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
1 other identifier
interventional
62
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Jan 2020
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2020
CompletedStudy Start
First participant enrolled
January 27, 2020
CompletedFirst Posted
Study publicly available on registry
January 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 9, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 9, 2020
CompletedJanuary 28, 2020
January 1, 2020
2 months
January 18, 2020
January 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fat mass
reduction fat mass in the intervention group measured by bio-electrical impedance analysis
8 weeks
Study Arms (2)
Intervention
EXPERIMENTALSubject will ask to do 5:2 intermittent fasting (2 non-consecutive days a week) within 8 weeks
Control
NO INTERVENTIONSubject will prohibited from doing fasting or intake restriction within 8 weeks
Interventions
Eligibility Criteria
You may qualify if:
- obese male student age 18-25
- do not have experience on amputation
- willingness to participate in the whole study by signing informed consent
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Indonesia University
Depok, West Java, 16424, Indonesia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hadiyati HF Fudla
Indonesia University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master Student at Faculty of Medicine
Study Record Dates
First Submitted
January 18, 2020
First Posted
January 28, 2020
Study Start
January 27, 2020
Primary Completion
April 9, 2020
Study Completion
April 9, 2020
Last Updated
January 28, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share