Effect of Intermittent Fasting on Fat Mass

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04245007
• Other study ID #: KET/1354/UN2.F1/ETIK
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 27, 2020
• Est. completion date: April 9, 2020

Study information

• Verified date: January 2020
• Source: Indonesia University
• Contact: Hadiyati HF Fudla
• Phone: +62 83879112832
• Email: hadiyati.fudla[@]alumni.ui.ac.id
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 62
• Est. completion date: April 9, 2020
• Est. primary completion date: April 9, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 25 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Fasting
Doing fasting 2 days a week within 8 weeks

Locations

Country	Name	City	State
Indonesia	Indonesia University	Depok	West Java

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fat mass	reduction fat mass in the intervention group measured by bio-electrical impedance analysis	8 weeks