Effects of Low Carbohydrate Diet Compared to Low Fat Diet in Reversing the Metabolic Syndrome Using NCEP ATP III Criteria; Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 主要终点
- Prevalence of metabolic syndrome
研究概览
简要总结
The National Cholesterol Education Program Adult Treatment Panel-III (NCEP ATP III) definition of metabolic syndrome (MetS)is one of the most widely used criteria of metabolic syndrome. It incorporates the key features of hyperglycemia/insulin resistance, visceral obesity, dyslipidemia and hypertension. According to the NCEP ATP III guidelines, in our study, the participants having the metabolic syndrome if they possess three or more of the following criteria: abdominal obesity: Increased waist circumference, Elevated serum triglycerides, Reduced high density lipoprotein cholesterol (HDL), Elevated blood pressure both systolic blood pressure (SBP) and diastolic and Elevated fasting blood glucose.
Although the pathogenesis of MetS is strongly linked to excessive food consumption, in particular fat intake, still there is no consensus about the effects of low carbohydrate diet (LCD) versus low fat diet (LFD) on reversing the MetS and on its metabolic risk factors. However, concerns have been raised with regard to the macronutrient shift with high carbohydrate restriction and the substantial intakes of fats, which may present unfavorable effects on cardiovascular disease risk factors. Meanwhile the LFD has generally been supported by studies to have beneficial effects on these risk factors.
There is no consensus about the effects of LCD versus LFD on the metabolic syndrome. This study investigated the effects of LCD versus LFD on the obese peoples and followed up them for 6 months. Out of 289 obese adults apparently healthy were randomly chosen by a stratified multistage probability sampling method, 94 of them are agreed to participate in the study. They were assigned randomly into low carbohydrate and low-fat diet groups. Both groups were followed up for 6 months and the data were taken at baseline, after 3 months and 6 months of intervention. Ninety-four obese participants completed the intervention.
详细描述
The metabolic syndrome (MetS) is a major and escalating public health and clinical challenge worldwide in the wake of urbanization, excess energy intake, increasing obesity, and sedentary life style. Metabolic syndrome a five-fold increasing the risk of type 2 diabetes mellitus (T2DM) and two fold increasing the risk of developing cardiovascular disease (CVD) over the next 5 to 10 years. Worldwide prevalence of MetS ranges from <10% to as much as 84%, depending on the region, urban or rural environment, population composition (sex, age, race, and ethnicity), and the definition of the syndrome used. The NCEP ATP III definition is one of the most widely used criteria of metabolic syndrome. It incorporates the key features of hyperglycaemia/insulin resistance, visceral obesity, dyslipidaemia and hypertension.
The treatment of metabolic syndrome intends to improve insulin sensitivity and correct the associated metabolic and cardiovascular abnormalities. During the past few years, several studies have evaluated the health effects of low carbohydrate-high protein diet (LCD), with emphasis on cardiovascular diseases versus low fat diet (LFD). Low-carbohydrate diet has become a popular strategy for weight loss and weight management in recent years. In addition, data from several randomized trials have demonstrated that LCD produced greater effects on weight loss and reducing cardiovascular and metabolic risk factors than LFD. A popular version of this LCD recommends extreme restriction of carbohydrate intake to less than 20 gram/day initially.
Although the pathogenesis of MetS is strongly linked to excessive food consumption, in particular fat intake, still there is no consensus about the effects of LCD versus LFD on reversing the MetS and on its metabolic risk factors. However, concerns have been raised with regard to the macronutrient shift with high CHO restriction and the substantial intakes of fats, which may present unfavorable effects on CVD risk factors. Meanwhile the LFD has generally been supported by studies to have beneficial effects on these risk factors.
The purpose of this study was to investigate the effects of a low carb diet compared to low fat diet on reversing and treating metabolic syndrome and their risk factors among a sample of obese adults in Erbil city/ Iraq Kurdistan.
This study is a randomized clinical trial conducted over 6 months, between (January and June 2017) with outcome assessments at baseline, at 3, and 6 months of intervention.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All adult obese participants
- •Had 3 or more of the following criteria of metabolic syndrome according to the NCEP
- •ATP III guidelines:
- •Abdominal obesity: increased waist circumference
- •Elevated triglycerides
- •Reduced HDL
- •Elevated blood pressure
- •Elevated fasting glucose
排除标准
- •Individuals with history or diagnosed with diseases and health related issues like:
- •Diabetes mellitus
- •Hypertension
- •Chronic skin disease
- •Heart disease
- •Hyperlipidemia
- •Malignant disease
- •Rheumatoid arthritis
- •Those who had undergone surgery during one month before the study
结局指标
主要结局
Prevalence of metabolic syndrome
时间窗: Baseline
The number of participants in the sample with the criteria of metabolic syndrome, divided by the total number of participants in the sample. According to the NCEP ATP III guidelines, the participants having the metabolic syndrome if they possess three or more of the following criteria: Abdominal obesity, elevated triglycerides, reduced HDL, elevated blood pressure and elevated fasting glucose.
Change from baseline in metabolic syndrome and at 6 months
时间窗: 6 months
Data on baseline characteristics of adult participants were expressed as means ± SD and/ or frequencies and percentage. The data checked for normal distribution by Shapiro-Wilk test; the p-value was 0.10 which indicates that the data was normally distributed. The study used t tests and Chi square test of association to compare baseline characteristics between both diet programs. An independent samples t-test was used to compare the means of a normally distributed metabolic risk factors for both independent diet programs at the baseline and after 6 months of intervention.
Compare prevalence of metabolic syndrome in both diet programs
时间窗: 6 months
A two-way repeated measures ANOVA was used to compare differences of metabolic dependent variables between the two independent variables, the LCD \& LFD, at baseline, after 3 months and after 6 months. To determine how much of an effect of intervention has had on the participants, the study used the following cut-offs to interpret the results: 0.14 or more are large effects, 0.06 are medium effects and 0.01 are small effects.
次要结局
- Body mass index(Baseline)
- Change from baseline in abdominal obesity and at 6 months(6 months)
- Change from baseline in elevated triglycerides and at 6 months(6 months)
- Change from baseline in reduced HDL and at 6 months(6 months)
- Change from baseline in elevated fasting glucose and at 6 months(6 months)
- Change from baseline in elevated blood pressure and at 6 months(6 months)
研究者
Sherzad Ali Ismael
Assistant Professor Dr. Sherzad Ali Ismael
Hawler Medical University