Effect of Intermittent Fasting on Fat Mass

University of Indonesia (UI)

Status: Unknown

Conditions: Obesity

Treatments: Behavioral: Fasting

Study type: Interventional

Funder types: Other

Identifiers

NCT04245007

KET/1354/UN2.F1/ETIK

Details and patient eligibility

About

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.

Full 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).

Enrollment: 62 estimated patients

Sex: Male

Ages: 18 to 25 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

62 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Fasting

Control

No Intervention group

Description:

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