Effect of Intermittent Fasting on Fat Mass

January 26, 2020 updated by: Hadiyati Fudla, Indonesia University

Effect of 8 Weeks 5:2 Intermittent Fasting on Fat Mass Among Obese Male Students Aged 18-25 in Indonesia University

This study is aimed to assess the different effect on fat mass between fasting (intervention) group and not fasting (control) group after 8 weeks 5:2 intermittent fasting (IF) among obese male student aged 18-25. Female students are excluded because if they do any restriction intake during their menstruation period which is a lot of blood lost, it will be a risk for them.

This study is designed as non-blinding randomized control trial. Subject who adhere with less than 85 percent fasting (14 out of 16) will be dropped out from this study. Total sample in this study is 62 students which are 31 students for each group.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

5:2 intermittent fasting (IF) is eating pattern in which no or few calories are consumed for 13 hours (for 5 am to 6 pm) done in two non-consecutive days days per week, followed by ad libitum intake on the remaining days, without any requirement of water restriction.

Subjects will be distributed to each group by using randomization block of four.

This study will use 8 forms consist of; informed consent, subject selection form, re-anthropometric measurement form, questionnaire, semi quantitative food frequency questionnaire (SQ-FFQ), international physical activity questionnaire (IPAQ), food record book, and control and evaluation form. While the tolls are consist of food photograph book (to help in filling the food record book), body height scale, and bio-electrical impedance analysis (BIA) Seca medical body composition analyzer (mBCA) 515/514 (to measure body composition).

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 Locations

  • Indonesia
    • West Java
      • Depok, West Java, Indonesia, 16424
        • Indonesia University

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

18 years to 25 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • obese male student age 18-25
  • do not have experience on amputation
  • willingness to participate in the whole study by signing informed consent

Exclusion Criteria:

  • hypertrophy muscle students identified from body composition measurement
  • in a certain diet at the moment
  • consuming lipid-lowering drug at the moment
  • doing regular fasting (2 days a week) for 2 months before the study begin
  • suffer from chronic illness (confirmed by disease history form
  • using electronic implants, for example pacemaker or pane
  • using prostheses (artificial body part)

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention
Subject 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
Subject will prohibited from doing fasting or intake restriction within 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fat mass
Time Frame: 8 weeks
reduction fat mass in the intervention group measured by bio-electrical impedance analysis
8 weeks

Collaborators and Investigators

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

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Hadiyati HF Fudla, Indonesia University

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)

January 27, 2020

Primary Completion (ANTICIPATED)

April 9, 2020

Study Completion (ANTICIPATED)

April 9, 2020

Study Registration Dates

First Submitted

January 18, 2020

First Submitted That Met QC Criteria

January 26, 2020

First Posted (ACTUAL)

January 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 28, 2020

Last Update Submitted That Met QC Criteria

January 26, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KET/1354/UN2.F1/ETIK

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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