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Effect Of Intermittent Fasting To Metabolic And Oxidative Stress Marker

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04319133
Enrollment
62
Registered
2020-03-24
Start date
2020-06-30
Completion date
2020-09-30
Last updated
2020-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

obesity, intermittent fasting, insulin resistance, stress oxidative marker, waist circumference

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.

Interventions

BEHAVIORALFasting

Doing fasting 2 days a week within 8 weeks

Sponsors

Anni Rahmawati
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
MALE
Age
30 Years to 59 Years
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 ℃

Design outcomes

Primary

MeasureTime frameDescription
waist circumference8 weeksOne way of anthropometry measurement to assess the visceral fat mass, so that it can evaluate the risk of metabolic disease. expressed in centimeter.
insulin resistance8 weeksThe pathological condition in which cells fail to respond normally to the hormone insulin. Assessed based on the HOMA-IR value
catalase level8 weeksEnzymatic antioxidant status of endogenous catalase in the blood, expressed in U/mg
plasma malondialdehyde level8 weeksthe 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

Secondary

MeasureTime frameDescription
mean caloric intake8 weeksthe average amount of calories consumed daily by the participant which was determined from food diary and subsequent caloric contents calculation expressed in kilocalorie

Countries

Indonesia

Contacts

Primary ContactAnni Rahmawati, postgraduate
annibustami@gmail.com6285260074015
Backup ContactKarima Yudhistina, postgraduate
karimayudhistina@gmail.com6282126002211

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026