- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04245007
Effect of Intermittent Fasting on Fat Mass
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
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hadiyati HF Fudla
- Phone Number: +62 83879112832
- Email: hadiyati.fudla@alumni.ui.ac.id
Study Contact Backup
- Name: Ninik NM Mudjihartini
- Phone Number: +62 81514873276
Study Locations
-
-
West Java
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Depok, West Java, Indonesia, 16424
- Indonesia University
-
Contact:
- Hadiyati HF Fudla
- Phone Number: +62 83879112832
- Email: hadiyati.fudla@alumni.ui.ac.id
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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
Sponsor
Investigators
- Principal Investigator: Hadiyati HF Fudla, Indonesia University
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- KET/1354/UN2.F1/ETIK
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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