Healthy Volunteers Clinical Trial
Official title:
2-Hydroxybenzylamine: Multiple Dosing Study in Healthy Humans
The purpose of this study is to test how well people tolerate a new dietary ingredient called 2-HOBA and how it is metabolized in the body. 2-HOBA is a compound that occurs naturally in buckwheat seeds. This dietary ingredient has been used in animal studies, and single doses have been tolerated well when given to a small group of healthy people. In this study we will test how well people tolerate taking 2-HOBA over 2 weeks and how it is metabolized by the body.
Consenting healthy volunteers between 18 and 59 years old with no morbidity, including males,
and females who are not pregnant will be recruited for the study. Eighteen volunteers will be
studied with a reasonable sampling of ethnicities from the Nashville area, and an effort will
be made to recruit equal numbers of males and females. The study will be conducted by the
Vanderbilt Clinical Research Center (CRC).
Based upon single dose pharmacokinetics, two multiple dose regimens will be studied to
determine the safety, accumulation kinetics, and pharmacodynamic effects of multiple daily
doses administered over 2 weeks. A complete health history and physical examination will be
conducted by a physician. An EKG, baseline blood and urine sample, and vital signs will be
taken prior to supplement administration. A physician will oversee all clinical aspects of
the study and will be responsible for all trial-related medical decisions. Additionally, DNA
will be collected from the blood drawn and used to determine if there are any genetic
differences in metabolism of 2-HOBA. Volunteers will be given 3 daily doses of either placebo
or one of two levels of 2-HOBA to determine the safety, accumulation kinetics, and
pharmacodynamic effects of the multiple dose administration over a 2 week period.
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