Inclusion Criteria

Inclusion Criteria Normal Risk:

- 18 years or older and in good health as defined by an unremarkable medical history,
physical and screening blood work (chemistry screen, complete blood count) within 60
days of study entry.

- No chronic medication use was allowed and participants could not have taken aspirin
or related NSAIDs during the study or 14 days before the first dose of the study
medication.

- Participants also had to be classified as being at normal-risk for developing
colorectal cancer. Normal-risk was defined as having: no first-degree relatives with
colon cancer diagnosed before the age of 60; no personal history of colorectal cancer
and no adenomas >1 cm in size or containing carcinoma in situ

Exclusion Criteria for both Normal and Increased Risk for Colorectal Cancer:

1. a history of peptic ulcer disease, gastrointestinal bleeding from gastric or
duodenal ulcers, or gastrin secreting tumors;

2. pregnant or lactating women;

3. history of cardiovascular disease;

4. lactose intolerance;

5. or an allergy to ginger

6. a history of familial colorectal cancer syndromes;.

Inclusion Criteria Increased Risk:

- 18 years or older and in good health as defined by an unremarkable medical history,
physical and screening blood work (chemistry screen, complete blood count) within 60
days of study entry.

- No chronic medication use was allowed and participants could not have taken aspirin
or related NSAIDs during the study or 14 days before the first dose of the study
medication.

- Participants also had to be classified as being at increased-risk for developing
colorectal cancer. Increased-risk is defined as having at least one of the
following: a first-degree relatives with colon cancer diagnosed before the age of 60;
a personal history of early stage colorectal cancer and/or no adenomas >1 cm in size
or containing carcinoma in situ