Effects of Daily Walnut Intake Among the Subjects With Metabolic Syndrome
Effects of Daily Walnut Intake Among the Subjects With Metabolic Syndrome in South Korea
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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Seoul、大韩民国、07327
- ICAN Nutrition Education and Research
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria: 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)
Exclusion Criteria:
- 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
- smokers
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Walnut-Control
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45 g of walnut / iso-caloric white bread
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实验性的：Control-Walnut
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45 g of walnut / iso-caloric white bread
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
changes of waist circumference
大体时间：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.
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after 16 weeks of daily walnut consumption
|
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changes of blood triglyceride level
大体时间：after 16 weeks of daily walnut consumption
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Serum triglycerides (mg/dL) levels were measured by an enzymatic-colorimetric method.
|
after 16 weeks of daily walnut consumption
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changes of blood high-density lipoprotein cholesterol levels
大体时间：after 16 weeks of daily walnut consumption
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High density lipoprotein cholesterol (mg/dL) levels were determined by a homogeneous enzymatic-colorimetric method.
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after 16 weeks of daily walnut consumption
|
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changes of blood pressure
大体时间：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.
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after 16 weeks of daily walnut consumption
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changes of blood glucose level
大体时间：after 16 weeks of daily walnut consumption
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Blood glucose levels (mg/dL) were measured using blood glucose monitor and test stripts from the finger tip.
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after 16 weeks of daily walnut consumption
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
changes of total cholesterol level
大体时间：after 16 weeks of daily walnut consumption
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Serum total cholesterol levels (ml/dL) were measured by an enzymatic-colorimetric method.
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after 16 weeks of daily walnut consumption
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changes of serum apolipoprotein B level
大体时间：after 16 weeks of daily walnut consumption
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Serum apolipoprotein B (ml/dL) was measured using a turbidimetric immunoassay.
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after 16 weeks of daily walnut consumption
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changes of serum adiponectin level
大体时间：after 16 weeks of daily walnut consumption
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Blood adiponectin (ug/mL) levels were measured using ELISA.
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after 16 weeks of daily walnut consumption
|
|
changes of serum leptin level
大体时间：after 16 weeks of daily walnut consumption
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Blood leptin (ug/mL) levels were measured using ELISA.
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after 16 weeks of daily walnut consumption
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changes of serum insulin level
大体时间：after 16 weeks of daily walnut consumption
|
Serum insulin (μU/mL) was measured with a commercially available kit, the ultrasensitive insulin ELISA kit using an Epoch microplate spectrophotometer.
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after 16 weeks of daily walnut consumption
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changes of low-density lipoprotein cholesterol level
大体时间：after 16 weeks of daily walnut consumption
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Low-density lipoprotein cholesterol levels (ml/dL) were determined by a homogeneous enzymatic-colorimetric method.
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after 16 weeks of daily walnut consumption
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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