Healthy Eating for Colon Cancer Prevention
Study Details
Study Description
Brief Summary
The purpose of this study is to help develop diets for colon cancer prevention. This study will compare the Mediterranean diet to the Healthy People 2010 diet in 120 subjects with increased risk for colorectal cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
There is substantial epidemiological evidence that dietary patterns influence colorectal cancer risk. The associations of any particular nutrient with increased or decreased risks, however, may not be due to that nutrient per se but to the whole foods that are rich in that nutrient. Simultaneously, reducing intakes of foods associated with increased risk while increasing foods identified in preventive diets may be the best approach for prevention. The Cretan-Mediterranean diet in particular appears to hold great promise for cancer prevention. The major components of the traditional Cretan diet have been associated with decreased colon cancer. Relative to the American diet, this diet has lower n-6/n-3 and n-6/n-9 fatty acid ratios, lower polyunsaturated fatty acid intake, lower red meat intake, and higher intakes of plant-based foods and monounsaturated fatty acids.
The hypothesis of this study is that adherence to a Mediterranean type of diet will result in a decrease in n-6 fatty acids and increased n-3 and n-9 fatty acids in human colorectal mucosa. This together with aspects of the diet such as increased intakes of fruits and vegetables, is expected to modulate eicosanoid metabolism and epithelial proliferation in normal mucosa. 120 persons, with an increased risk for colorectal cancer, will be randomized to a modified Mediterranean diet or a Healthy People 2010 diet for six months.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 1 Healthy Eating Healthy People 2010 Diet using an exchange list |
Behavioral: 1 Healthy Eating
6 months telephone counseling
|
| Experimental: 2 Mediterranean Mediterranean Diet using an exchange list |
Behavioral: 2 Mediterranean
6 months telephone counseling
|
Outcome Measures
Primary Outcome Measures
- Adherence to Dietary Goals [6 months]
Percentage of participants who met 70% of diet goals as outlined in the exchange list
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Prior adenomatous polyp.
-
Prior resected early (Dukes A, B, or C) colon cancer. With the exception of curative surgery for small lesions, such as endoscopically removed cancers, eligible subject will be at least two years post treatment for colorectal cancer.
-
A history of colon cancer in a primary relative or in two secondary relatives.
-
Good general health and not expecting major lifestyle changes in the next 6 months.
-
Age 21 or older.
-
Not expecting a change in hormonal therapies over the next 6 months.
-
Taking less than 81 mg/day or 325 mg aspirin every other day for prevention of cardiovascular disease.
-
Dietary intake that is within the usual range for a typical American diet.
-
Read and understand English.
-
Sign the consent and willing to comply with all study procedures.
-
Have a telephone.
-
At least 5 years post any type of treatment for any other cancer except cancers that were removed completely by surgery and no other treatment was undergone.
-
No more than occasional use (< 25% of the time) of pain medications and willing to take only regular strength acetaminophen while on study except for 81 mg/day or 325 mg every other day of aspirin for prevention of cardiovascular disease.
Exclusion Criteria:
-
On medically prescribed diets or following a diet that would require extensive counseling to correct nutritional deficiencies.
-
Taking supplements or medications that might obscure our ability to detect an effect of diet (eg. lipid-lowering medications, insulin, fish oils, mega-vitamins).
-
Are pregnant or lactating or planning to get pregnant.
-
Previous diagnosis of HIV or hepatitis C.
-
Have cancer at the present time.
-
Being treated with or taking therapies or supplements that could obscure our ability to detect diet effects, such as fish oils.
-
Previous advanced cancer (Duke's D) or hereditary and familial polyposis (HNPCC/FAP) because the latter are rare conditions with unique etiology.
-
Due to the effects of inflammation on biomarker levels in mucosa, persons with Crohn's disease or inflammatory bowel disease will be excluded.
-
Persons with BMI < 18.5 or > 35 kg/m2 since low BMI could indicate eating disorders and high BMI values, above the midpoint of the obesity range, could indicate more prevalent health problems and these persons can be more difficult to counsel.
