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Effect Of Intermittent Fasting To Metabolic And Oxidative Stress Marker

Primary Purpose

Obesity

Status

Unknown status

Phase

Not Applicable

Locations

Indonesia

Study Type

Interventional

Intervention

Fasting

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, intermittent fasting, insulin resistance, stress oxidative marker, waist circumference

Eligibility Criteria

30 Years - 59 Years (Adult)MaleAccepts 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 ℃

Sites / Locations

PT DELAMITA BiILANO

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention

control

Arm Description

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

Participants will not doing fasting or intake restriction within 8 weeks

Outcomes

Primary Outcome Measures

insulin resistance

The pathological condition in which cells fail to respond normally to the hormone insulin. Assessed based on the HOMA-IR value

catalase level

Enzymatic antioxidant status of endogenous catalase in the blood, expressed in U/mg

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

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT04319133

First Posted

March 20, 2020

Last Updated

April 8, 2020

Sponsor

Anni Rahmawati

1. Study Identification

Unique Protocol Identification Number

NCT04319133

Brief Title

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

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Unknown status

Study Start Date

June 2020 (Anticipated)

Primary Completion Date

August 2020 (Anticipated)

Study Completion Date

September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Anni Rahmawati

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

intervention

Arm Type

Experimental

Arm Description

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

Arm Title

control

Arm Type

No Intervention

Arm Description

Participants will not doing fasting or intake restriction within 8 weeks

Intervention Type

Behavioral

Intervention Name(s)

Fasting

Intervention Description

Doing fasting 2 days a week within 8 weeks

Primary Outcome Measure Information:

Title

insulin resistance

Description

The pathological condition in which cells fail to respond normally to the hormone insulin. Assessed based on the HOMA-IR value

Time Frame

8 weeks

Title

catalase level

Description

Enzymatic antioxidant status of endogenous catalase in the blood, expressed in U/mg

Time Frame

8 weeks

Title

plasma malondialdehyde level

Description

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

Time Frame

8 weeks

Title

waist circumference

Description

One way of anthropometry measurement to assess the visceral fat mass, so that it can evaluate the risk of metabolic disease. expressed in centimeter.

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

mean caloric intake

Description

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

Time Frame

8 weeks

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

menstruating women will lose blood, so if they still asked to fast, it can endanger themselves because the nutrition is getting less

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

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 ℃

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anni Rahmawati, postgraduate

Phone

6285260074015

annibustami@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Karima Yudhistina, postgraduate

Phone

6282126002211

karimayudhistina@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anni Rahmawati, postgraduate

Organizational Affiliation

Ilmu Gizi Fakultas Kedokteran Universitas Indonesia

Official's Role

Principal Investigator

Facility Information:

Facility Name

PT DELAMITA BiILANO

City

Jakarta

ZIP/Postal Code

13260

Country

Indonesia

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anni rahmawati

First Name & Middle Initial & Last Name & Degree

Karima yudhistina

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29754952

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.

Results Reference

result

PubMed Identifier

28791787

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.

Results Reference

result

PubMed Identifier

36224641

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.

Results Reference

derived

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Effect Of Intermittent Fasting To Metabolic And Oxidative Stress Marker

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