The Effects of the Food Preservative Propionic Acid in Post-prandial Metabolism (Walnut)
Pilot Study to Study the Effects of the Food Preservative Calcium Propionate on Postprandial Hormonal and Metabolic Milieu
Propionic acid (PA) is used as a preservative in foods such as cheeses, baked goods, or additive for artificial fruit flavors. The U.S. Environmental Protection Agency considers it safe and therefore, has no limitation on its use. Since PA has been shown before to serve as a substrate for glucose production in the liver, the purpose of this study is to find out if PA intake causes changes in levels of glucose, insulin and other important hormones following a meal.
This research study will compare PA to placebo. The placebo looks exactly like the active substance, but it does not contain any active agent (PA). Placebos are used in research studies to see if the results are due to the study drug or to other reasons.
The investigators plan to have 20 subjects take part in this study at the Brigham and Women's Hospital (BWH).
研究概览
详细说明
-To test whether PA, added as food supplement to humans, results in altered post-prandial metabolism. The investigators propose to conduct a double-blind, randomized, placebo controlled, cross-over study in which blood levels of metabolites and hormones will be measured in healthy volunteers following a mixed meal test without or with PA.
Study design:
This is a double-blind, randomized, placebo controlled, cross-over study. Twenty volunteers who meet the inclusion/exclusion criteria will be randomized into two groups, provided with a mixed meal without or with calcium proprionate (also known as E282). A week later, participants will be provided with a mixed meal again, following cross-over of the groups. Blood will be collected at baseline, and every 30 minutes for 4 hours.
Study Subjects:
20 healthy male and female volunteers (ages 18 to 65 years) with a body mass index (BMI) of 20 to <30 Kg/m2.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02115
- 招聘中
- Brigham and Women's Hospital
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首席研究员：
- Amir Tirosh, MD PhD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 18-65 years
- Good health as evidenced by history and physical exam
- BMI: 20-29.9 kg/m2
Exclusion Criteria:
- Fasting plasma glucose >110 mg/dL
- HbA1c >6.0%
- Significant current illness other than treated hypothyroidism
- BP >135/85 or systolic BP <90 mm Hg
- Hepatic disease (transaminase > 3 times normal)
- Renal impairment (Creatinine clearance <60 ml/min)
- History of drug or alcohol abuse
- Participation in any other concurrent clinical trial
- Pregnant women
- History of food allergies.
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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安慰剂比较：Calcium propionate
Addition of calcium propionate (PA arm) in a capsule (1000 mg) consumed together with a mixed meal of 500 kCal in the morning following an overnight fast.
Blood is taken at baseline and every 30 minutes for 4 hours.
This arm is compared to a placebo capsule (following identical protocol).
Following a washout period of a week, the arms will be crossed over and the PA arm participants will repeat the same protocol in the 'placebo arm'.
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安慰剂比较：Placebo
Addition of placebo (PA arm) in a capsule consumed together with a mixed meal of 500 kCal in the morning following an overnight fast.
Blood is taken at baseline and every 30 minutes for 4 hours.
This arm is compared to the PA arm (PA, 1000 mg in a capsule).
Following a washout period of a week, the arms will be crossed over and the PA arm participants will repeat the same protocol in the 'placebo arm', and vice versa.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Post prandial insulin levels
大体时间：During 4 hours after consumption of a meal
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During 4 hours after consumption of a meal
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合作者和调查者
调查人员
- 首席研究员：Amir Tirosh, MD PhD、Brigham and Women's Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2013P001197
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.
Calcium propionate的临床试验
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Aristotle University Of ThessalonikiHellenic Society of Hypertension完全的