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临床试验/NCT00874666
NCT00874666Unknown1 期

Allicin Bioavailability of Garlic Products

Silliker, Inc.1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2009年4月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
入组人数
12
试验地点
1
主要终点
Breath allyl methyl sulfide

研究概览

简要总结

This study will measure the bioavailability of allicin, the main active compound of garlic, from garlic supplements and garlic foods (raw, cooked, processed) so that

  • supplement manufacturers and clinical investigators know how supplements need to be made and consumed to obtain high bioavailability
  • consumers can know how garlic can be prepared to obtain any established health benefits of garlic.

详细描述

The bioavailability of allicin, the main active compound of garlic, from garlic supplements and garlic foods is highly questionable and unpredictable from in vitro tests, due to dependence upon alliinase activity under conditions that challenge alliinase activity (heat, gastric acid, intestinal proteases). It is likely that garlic supplement manufacturing procedures and coatings, meal conditions when supplements are consumed (high or low protein), and garlic food preparation conditions (temperature, surface area) will greatly affect allicin bioavailability. Such variability may account for some of the many conflicts seen in clinical trials on cardiovascular disease risk factors.

To resolve these issues, this study will determine the actual bioavailability of allicin from several types of garlic supplements and garlic foods under various conditions. Bioavailability will be determined by measuring the area under the 32-hour curve for breath concentrations of allyl methyl sulfide, the main metabolite allicin.

研究设计

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

入排标准

年龄范围
18 Years 至 72 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •in good health (self-judged)
  • •BMI (body mass index): 19-32 kg/m2
  • •not planning to move out of the area in the next year
  • •willing to abstain from consuming garlic and onion and foods that contain them for two days prior to and during each test (diet restrictions)
  • •able to deliver bags of breath to the research facility five times in two days
  • •willing to eat whole wheat tuna sandwiches

排除标准

  • •known serious health problems: diabetes, heart disease, active neoplasms, renal or liver disease, hyper- or hypothyroidism, breathing disorders, gastroesophageal reflux disease (GERD), gastrointestinal disease (absorption interference)
  • •known allergy to garlic or wheat
  • •tobacco user
  • •excessive alcohol intake (³2 drinks/day, self-reported)
  • •unable to speak English well

研究组 & 干预措施

1

Active Comparator

Positive control with 100% allicin bioavailability

干预措施: crushed garlic clove (Other)

2

Experimental

garlic powder tablet

干预措施: garlic powder tablet (Dietary Supplement)

结局指标

主要结局

Breath allyl methyl sulfide

时间窗: 1-32 hours

次要结局

未报告次要终点

研究者

申办方类型
Industry

研究点 (1)

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