Effects of Daily Walnut Intake Among the Subjects With Metabolic Syndrome in South Korea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- changes of blood glucose level
研究概览
简要总结
Investigators planed to conduct a randomized, controlled, crossover trial to examine the effects of daily walnuts intake among Korean subjects with metabolic syndrome. Primary objective of this study was to investigate the effects of daily walnut intake on changes of metabolic syndrome indices in Koreans with metabolic syndrome age over 30 years old. This study was consisted of four periods: run-in, first intervention, wash-out, and second intervention phases. As 16 weeks of first intervention period began after the run-in phase, the subjects were randomly assigned into one of two groups: walnut group and control group. Participants in walnut group consumed 45 grams of walnuts on a daily basis and participants in control group were provided iso-caloric white bread for first 16 weeks. After the first intervention and wash-out period (6 weeks), second intervention which is crossover of first intervention was started during the next 16 weeks. Anthropometric measurements and biochemical analyses were done at the beginning and the end of each intervention (0, 16, 22, and 38 weeks of trial). Habitual diet was randomly observed using 3-day diet record once during each phase.
Investigators expected to evaluate 1)effects of walnut ingestion on reverting metabolic syndrome to normal status especially by reducing waist circumference and improving serum levels of triglyceride and high-density lipoprotein, 2)beneficial effects of daily walnut consumption on changes of body composition in the subjects with metabolic syndrome, and 3)regulatory effects of daily walnut intake on inflammatory markers and diabetic markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •at least three out of five metabolic syndrome components
- •waist circumference (WC) >90 cm for men and >80 cm for women
- •hypertension (DBP ≥85 and <110 mm Hg)
- •hyperglycemia (≥100 mg/dL)
- •elevated plasma TG concentrations (≥150 mg/dL)
- •decreased plasma HDL-C concentrations (<40 mg/dL for men and <50 mg/dL for women)
排除标准
- •the presence of morbid obesity (BMI ≥40)
- •the use of any medication for the control of blood pressure, glucose, or lipid metabolism
- •a medical history of hypocaloric diet consumption within the past year
- •gastrointestinal tract disorders
- •post-menopausal women
研究组 & 干预措施
Control-Walnut
干预措施: food (Other)
Walnut-Control
干预措施: food (Other)
结局指标
主要结局
changes of blood glucose level
时间窗: after 16 weeks of daily walnut consumption
Blood glucose levels (mg/dL) were measured using blood glucose monitor and test stripts from the finger tip.
changes of blood triglyceride level
时间窗: after 16 weeks of daily walnut consumption
Serum triglycerides (mg/dL) levels were measured by an enzymatic-colorimetric method.
changes of blood pressure
时间窗: after 16 weeks of daily walnut consumption
Blood pressure (mmHg) was measured on the right arm using an up-load blood pressure monitor with participants in a comfortably seated position after at least a 5-minute rest.
changes of waist circumference
时间窗: after 16 weeks of daily walnut consumption
Waist circumferences (cm) were obtained at the midpoint between the lowest rib and the iliac crest and rounded to the nearest 0.1 cm after inhalation and exhalation.
changes of blood high-density lipoprotein cholesterol levels
时间窗: after 16 weeks of daily walnut consumption
High density lipoprotein cholesterol (mg/dL) levels were determined by a homogeneous enzymatic-colorimetric method.
次要结局
- changes of serum apolipoprotein B level(after 16 weeks of daily walnut consumption)
- changes of serum leptin level(after 16 weeks of daily walnut consumption)
- changes of low-density lipoprotein cholesterol level(after 16 weeks of daily walnut consumption)
- changes of total cholesterol level(after 16 weeks of daily walnut consumption)
- changes of serum adiponectin level(after 16 weeks of daily walnut consumption)
- changes of serum insulin level(after 16 weeks of daily walnut consumption)
