Effect Of Intermittent Fasting To Metabolic And Oxidative Stress Marker

Not Applicable

• Conditions: Obesity
• Interventions: Behavioral: Fasting

• Registration Number: NCT04319133
• Lead Sponsor: Anni Rahmawati

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.

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 Timeline

• Study First Submitted: 2020-03-20
• Study First Submitted QC: 2020-03-23
• Study First Posted: 2020-03-24
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-08
• Last Update Posted: 2020-04-10
• Study Start: 2020-06
• Primary Completion: 2020-08
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 62

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 ℃

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
catalase level	8 weeks	Enzymatic antioxidant status of endogenous catalase in the blood, expressed in U/mg
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
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

Name	Time	Method
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

Trial Locations

Locations (1)

PT DELAMITA BiILANO; 🇮🇩 Jakarta, Indonesia