Effect Of Intermittent Fasting To Metabolic And Oxidative Stress Marker

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-30

Study Completion Date

2020-09-30

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.

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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intervention

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

Group Type EXPERIMENTAL

Fasting

Intervention Type BEHAVIORAL

Doing fasting 2 days a week within 8 weeks

control

Participants will not doing fasting or intake restriction within 8 weeks

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fasting

Doing fasting 2 days a week within 8 weeks

Intervention Type BEHAVIORAL

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 ℃

Minimum Eligible Age

30 Years

Maximum Eligible Age

59 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes