Effect of 8 Weeks 5:2 Intermittent Fasting on Fat Mass Among Obese Male Students Aged 18-25 in Indonesia University
试验速览
- 阶段
- 不适用
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Fat mass
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •obese male student age 18-25
- •do not have experience on amputation
- •willingness to participate in the whole study by signing informed consent
排除标准
- •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)
结局指标
主要结局
Fat mass
时间窗: 8 weeks
reduction fat mass in the intervention group measured by bio-electrical impedance analysis
次要结局
未报告次要终点
研究者
Hadiyati Fudla
Master Student at Faculty of Medicine
Indonesia University