Effect Of Intermittent Fasting To Metabolic And Oxidative Stress Marker

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04319133
• Other study ID #: 20-02-0153
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2020
• Est. completion date: September 2020

Study information

• Verified date: April 2020
• Source: Indonesia University
• Contact: Anni Rahmawati, postgraduate
• Phone: 6285260074015
• Email: annibustami[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 62
• Est. completion date: September 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 59 Years

Eligibility

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 ?

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity

Intervention

Behavioral:
• Fasting
Doing fasting 2 days a week within 8 weeks

Locations

Country	Name	City	State
Indonesia	PT DELAMITA BiILANO	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Anni Rahmawati

Country where clinical trial is conducted

Indonesia, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin resistance	The pathological condition in which cells fail to respond normally to the hormone insulin. Assessed based on the HOMA-IR value	8 weeks
Primary	catalase level	Enzymatic antioxidant status of endogenous catalase in the blood, expressed in U/mg	8 weeks
Primary	plasma malondialdehyde level	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	8 weeks
Primary	waist circumference	One way of anthropometry measurement to assess the visceral fat mass, so that it can evaluate the risk of metabolic disease. expressed in centimeter.	8 weeks
Secondary	mean caloric intake	the average amount of calories consumed daily by the participant which was determined from food diary and subsequent caloric contents calculation expressed in kilocalorie	8 weeks