Ginger for Colorectal Cancer Prevention
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Ginger Root Extract (Pure Encapsulations); Placebo Capsule
Intervention description: 2.0 g per day (10:1 extract); 2.0 g per day
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ginger; Zingiber officinale; Cancer Risk Reductive; Eicosanoids; Colorectal Cancer; Inflammation

Summary:

      The purpose of this study is to determine if ginger root extract when taken daily for 28 days
      is able to decrease levels of inflammatory chemicals called eicosanoids in the gut tissue of
      people who are at normal risk and those at increased of developing colorectal cancer compared
      to people taking placebo.
    

Eligibility 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