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临床试验/NCT04319133
NCT04319133Unknown不适用

Effect Of Intermittent Fasting 5: 2 To Waist Circumference, Insulin Resistance And Oxidative Stress Marker In Obese Workers In Jakarta

Anni Rahmawati1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2020年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
62
试验地点
1
主要终点
catalase level

研究概览

简要总结

The world prevalence of obesity in adult population in 2016 was 650 million while in Indonesia, it has increased from 14,8 percent to 21,8 percent in 2018. Obesity is an established risk factors for metabolic and non communicable- diseases. The purpose of this research was to assess the different effect on waist circumference, insulin resistance and oxidative stress marker between fasting (intervention) group and not fasting (control) group after 8 weeks 5:2 intermittent fasting (IF) among obese male workers.

详细描述

Intermittent fasting is eating pattern in that cycles between periods of fasting and eating. 5:2 intermittent fasting (IF) is a form of time-restricted fasting which no calories are consumed for at least 14 hours (for 4 am to 6 pm) will done in two non-consecutive days days per week, followed by ad libitum intake on the remaining days, with water restriction too.

Participants will be distributed to each group by simple randomization. This study will access the characteristic data, dietary intake and physical activity from the participants. Anthropometry and blood sample (for insulin resistance (HOMA-IR) and oxidative stress (malondialdehyde and catalase)) were taken at baseline and at the end of the study. Participants from each group will gets counseling at the second week of intervention and they will follow up to 8 weeks with control and evaluation form.

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
30 Years 至 59 Years(Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •Men aged 30-59 years
  • •Has a BMI ≥ 25 kg/m^2
  • •Has a waist circumference of ≥ 90 cm
  • •Willingness to participate in the whole study by signing informed consent

排除标准

  • •Doing regular fasting (2 days a week) for 12 weeks before the study begins.
  • •In a certain diet at the moment
  • •Participants who are taking drugs that can affect blood sugar, insulin, and drugs (steroids, beta blockers, adrenergics), vitamins or herbal supplements and other drugs that affect oxidative stress.
  • •Participants suffering from obesity with complications such as impaired liver function, impaired kidney function, heart disease and type 2 diabetes mellitus are known through anamnesis and physical examination as well as fasting blood sugar checks.
  • •Participants that has a fever with temperatures> 37.5 ℃

研究组 & 干预措施

intervention

Experimental

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

干预措施: Fasting (Behavioral)

control

No Intervention

Participants will not doing fasting or intake restriction within 8 weeks

结局指标

主要结局

catalase level

时间窗: 8 weeks

Enzymatic antioxidant status of endogenous catalase in the blood, expressed in U/mg

insulin resistance

时间窗: 8 weeks

The pathological condition in which cells fail to respond normally to the hormone insulin. Assessed based on the HOMA-IR value

plasma malondialdehyde level

时间窗: 8 weeks

the concentration of malondialdehyde (1,3-Propanedial) in the plasma as an oxidative stress marker measured by means of Will's method expressed in nmol/ml plasma unit

waist circumference

时间窗: 8 weeks

One way of anthropometry measurement to assess the visceral fat mass, so that it can evaluate the risk of metabolic disease. expressed in centimeter.

次要结局

  • mean caloric intake(8 weeks)

研究者

发起方
Anni Rahmawati
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Anni Rahmawati

Student

Indonesia University

研究点 (1)

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