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Effect Of Intermittent Fasting To Metabolic And Oxidative Stress Marker

A

Anni Rahmawati

Status

Unknown

Conditions

Obesity

Treatments

Behavioral: Fasting

Study type

Interventional

Funder types

Other

Identifiers

NCT04319133
20-02-0153

Details and patient eligibility

About

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.

Full 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.

Enrollment

62 estimated patients

Sex

Male

Ages

30 to 59 years old

Volunteers

Accepts Healthy Volunteers

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 ℃

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

62 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Karima Yudhistina, postgraduate; Anni Rahmawati, postgraduate

Data sourced from clinicaltrials.gov

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