Effect Of Intermittent Fasting To Metabolic And Oxidative Stress Marker

April 8, 2020 updated by: Anni Rahmawati

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Indonesia
      • Jakarta, Indonesia, 13260
        • PT DELAMITA BiILANO
        • Contact:
          • Anni rahmawati
        • Contact:
          • Karima yudhistina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 59 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 ℃

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
insulin resistance
Time Frame: 8 weeks
The pathological condition in which cells fail to respond normally to the hormone insulin. Assessed based on the HOMA-IR value
8 weeks
catalase level
Time Frame: 8 weeks
Enzymatic antioxidant status of endogenous catalase in the blood, expressed in U/mg
8 weeks
plasma malondialdehyde level
Time Frame: 8 weeks
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
waist circumference
Time Frame: 8 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean caloric intake
Time Frame: 8 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anni Rahmawati

Investigators

  • Principal Investigator: Anni Rahmawati, postgraduate, Ilmu Gizi Fakultas Kedokteran Universitas Indonesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2020

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

March 20, 2020

First Submitted That Met QC Criteria

March 23, 2020

First Posted (Actual)

March 24, 2020

Study Record Updates

Last Update Posted (Actual)

April 10, 2020

Last Update Submitted That Met QC Criteria

April 8, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-02-0153

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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