Outcome Measures

Primary Outcome Measures

insulin resistance [8 weeks]
The pathological condition in which cells fail to respond normally to the hormone insulin. Assessed based on the HOMA-IR value
catalase level [8 weeks]
Enzymatic antioxidant status of endogenous catalase in the blood, expressed in U/mg
plasma malondialdehyde level [8 weeks]
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
waist circumference [8 weeks]
One way of anthropometry measurement to assess the visceral fat mass, so that it can evaluate the risk of metabolic disease. expressed in centimeter.

Secondary Outcome Measures

mean caloric intake [8 weeks]
the average amount of calories consumed daily by the participant which was determined from food diary and subsequent caloric contents calculation expressed in kilocalorie

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 59 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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 ℃