Effects of Time Restricted Feeding on Body Weight and Metabolic Syndrome Severity in the Obese Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Systolic BP (mmHg)
研究概览
简要总结
The obesity rate in Malaysia is higher than the average world obesity rate. Central obesity is a component of metabolic syndrome (MetS) which is also made up of dyslipidemia, impaired glucose tolerance, and hypertension. MetS is a continuum in the risk of developing cardiometabolic complication. Time Restricted Feeding (TRF) involves an extended physiological overnight fast. Researchers believe that the timing of meal intake that matches with the circadian rhythms is as important as the calories intake to prevent obesity and its complications. The investigators hypothesize that TRF is effective in weight control and improvement of metabolic severity. Subjects will be randomized into either the control group, which practices QQH dietary plan or intervention group, which practices TRF as an adjunct to QQH dietary plan.
Subjects will be followed up at week 12 and week 24 to assess adherence, efficacy and safety of TRF.
This study intends to fill a few research gaps as follows:
- Longer study duration of 6 months.
- This is the first study amongst the Asian population.
- Adherence level to TRF in real life setting is measured. This information can potentially predict the intensity level of TRF that are feasible for practice in real life and also its association with the efficacy of TRF.
- TRF is defined as eating within a≤12-hour period and fasting for at least 12 hours per day. This is the shortest fasting window studied so far.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •20-59 years of age
- •BMI 27.5kg/m2 - 39.9kg/m2
- •Smart phone users
- •Willing to lose weight
- •Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in the protocol.
排除标准
- •Those with history of cardiovascular disease, cerebrovascular accidents, degenerative or inflammatory diseases of the nervous system; epilepsy, malignancy, gastrointestinal disorders, thyroid disorders, diabetes or medications which could have had metabolic effects.
- •Women who are pregnant or breastfeeding.
- •Those who are currently practicing any form of intermittent fasting or newly enrolled into a dietary or slimming program within the past 3 months.
- •Subjects with any medical condition, which in the investigator's judgment may be associated with increased risk to the subject or may interfere with study assessments or outcomes.
- •Those currently on medication for chronic illness.
- •Permanent night shift worker
- •Those who need to practise Ramadan fasting during the period of this study.
结局指标
主要结局
Systolic BP (mmHg)
时间窗: baseline - 24 weeks
This is a parameter for the calculation of metabolic syndrome severity score.
Fasting blood sugar (mmol/L)
时间窗: baseline - 24 weeks
This is a parameter for the calculation of metabolic syndrome severity score.
Serum triglyceride(mmol/L)
时间窗: baseline - 24 weeks
This is a parameter for the calculation metabolic syndrome severity score.
Body weight (kg)
时间窗: baseline - 24 weeks
Mean body weight change will be calculated.
Waist circumference (cm)
时间窗: baseline - 24 weeks
This is a parameter for the calculation of metabolic syndrome severity score.
Serum high density lipoprotein (HDL) (mmol/L)
时间窗: baseline - 24 weeks
This is a parameter for the calculation metabolic syndrome severity score.
次要结局
- Number of days achieving TRF(baseline-24 weeks)
- Incidence of treatment-emergent adverse events [Safety ](baseline-24 weeks)
- Number of fasting hours per day(baseline - 24 weeks)
研究者
Dr Chean Kooi Yau
Principal investigator, senior lecturer
RCSI & UCD Malaysia Campus