Effect of Intermittent Fasting on Fat Mass

Study Overview
=================
Brief Summary
-----------------
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.

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).

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

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Fasting


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Subject will ask to do 5:2 intermittent fasting (2 non-consecutive days a week) within 8 weeks | Behavioral: Fasting<br>* Doing fasting 2 days a week within 8 weeks<br>|
| No Intervention: Control<br>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 | reduction fat mass in the intervention group measured by bio-electrical impedance analysis | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obese, intermittent fasting, fat mass, body fat reduction