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临床试验/NCT01883700
NCT01883700Unknown2 期

Variability of Acute Response to Equicaloric Test Meals Varying in Glycemic Index and Glycemic Load on Postprandial Glycemia, Arterial Stiffness and Blood Pressure in Healthy Adults

Unity Health Toronto1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2010年8月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
入组人数
21
试验地点
1
主要终点
To measure postprandial changes in augmentation index (AIx) to determine the acute effect of high- and low-GI and high- and low-GL meals on arterial stiffness.

研究概览

简要总结

This study examines the effects of carbohydrate type (high- or low-Glycemic Index (GI)) and amount (high- or low-Glycemic Load (GL)) have on blood glucose levels, blood pressure and arterial stiffness in healthy individuals. It will also determine whether subjective ratings such as test meal palatability and hunger are related to changes in blood glucose. The investigators hypothesize that: (1) High-GI meals, regardless of GL, will increase arterial stiffness; low-GI meals, regardless of GL, will have a neutral or lowering effect on arterial stiffness (augmentation index). (2) High-GI meals, regardless of GL, will have an elevating effect on both central and peripheral blood pressures. (3) The incremental area under the curve for blood glucose will show most significant differences between high-GI, high-GL and low-GI, low-GL meals at 30 and 90 min.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •age 18 - 75 years
  • •BMI 18 - 25 kg/m2
  • •brachial systolic blood pressure < 140 mmHg
  • •brachial diastolic blood pressure < 90 mmHg

排除标准

  • •primary hypertension
  • •allergy or sensitivity to any foods to be used in the study
  • •gastrointestinal disorders
  • •chronic kidney disease
  • •liver disease
  • •hepatitis
  • •estrogen-sensitive cancer
  • •heavy alcohol use
  • •sleep apnea
  • •bleeding disorders
  • •planned surgery (within time frame of study)
  • •Congestive Heart Failure
  • •coronary revascularization
  • •peripheral vascular disease and/or coronary/cerebrovascular events within the previous 6 months
  • •positive HIV diagnosis
  • •prescription of anti-depressants, anti-hypertensives, anti-coagulant medications, diuretics, sympathomimetics, herbal therapies, vitamin or K supplementation, medication affecting NO synthesis
  • •chronic use or prescription of NSAIDs
  • •women of childbearing potential must not be pregnant or breastfeeding

研究组 & 干预措施

Low-GI, High-GL Meal

Experimental

Boiled Pasta

干预措施: Boiled Pasta (Other)

Low-GI, High GL Meal

Experimental

Boiled Chickpeas with Oil

干预措施: Boiled Chickpeas with Oil (Other)

High-GI, High-GL Meal

Experimental

Instant Mashed Potatoes

干预措施: Instant Mashed Potatoes (Other)

High-GI, Low-GL Meal

Experimental

Instant Mashed Potatoes with Egg Whites

干预措施: Instant Mashed Potatoes with Egg Whites (Other)

结局指标

主要结局

To measure postprandial changes in augmentation index (AIx) to determine the acute effect of high- and low-GI and high- and low-GL meals on arterial stiffness.

时间窗: 4 separate mornings, measurements taken at baseline and at 60, 120, 180 and 240 minutes

次要结局

  • To determine the acute effect of high- and low-GI and high- and low- GL meals on central and peripheral blood pressure(4 separate mornings, measurements taken at baseline, 60, 120, 180 and 240 minutes.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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