Effect of Orange Juice Consumption Associated With Healthy Diet on Cardiometabolic Risk Factors of Individuals With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 主要终点
- LDL-C
研究概览
简要总结
This study aimed to verify if combination of a healthy diet and orange juice consumption can minimize cardiometabolic risk factors for Metabolic Syndrome (MetS)
详细描述
The clinical study was parallel, controlled, and randomized with metabolic syndrome subjects (ATPIII, AHA / NHLA) aimed at the consumption of an energy-balanced balanced diet for 12 weeks and divided into two groups: Control (n = 38): dietary guidance only; and Orange Juice (n = 38): diet guidance associated with 500 mL / day of 100% whole orange juice. The recruitment process began in June 2016, the intervention was carried out from September 2016 to December 2016, and the data analysis started in January 2016. The sample number took into account variances on LDL-C, with a type I error α = 0.05 and a type II error β = 0.2 (80% power). The minimum sample size should have 32 individuals per group (n = 64). Considering an approximately 15% dropout rate, the final sample size of study was constituted by 38 individuals per group. Primary and secondary endpoints were the reduction of LDL-C and modification of the levels of cardiometabolic risk factors, inflammatory and hemodynamics parameters, respectively. Kolmogorov Smirnov and Levene test assessed normality and homogeneity of data, respectively. T-test was conducted to identify possible differences between OJ and control groups at baseline. A linear mixed-effects model was apply to determine the time effect within and between groups (Sidak post hoc) and P significance was set up ≤ 0.05. The assessment of body composition, metabolic biomarkers and food intake were analyzed over a 12-week 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
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Three or more of the risk factors of MS: (1) waist circumference man ≥ 102 cm and woman ≥ 88 cm; (2) triglycerides ≥ 150 mg / dL; (3) HDL-C man ≤ 40 mg / dL and woman ≤ 50 mg / dL; (4) blood pressure ≥ 130 / ≥ 85 mm Hg and (5) fasting glucose ≥ 100 mg / dL (common diabetes, high blood pressure);
- •25 ≥ BMI ≤ 39.9 kg / m - overweight to grade II obesity;
- •Like to consume orange juice;
排除标准
- •Pregnant / nursing;
- •Use of vitamins or vitamin-food supplements in the last three months;
- •Individuals with diseases that require specific diet recommendations such as diabetes mellitus with insulin therapy and carbohydrate counts, cancer, chronic liver and kidney disease.
结局指标
主要结局
LDL-C
时间窗: 12 weeks
mg/dL
次要结局
- Common carotid artery intima-media thickness - CCA-IMT(12 weeks)
- Pulse wave velocity - PWV(12 weeks)
- Body fat mass(12 weeks)
- Insulin(12 weeks)
- hsCRP(12 weeks)
- IL-6(12 weeks)
- Cardiovascular risk index(12 weeks)
- HDL-C(12 weeks)
- Glucose(12 weeks)
- Waist circunference(12 weeks)
- Triglycerides(12 weeks)
- Blood pressure systolic and diastolic(12 weeks)
- Body lean mass(12 weeks)
- Visceral fat area(12 weeks)
- Total cholesterol(12 weeks)
- Body fat(12 weeks)
- ICAM(12 weeks)
- VCAM(12 weeks)
- TNF-alfa(12 weeks)
- Flow-mediated dilatation of the brachial artery - BA-FMD(12 weeks)
研究者
Thais Cesar
Principal Investigator
São Paulo State University