跳至主要内容
临床试验/NCT01656850
NCT01656850已完成不适用

The Effect of Whole Almonds on Glucoregulation, Endothelial Function, Inflammation, Lipid Profile, and Oxidative Stress in Chinese Patients With Type 2 Diabetes

Taipei Medical University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Area Under Curve of Plasma Insulin After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention

研究概览

简要总结

The purpose of the study is to examine whether almond consumption for 3 month will help Chinese patients with type 2 diabetes control blood glucose and decrease risk factors of cardiovascular disease.

详细描述

Our previous study demonstrated almonds (~60 g/d) improved lipid profile, glucoregulation, inflammation, and oxidative stress in 20 Chinese patients with type 2 diabetes mellitus (T2DM). To follow-up and expand this work with a more robust trial, the investigators propose a larger (n = 40), longer-term (90-d) investigation of the effect of almonds (~60 g/d) on adipokine regulation, endothelial function, glucoregulation, inflammation, lipid profile, and oxidative stress in Chinese patients with T2DM as compared to a placebo control. The investigators will conduct a 7-mo randomized, cross-over, placebo controlled clinical trial in which all meals will be provided to all subjects (n = 40). During the first 2 weeks (run-in period), all subjects will receive a control diet resembling a typical Taiwan diet, prepared based on the NCEP Step 2 guidelines. During the following 3 mo (Phase I), subjects will be randomized to receive either the control diet or the control diet with whole almonds (~60g/d) incorporated to replace 20% calories. After a 2-wk washout period during which all subjects will once again receive the control diet, subjects will receive the opposite diet to the one assigned during the Phase I for the other 3 months (Phase II). The caloric content of each diet will be adjusted to each subjects' energy needs to prevent any change in body weight. The following biomarkers will be determined at the baseline and end of each dietary intervention: Glucoregulation: fasted serum HbA1c, glucose and insulin, postprandial serum glucose and insulin, and urinary C-peptide; Endothelial Function: brachial artery FMD and serum nitric oxide, e-selectin, endothelial-1 (ET-1), and intracellular adhesion molecule-1 (ICAM-1); Adipokine Regulation: serum adiponectin, leptin, and resistin; Inflammation: serum high-sensitivity C-reactive protein (CRP), interleukin (IL)-6, IL-10, retinol binding protein-4 (RBP-4), and tumor necrosis factor (TNF)-α; Oxidative Stress: urinary isoprostanes (adjusted for creatinine) and serum protein carbonyls and oxidized LDL; and Lipid Profile: serum cholesterol, triglycerides, and apolipoproteins A1 and B.

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
None

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • aged between 40-70 years,
  • with BMI = 24-35 kg/m2,
  • HbA1c 6.5-9 %, and
  • regular use of oral hypoglycemic agents.

排除标准

  • Use of insulin to control blood glucose
  • Regular use of oral steroids
  • Regular use of anti-inflammatory agents (prescribed [Rx] or over-the-counter [OTC])
  • Gain or loss of larger than 5% of body weight in the last 6 months
  • CVD: coronary artery disease, left ventricular hypertrophy evidenced by echocardiogram, congestive heart failure, cerebrovascular disease, stroke, peripheral vascular disease, dysautonomia
  • Gastrointestinal: diseases, conditions, or medications influencing gastrointestinal absorption including active peptic ulcer disease, inflammatory bowel disease, treatment with acid-lowering drugs
  • Renal: chronic kidney disease due to any condition, renovascular disease, history of nephrolithiasis, diabetic nephropathy, serum creatinine > 1.5 mg/dL
  • Endocrine: disease, untreated thyroid disease, adrenal disease, pheochromocytoma, parathyroid disease, hyperuricemia
  • Rheumatologic: gout, inflammatory arthritis
  • Active treatment for cancer of any type (except basal cell carcinoma) 1 year
  • Systolic blood pressure larger than 150 mmHg, and diastolic blood pressure larger than 95 mmHg.
  • Any history of or known allergies to nuts of any kind
  • Frequent nut consumption, defined as ≥ 3 oz/wk; however, subjects who are willing to refrain from eating all nuts and nut products for 6 wk prior to their initial visit (Visit 1) may be considered eligible
  • Regular use of any dietary supplements containing vitamins, minerals, herbal or other plant-based preparations, fish oil supplements (including cod liver oil) or homeopathic remedies; however, subjects who are willing to refrain from the use of these supplements for 1 mo prior to their initial visit (Visit 1) and throughout the entire study may be considered eligible
  • Usual daily ethanol intake of larger or equal to 2 drinks (24 oz beer, 8 oz wine, 2 oz hard liquor)
  • Illicit drug use
  • Specific laboratory blood or urine analysis parameters of: creatinine larger than 1.5 mg/dL, ALT and AST larger than 1.5 nmol/L, and urinalysis - hematuria and proteinuria

