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临床试验/NCT00593307
NCT00593307已完成不适用

The Effects of Low and High Glycemic Index Foods and Protein on Glycemic Response and Hunger

Temple University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2006年1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
入组人数
24
试验地点
1
主要终点
To compare the effects of breakfast meals containing low GI and high GI foods on glucose and insulin responses

研究概览

简要总结

The overall objective is to investigate the effects of low and high glycemic index (GI) meals varying in protein content on plasma glucose and insulin response, subjective ratings of hunger, and subsequent food intake in twenty healthy, sedentary, overweight and obese men and women between the ages of 21-65.

详细描述

Each individual will participate separately in four testing sessions. Each testing session will last for approximately 5 hours and will be separated by a minimum of one week. Participants will arrive at the Temple University GCRC or CORE at either 7:30 a.m. or 8:30 a.m. after an overnight fast (10-12 hours) to ensure that all participants are in the same metabolic state. Upon arrival the experimenter will ask participants to complete a pre-session questionnaire and rate their feelings of hunger and satiety on a visual analog scale (VAS). An indwelling catheter will be inserted in an antecubital vein by the study nurse and a baseline blood sample will be obtained for measurement of glucose and insulin concentrations. Glucose will be measured by the glucose oxidase method using a glucose analyzer and insulin will be measured by radioimmunoassay.

One of four isocaloric meals (see example below), varying in macronutrient content and GI value of foods, will be administered in random order at either 8:00 a.m. or 9:00 a.m. Energy density will be controlled. The meal and 8 ounces of water will be consumed within fifteen minutes. A short visual analog questionnaire will be distributed at the conclusion of the meal to rate the meal consumed. Blood samples will be taken 15 minutes after food consumption and at 30 minute intervals (i.e., 30, 60, 90, 120, 150, 180, 210, and 240 minutes) over four hours following administration of the meal. Four milliliters of blood will be collected at each time point (via indwelling catheter), resulting in a total of 40 milliliters of blood collected at each study session and 160 milliliters (i.e., 40 ml x 4 testing sessions) within an 8 week time period. Participants will be asked to rate their feelings of hunger at these time points. Following the last blood sample, participants will be given the opportunity to consume food ad libitum from a buffet style lunch. Based on known serving sizes and measurements of unconsumed food, the amount of food eaten and its associated energy content will be determined.

研究设计

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

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Men and women between the ages of 21-65 with a BMI of 25-40(kg/m2)

排除标准

  • •Individuals who are currently dieting or restricting food intake and who report pre-existing health afflictions such as diabetes, use of prescription medications, use of appetite suppressants, or regular tobacco use will be excluded from the study as they may affect appetite or impact the dependent measures of this study.

研究组 & 干预措施

Low GI

Experimental

low GI breakfast

干预措施: Low GI (Other)

Low GI -low carb

Experimental

Low GI and Low carb breakfast

干预措施: Low GI Low Carb (Other)

High GI

Experimental

High GI breakfast

干预措施: high GI (Other)

High GI Low Carb

Experimental

high GI low carb breakfast

干预措施: High GI Low carb (Other)

结局指标

主要结局

To compare the effects of breakfast meals containing low GI and high GI foods on glucose and insulin responses

时间窗: post

次要结局

  • To examine the effects of low and high GI meals on subjective ratings of hunger and subsequent food intake(post)
  • To compare the effects of high protein meals containing either low or high GI foods with high carbohydrate meals containing either low or high HI food on glucose and insulin response, subjective ratings of hunger, and subsequent food intake.(post)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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