跳至主要内容
临床试验/NCT03267901
NCT03267901已完成不适用

Effects of Daily Walnut Intake Among the Subjects With Metabolic Syndrome in South Korea

ICAN Nutrition Education and Research2 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2015年5月1日最近更新:
适应症
干预措施

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

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

Experimental

干预措施: food (Other)

Walnut-Control

Experimental

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)

研究者

发起方
ICAN Nutrition Education and Research
申办方类型
Industry
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Effects of Daily Walnut Intake Among the Subjects... | 临床试验