TRIAL OF AN ENCAPSULATED GINGER STANDARDIZED TO 5%-6-GINGEROLS

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. In this study, we want to find the highest dose of ginger that a person can take before they have a side-effect. We will check how safe ginger is at all doses. Also, we will look at how ginger can be detected in blood after it is taken as a pill. In our study, we will test six different doses of ginger. There will be three people at each dose, plus six people at the highest dose. The six doses of ginger are 100 mg, 250 mg, 500 mg, 1000 mg, 1500 mg, and 2000 mg. If one person has a bad side-effect to ginger we will stop the study. The ginger dose that is lower than the one that caused the bad side-effect will be the highest dose of ginger that is safe. If one person has a small side-effect to ginger three more people will be added to the study at the same dose that caused the small side-effect. Also, if two people have a small side-effect at the same dose of ginger we will stop the study. The ginger dose that caused the small side-effect will be highest dose of ginger that is safe. People who can be in this study need to be at least 18 years old, have no illnesses and taking no medications, except for birth control. Before starting the study everyone who is in the study will sign a consent form, which explains what will happen during the study. Everyone in the study will stay at the University of Michigan Hospital for 10 hours after taking their ginger dose. You must fast for 8 hours before your 10 hour stay at the University of Michigan Hospital. One tablespoon of blood will be taken before the ginger dose and then at 15 minutes, 30 minutes, forty-five minutes, one hour, two hours, four hours, six hours, eight hours, and ten hours after taking the ginger dose. Also, everyone in the study will return to the hospital at 24, 48 and 72 hour to have their blood drawn.