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Glycemic Index and Brain Function

2012年2月1日 更新者:David Alsop、Beth Israel Deaconess Medical Center

The Effects of Dietary Glycemic Index on Brain Function

The investigators propose examine the effects of the dietary factor glycemic index (GI) on brain areas that control food intake and hunger. This knowledge could help design dietary approaches that decrease hunger, and thus promote new weight loss strategies.

研究概览

地位

完全的

条件

详细说明

Most individuals have great difficulty following reduced calorie diets because they experience increased hunger. This process is regulated by specific brain areas. Though many psychological and environmental factors are involved, physiological effects of diet may have a significant impact. The postprandial rise in blood glucose, quantified by the glycemic index (GI), is of particular interest. High GI meals elicit hormonal events that limit availability of metabolic fuels, causing hunger and overeating, especially in people with high insulin secretion.

Our aim is to examine how postprandial changes after high versus low GI meals affect hunger and brain function in areas of intake control. Specifically, we speculate that obese individuals will demonstrate functional changes in brain areas of intake control and increased hunger after a high versus low GI meal.

We will recruit obese, young adults and quantify their insulin secretion during a 2-hour oral glucose tolerance test. A brief practice MRI session will serve to familiarize the subjects with the scanning process. During the two test sessions, standardized test meals with high versus low GI will be given in a randomized, blinded cross-over design. Serial blood levels of hormones, metabolic fuels, and metabolites will be correlated with perceived hunger, and a perfusion MRI scan will be performed to assess brain activation during the late postprandial phase, at the nadir of blood sugar and insulin levels (4 hours postprandial).

This work will inform an integrated physiological model relating peripheral postprandial changes to brain function and hunger. In addition, findings may provide evidence of a novel diet-phenotype, in which baseline clinical characteristics can be used to predict which weight loss diet will work best for a specific individual. Metabolite profiling might shed light on the mechanisms linking diet composition to brain function, and provide feasible clinical markers of the identified phenotype to facilitate translation into practice.

研究类型

介入性

注册 (实际的)

12

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • Beth Israel Deaconess Medical Center
      • Boston、Massachusetts、美国、02115
        • Children's Hospital Boston
      • Boston、Massachusetts、美国、02215
        • Brigham and Women's Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 35年 (成人)

接受健康志愿者

是的

有资格学习的性别

男性

描述

Inclusion criteria

  1. Males age 18 to 35 years
  2. BMI less than or equal to 25 for age and gender

Exclusion criteria

  1. weight > 300 lbs
  2. largest body circumference > 144cm
  3. body shape incompatible with MRI scanner or equipment
  4. MRI exclusion criteria
  5. large fluctuations in body weight (5% over preceding 6 months, 2.5% during the study)
  6. known medical problems that may affect metabolism or hormones
  7. diabetes mellitus (fasting plasma glucose ≥126 mg/dL)
  8. other abnormal laboratory screening tests
  9. taking any medications or dietary supplements that might affect body weight, appetite, or energy expenditure
  10. smoking or illicit substance abuse
  11. high levels of physical activity (>30 minutes per day, > 4days per week)
  12. currently following a weight loss diet
  13. allergies or intolerance to eggs, vanilla extract, equal, canola oil, milk, cornstarch, corn syrup

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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:四人间

武器和干预

参与者组/臂
干预/治疗
有源比较器:Low GI
Subjects will be instructed to consume a liquid test meal with a low GI over 5 minutes after baseline laboratory evaluations. The low and high GI meal contain similar amounts of milk, oil, dried egg whites, equal, and vanilla extract. The low GI meal corn-starch as a carbohydrate. Both meals have similar macronutrient composition (60% carbohydrate, 15% protein, 25% fat), micronutrient profiles, physical properties, palatability and sweetness. The high vs. low GI meals have a predicted difference in GI of 90 vs. 40, and consistent with this prediction, a pilot study in obese young adults found a 2.2-fold difference in glycemic response (p<0.001). The test meals will provide 25% of individual daily energy requirements.
实验性的:High GI
Subjects will be instructed to consume a liquid test meal with a high GI over 5 minutes after baseline laboratory evaluations. The low and high GI meal contain similar amounts of milk, oil, dried egg whites, equal, and vanilla extract. The high GI meal contains corn-syrup as a carbohydrate. Both meals have similar macronutrient composition (60% carbohydrate, 15% protein, 25% fat), micronutrient profiles, physical properties, palatability and sweetness. The high vs. low GI meals have a predicted difference in GI of 90 vs. 40, and consistent with this prediction, a pilot study in obese young adults found a 2.2-fold difference in glycemic response (p<0.001). The test meals will provide 25% of individual daily energy requirements.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Blood Flow in Brain Areas of Intake Control.
大体时间:4 hours postprandial
4 hours postprandial

次要结果测量

结果测量
措施说明
大体时间
Subjective Hunger Rating
大体时间:Every 30 minutes for 5 hours.
Every 30 minutes for 5 hours.
Blood Glucose Level
大体时间:Every 30 minutes for 5 hours.
Every 30 minutes for 5 hours.
Blood Insulin Level
大体时间:Every 30 minutes for 5 hours
Every 30 minutes for 5 hours
Blood Glucagon Level
大体时间:Every 30 minutes for 5 hours.
Every 30 minutes for 5 hours.
Blood Growth Hormone Level
大体时间:Every 30 minutes for 5 hours.
Every 30 minutes for 5 hours.
Blood Epinephrine Level
大体时间:Every 30 minutes for 5 hours.
Every 30 minutes for 5 hours.
Blood Fatty Acids Level
大体时间:Every 30 minutes for 5 hours.
measuring metabolite profiles
Every 30 minutes for 5 hours.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Belinda S Lennerz, MD, PhD、Boston Children's Hospital
  • 首席研究员:David Alsop, PhD、Beth Israel Deaconess Medical Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年2月1日

初级完成 (实际的)

2011年6月1日

研究完成 (实际的)

2011年9月1日

研究注册日期

首次提交

2010年2月5日

首先提交符合 QC 标准的

2010年2月5日

首次发布 (估计)

2010年2月8日

研究记录更新

最后更新发布 (估计)

2012年2月2日

上次提交的符合 QC 标准的更新

2012年2月1日

最后验证

2012年2月1日

更多信息

与本研究相关的术语

其他研究编号

  • RA-003

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Low GI的临床试验

3
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