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临床试验/NCT05034653
NCT05034653已完成不适用

Cardiometabolic and Anthropometric Outcomes of Intermittent Fasting Among Overweight and Obese Civil Servants in Malaysia.

Ministry of Health, Malaysia6 个研究点 分布在 1 个国家目标入组 177 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
177
试验地点
6
主要终点
Body weight changes

研究概览

简要总结

This study was a quasi-experimental study established to determine the cardio-metabolic, anthropometric, dietary intake and quality of life changes following combined Intermittent Fasting Healthy Plate and Healthy Plate interventions among overweight and obese civil servants.

详细描述

BACKGROUND

Overweight and obesity among adults is a growing global public health threat and an essential risk factor for various non-communicable diseases. Although it is largely preventable, the worldwide prevalence of obesity nearly tripled from 1975 and 2016 and remained increasing each year. In 2016, more than 1.9 billion adults were overweight, and 650 million were obese. If this current trend continues, it is estimated that 2.7 billion and over 1 billion adults will be overweight and obese by 2025, respectively.

Since obesity occurs due to positive energy balance in the body, the strategies of preventing and treating obesity mainly focus on dietary modification and increasing physical activity. One form of calorie restriction dietary protocol is intermittent fasting (IF), which encompasses various eating diet plans that cycle between a period of fasting and non-fasting over a defined period to create a negative energy balance, hence inducing weight loss. Studies have shown that IF is effective in reducing body weight and improving metabolic outcome. Although the effects of wet IF have been well documented, the benefits of dry IF (except for Ramadan fasting) is not clearly indicated in previous studies. Dry IF is defined as complete fasting without food and fluid intake.

As portion size is a crucial determinant of energy intake, portion control by controlling the serving size is another practical method to reduce calorie intake and promote weight loss. This portion control method has been widely practised and studied worldwide, using different portion divisions depends on the culture and eating habits. Malaysia Healthy Plate, a portion control dietary plan, was created to translate the messages in Malaysia Dietary Guideline 2010 and the Malaysia Food Pyramid 2010. It is a visual tool that emphasises the quarter-quarter-half concept that provides a quick visual technique that helps ensure the intake of food is within the recommended guideline. Specifically, Malaysia Healthy Plate is a single-meal guide that divides the plate into a quarter plate of grains or grains products, a quarter plate of fish, poultry, meat or egg, and a half plate of fruits and vegetables.

While weight losses are reported in studies of conventional IF, the adaptive phenomenon of dry IF on Monday and Thursday on cardiometabolic and anthropometric outcomes is still unclear. Similarly, although the policy of Malaysia Healthy Plate has been widely practised and publicised since 2010, the effectiveness of this eating plan in improving cardiometabolic risks and promoting weight loss is still not well documented. Thus, this study aimed to determine the cardiometabolic, anthropometric, dietary intake and quality of life changes among overweight and obese civil servants following combined Intermittent Fasting and Healthy Plate (IFHP) and Healthy Plate (HP), and to explore the participants' experience throughout the study. The investigators want to investigate whether combining dry IF and HP diet protocol will improve those parameters compared to HP alone.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • aged 19-59 years
  • BMI of ≥ 23 kg/m2 (overweight or obese)
  • who is ready to participate in the intervention (was assessed through readiness to participate screening)
  • who can provide informed consent.

排除标准

  • has recent involvement in weight loss program/activity (intermittent fasting/diet changes/physical activity changes or any activities that are performed constantly to reduce weight)
  • suffering from any eating disorder
  • was diagnosed with diabetes and hypertension (on medication) or other metabolic health disturbances such as thyroid disease, chronic kidney disease, malignancy and polycystic ovarian syndrome (PCOS)
  • taking any medication or supplements that can affect study outcome
  • has lack of capacity/language skills to independently follow the protocol were excluded from this study.

结局指标

主要结局

Body weight changes

时间窗: Change from Baseline Body Weight at week 24

Body weight changes measured in kilogram

Fat Free Mass changes

时间窗: Change from Baseline Body Fat Mass at week 24

Fat Free Mass changes measured in kilograms

Fasting Blood Glucose changes

时间窗: Change from Baseline Fasting Blood Glucose at week 24

Fasting Blood Glucose changes measured in mmol/L

Fasting Total Cholesterol changes

时间窗: Change from Baseline Fasting Total Cholesterol at week 24

Fasting Total Cholesterol changes measured in mmol/L

Body mass index (BMI) changes

时间窗: Change from Baseline BMI at week 24

Body mass index changes measured in kg/m\^2 (weight in kilograms, height in meters)

Body Fat Mass changes

时间窗: Change from Baseline Body Fat Mass at week 24

Body Fat Mass changes measured in kilograms

2-hour Post Prandial Blood Glucose changes

时间窗: Change from Baseline 2-hour Post Prandial at week 24

2-hour Post Prandial changes measured in mmol/L

HbA1c changes

时间窗: Change from Baseline HbA1c at week 24

HbA1c changes measured in percentage

Waist-Hip Ratio (WHR) changes

时间窗: Change from Baseline WHR at week 24

WHR changes measured in centimeters (waist and hip circumference in centimeters)

Body Fat Percentage changes

时间窗: Change from Baseline Body Fat Percentage at week 24

Body Fat Percentage changes measured in percentage

Systolic Blood Pressure changes

时间窗: Change from Baseline Systolic Blood Pressure at week 24

Systolic Blood Pressure changes measured in mmHg

Fasting High-density Lipoprotein-Cholesterol (HDL-C) changes

时间窗: Change from Baseline Fasting HDL-C at week 24

Fasting HDL-C measured in mmol/L

Fasting Low-density Lipoprotein-Cholesterol (LDL-C) changes

时间窗: Change from Baseline Fasting LDL-C at week 24

Fasting LDL-C measured in mmol/L

Fasting Insulin changes

时间窗: Change from Baseline Fasting Insulin at week 24

Fasting Insulin measured in uU/ml

Diastolic Blood Pressure changes

时间窗: Change from Baseline Diastolic Blood Pressure at week 24

Diastolic Blood Pressure changes measured in mmHg

Fasting Triglyceride changes

时间窗: Change from Baseline Fasting Triglyceride at week 24

Fasting Triglyceride changes measured in mmol/L

次要结局

  • Dietary Intake changes(At baseline, week 12 and week 24)
  • Quality of Life changes(At baseline, week 12 and week 24)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Shazana Rifham binti Abdullah

Principle Investigator

Ministry of Health, Malaysia

研究点 (6)

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