-
Persons taking very high levels of aspirin or non-steroidal anti-inflammatory agents (NSAIDS) for conditions such as arthritis, a chronic inflammatory condition, will be excluded since it will preclude our ability to detect a further decrease in PGE2.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- University of Michigan
Investigators
- Principal Investigator: Zora Djuric, Ph.D., University of Michigan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUM00007622
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | 1 Healthy Eating | 2 Mediterranean |
|---|---|---|
| Arm/Group Description | Healthy People 2010 Diet Healthy People 2010 Diet through dietary counseling: 6 months telephone counseling | Mediterranean Diet Mediterranean Diet through dietary counseling: 6 months telephone counseling |
| Period Title: Overall Study | ||
| STARTED | 61 | 59 |
| COMPLETED | 46 | 47 |
| NOT COMPLETED | 15 | 12 |
Baseline Characteristics
| Arm/Group Title | 1 Healthy Eating | 2 Mediterranean | Total |
|---|---|---|---|
| Arm/Group Description | Healthy People 2010 Diet using an exchange list 1 Healthy Eating: 6 months telephone counseling | Mediterranean Diet using an exchange list 2 Mediterranean: 6 months telephone counseling | Total of all reporting groups |
| Overall Participants | 61 | 59 | 120 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
51
(13)
|
55
(10)
|
53
(12)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
43
70.5%
|
43
72.9%
|
86
71.7%
|
| Male |
18
29.5%
|
16
27.1%
|
34
28.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
1
1.7%
|
1
0.8%
|
| Not Hispanic or Latino |
61
100%
|
58
98.3%
|
119
99.2%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
1
1.6%
|
0
0%
|
1
0.8%
|
| Asian |
2
3.3%
|
1
1.7%
|
3
2.5%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
2
3.3%
|
6
10.2%
|
8
6.7%
|
| White |
55
90.2%
|
52
88.1%
|
107
89.2%
|
| More than one race |
1
1.6%
|
0
0%
|
1
0.8%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
61
100%
|
59
100%
|
120
100%
|
Outcome Measures
| Title | Adherence to Dietary Goals |
|---|---|
| Description | Percentage of participants who met 70% of diet goals as outlined in the exchange list |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 1 Healthy Eating | 2 Mediterranean |
|---|---|---|
| Arm/Group Description | Healthy People 2010 Diet Healthy People 2010 Diet through dietary counseling: 6 months telephone counseling | Mediterranean Diet Mediterranean Diet through dietary counseling: 6 months telephone counseling |
| Measure Participants | 61 | 59 |
| Number [percentage of participants meeting goals] |
89
145.9%
|
85
144.1%
|
Adverse Events
| Time Frame | 5 years | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | 1 Healthy Eating | 2 Mediterranean | ||
| Arm/Group Description | Healthy People 2010 Diet Healthy People 2010 Diet through dietary counseling: 6 months telephone counseling | Mediterranean Diet Mediterranean Diet through dietary counseling: 6 months telephone counseling | ||
All Cause Mortality |
||||
| 1 Healthy Eating | 2 Mediterranean | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| 1 Healthy Eating | 2 Mediterranean | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/61 (0%) | 2/59 (3.4%) | ||
| Gastrointestinal disorders | ||||
| surgery | 0/61 (0%) | 0 | 1/59 (1.7%) | 1 |
| Psychiatric disorders | ||||
| bipolar relapse | 0/61 (0%) | 0 | 1/59 (1.7%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| 1 Healthy Eating | 2 Mediterranean | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 15/61 (24.6%) | 18/59 (30.5%) | ||
| Infections and infestations | ||||
| various minor conditions | 15/61 (24.6%) | 15 | 18/59 (30.5%) | 18 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Zora Djuric |
|---|---|
| Organization | University of Michigan |
| Phone | 734-615-6210 |
| zoralong@umich.edu |
- HUM00007622