结局指标

主要结局

Area Under Curve of Plasma Insulin After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention

时间窗: at the baseline and at the end of 3-month dietary intervention

The Major Nutrients of NCEP Step 2 Diet and Almond Diets

时间窗: the entire study, up to 3 months

Plasma Lipid Profiles at the Baseline and at the End of 3-month Dietary Intervention

时间窗: at the baseline and at the end of 3-month dietary intervention

The Calories of NCEP Step 2 Diet and Almond Diets

时间窗: the entire study, up to 3 months

Lipid Composition of NCEP Step 2 Diet and Almond Diets

时间窗: the entire study, up to 3 months

Body Fat Percentage at the Baseline and at the End of 3-month Dietary Intervention

时间窗: at the baseline and at the end of 3-month dietary intervention

Plasma HbA1c Level at the Baseline and the End of 3-month Dietary Intervention

时间窗: at the baseline and at the end of 3-month dietary intervention

Plasma Nitric Oxide Level at the Baseline and at the End of 3-month Dietary Intervention

时间窗: at the baseline and at the end of 3-month dietary intervention

Endothelial Function at the Baseline and at the End of 3-month Dietary Intervention

时间窗: at the baseline and at the end of 3-month dietary intervention

Body Weight at the Baseline and at the End of 3-month Dietary Intervention

时间窗: at the baseline and at the end of 3-month dietary intervention

Blood Pressure at the Baseline and at the End of 3-month Dietary Intervention

时间窗: at the baseline and at the end of 3-month dietary intervention

Plasma Fasting Glucose at the Baseline and the End of 3-month Dietary Intervention

时间窗: at the baseline and at the end of 3-month dietary intervention

Area Under Curve of Plasma Glucose After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention

时间窗: at the baseline and at the end of 3-month dietary intervention

Plasma Fasting Insulin at the Baseline and the End of 3-month Dietary Intervention

时间窗: at the baseline and at the end of 3-month dietary intervention

HOMA at the Baseline and the End of 3-month Dietary Intervention

时间窗: at the baseline and at the end of 3-month dietary intervention

Plasma Apolipoprotein Level at the Baseline and the End of 3-month Dietary Intervention

时间窗: at the baseline and at the end of 3-month dietary intervention

Plasma Protein Carbonyl Level at the Baseline and at the End of 3-month Dietary Intervention

时间窗: at the baseline and at the end of 3-month dietary intervention

Plasma Oxide LDL Level at the Baseline and at the End of 3-month Dietary Intervention

时间窗: at the baseline and at the end of 3-month dietary intervention

Urine Isoproterenol Level at the Baseline and at the End of 3-month Dietary Intervention

时间窗: at the baseline and at the end of 3-month dietary intervention

Plasma Vitamin E Level at the Baseline and at the End of 3-month Dietary Intervention

时间窗: at the baseline and at the end of 3-month dietary intervention

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jen-Fang Liu

Professor

Taipei Medical University

研究点 (1)

Loading locations...

相似试验