Effect of Intermittent Fasting on Fat Mass

NCT ID: NCT04245007

Last Updated: 2020-01-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-27
• Study Completion Date: 2020-04-09

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).

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Subject will ask to do 5:2 intermittent fasting (2 non-consecutive days a week) within 8 weeks

Group Type: EXPERIMENTAL

Fasting

Intervention Type: BEHAVIORAL

Doing fasting 2 days a week within 8 weeks

Control

Subject will prohibited from doing fasting or intake restriction within 8 weeks

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Fasting

Doing fasting 2 days a week within 8 weeks

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Hadiyati Fudla

Master Student at Faculty of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hadiyati HF Fudla

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Locations

Indonesia University

Depok, West Java, Indonesia

Countries

Indonesia

Central Contacts

Hadiyati HF Fudla

Role: CONTACT

hadiyati.fudla@alumni.ui.ac.id

+62 83879112832

Ninik NM Mudjihartini

Role: CONTACT

+62 81514873276

Facility Contacts

Hadiyati HF Fudla

Role: primary

hadiyati.fudla@alumni.ui.ac.id

+62 83879112832

Other Identifiers

KET/1354/UN2.F1/ETIK

Identifier Type: -

Identifier Source: org_study_id