Effect Of Intermittent Fasting To Metabolic And Oxidative Stress Marker
2020年4月8日 更新者：Anni Rahmawati
Effect Of Intermittent Fasting 5: 2 To Waist Circumference, Insulin Resistance And Oxidative Stress Marker In Obese Workers In Jakarta
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (预期的)
62
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Anni Rahmawati, postgraduate
- 电话号码：6285260074015
- 邮箱：annibustami@gmail.com
研究联系人备份
- 姓名：Karima Yudhistina, postgraduate
- 电话号码：6282126002211
- 邮箱：karimayudhistina@gmail.com
学习地点
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Jakarta、印度尼西亚、13260
- PT DELAMITA BiILANO
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接触：
- Anni rahmawati
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接触：
- Karima yudhistina
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
30年 至 59年 (成人)
接受健康志愿者
是的
有资格学习的性别
男性
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 ℃
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：intervention
Participants will ask to do 5:2 intermittent fasting (2 non-consecutive days a week) within 8 weeks
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在 8 周内每周禁食 2 天
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无干预：control
Participants will not doing fasting or intake restriction within 8 weeks
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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insulin resistance
大体时间：8 weeks
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The pathological condition in which cells fail to respond normally to the hormone insulin.
Assessed based on the HOMA-IR value
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8 weeks
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catalase level
大体时间：8 weeks
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Enzymatic antioxidant status of endogenous catalase in the blood, expressed in U/mg
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8 weeks
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plasma malondialdehyde level
大体时间：8 weeks
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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
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8 weeks
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waist circumference
大体时间：8 weeks
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One way of anthropometry measurement to assess the visceral fat mass, so that it can evaluate the risk of metabolic disease.
expressed in centimeter.
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8 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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mean caloric intake
大体时间：8 weeks
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the average amount of calories consumed daily by the participant which was determined from food diary and subsequent caloric contents calculation expressed in kilocalorie
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8 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Anni Rahmawati, postgraduate、Ilmu Gizi Fakultas Kedokteran Universitas Indonesia
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Sutton EF, Beyl R, Early KS, Cefalu WT, Ravussin E, Peterson CM. Early Time-Restricted Feeding Improves Insulin Sensitivity, Blood Pressure, and Oxidative Stress Even without Weight Loss in Men with Prediabetes. Cell Metab. 2018 Jun 5;27(6):1212-1221.e3. doi: 10.1016/j.cmet.2018.04.010. Epub 2018 May 10.
- Conley M, Le Fevre L, Haywood C, Proietto J. Is two days of intermittent energy restriction per week a feasible weight loss approach in obese males? A randomised pilot study. Nutr Diet. 2018 Feb;75(1):65-72. doi: 10.1111/1747-0080.12372. Epub 2017 Aug 9.
- Witjaksono F, Prafiantini E, Rahmawati A. Effect of intermittent fasting 5:2 on body composition and nutritional intake among employees with obesity in Jakarta: a randomized clinical trial. BMC Res Notes. 2022 Oct 12;15(1):323. doi: 10.1186/s13104-022-06209-7.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2020年6月1日
初级完成 (预期的)
2020年8月1日
研究完成 (预期的)
2020年9月1日
研究注册日期
首次提交
2020年3月20日
首先提交符合 QC 标准的
2020年3月23日
首次发布 (实际的)
2020年3月24日
研究记录更新
最后更新发布 (实际的)
2020年4月10日
上次提交的符合 QC 标准的更新
2020年4月8日
最后验证
2020年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.