Clinical trial NCT04319133: Effect Of Intermittent Fasting To Metabolic And Oxidative Stress Marker
Official title: Effect Of Intermittent Fasting 5: 2 To Waist Circumference, Insulin Resistance And Oxidative Stress Marker In Obese Workers In Jakarta
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: obesity
intermittent fasting
insulin resistance
stress oxidative marker
waist circumference
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 62
Sex: MALE
Minimum age (years): 30
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 ℃

Primary outcomes:
measure: insulin resistance
timeFrame: 8 weeks
measure: catalase level
timeFrame: 8 weeks
measure: plasma malondialdehyde level
timeFrame: 8 weeks
measure: waist circumference
timeFrame: 8 weeks
Secondary outcomes:
measure: mean caloric intake
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: PT DELAMITA BiILANO
Study officials:
affiliation: Ilmu Gizi Fakultas Kedokteran Universitas Indonesia
name: Anni Rahmawati, postgraduate
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sutton EF, Beyl R, Early KS, Cefalu WT, Ravussin E, Peterson CM. Early Time-Restricted Feeding Improves Insulin Sensitivity, Blood Pressure, and Oxidative Stress Even without Weight Loss in Men with Prediabetes. Cell Metab. 2018 Jun 5;27(6):1212-1221.e3. doi: 10.1016/j.cmet.2018.04.010. Epub 2018 May 10.
citation: Conley M, Le Fevre L, Haywood C, Proietto J. Is two days of intermittent energy restriction per week a feasible weight loss approach in obese males? A randomised pilot study. Nutr Diet. 2018 Feb;75(1):65-72. doi: 10.1111/1747-0080.12372. Epub 2017 Aug 9.
citation: Witjaksono F, Prafiantini E, Rahmawati A. Effect of intermittent fasting 5:2 on body composition and nutritional intake among employees with obesity in Jakarta: a randomized clinical trial. BMC Res Notes. 2022 Oct 12;15(1):323. doi: 10.1186/s13104-022-06209-7.