Colorectal Cancer
Conditions
Keywords
ginger, Zingiber officinale, Cancer Risk Reductive, Eicosanoids, Colorectal Cancer, Inflammation
Brief 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.
Interventions
DRUGGinger Root Extract (Pure Encapsulations)
2.0 g per day (10:1 extract)
DIETARY_SUPPLEMENTPlacebo Capsule
2.0 g per day
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate Whether 2.0g of Ginger Taken Daily, Standardized to 5%-Gingerols for Four Weeks Will Result in Bioactive Levels in Colonic Tissue Sufficient to Reduce Mucosal Prostaglandin E2 (PGE2), a Marker of Cyclooxygenase Function Versus Placebo. | Baseline and day 28 | % Change between baseline and day 28 in PGE2 levels standardized by protein |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ginger Root Extract Ginger Root Extract (Pure Encapsulations) : 2.0 g per day (10:1 extract) | 16 |
| Lactose Capsule Placebo Capsule : 2.0 g per day | 17 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Ginger Root Extract | Lactose Capsule | Total |
|---|---|---|---|
| Age, Continuous | 34.5 years STANDARD_DEVIATION 13.1 | 33.4 years STANDARD_DEVIATION 10.1 | 34.0 years STANDARD_DEVIATION 11.1 |
| Region of Enrollment United States | 16 participants | 17 participants | 33 participants |
| Sex: Female, Male Female | 9 Participants | 8 Participants | 17 Participants |
| Sex: Female, Male Male | 7 Participants | 9 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 14 | 7 / 16 |
| serious Total, serious adverse events | 0 / 14 | 0 / 16 |
Outcome results
Primary
Evaluate Whether 2.0g of Ginger Taken Daily, Standardized to 5%-Gingerols for Four Weeks Will Result in Bioactive Levels in Colonic Tissue Sufficient to Reduce Mucosal Prostaglandin E2 (PGE2), a Marker of Cyclooxygenase Function Versus Placebo.
% Change between baseline and day 28 in PGE2 levels standardized by protein
Time frame: Baseline and day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lactose Capsule | Evaluate Whether 2.0g of Ginger Taken Daily, Standardized to 5%-Gingerols for Four Weeks Will Result in Bioactive Levels in Colonic Tissue Sufficient to Reduce Mucosal Prostaglandin E2 (PGE2), a Marker of Cyclooxygenase Function Versus Placebo. | 31.9 percentage of change from baseline | Standard Deviation 89.8 |
| Ginger Root Extract | Evaluate Whether 2.0g of Ginger Taken Daily, Standardized to 5%-Gingerols for Four Weeks Will Result in Bioactive Levels in Colonic Tissue Sufficient to Reduce Mucosal Prostaglandin E2 (PGE2), a Marker of Cyclooxygenase Function Versus Placebo. | -6.7 percentage of change from baseline | Standard Deviation 51.6 |
p-value: <0.05t-test, 2 sided