NCT00475722

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 21, 2007

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

July 8, 2015

Completed
Last Updated

September 26, 2016

Status Verified

August 1, 2016

Enrollment Period

3.5 years

First QC Date

May 17, 2007

Results QC Date

May 26, 2015

Last Update Submit

August 18, 2016

Conditions

Colon Cancer

Keywords

cancercolonpreventionhealthy eatingMediterranean dietPGE2cyclooxygenaselipoxygenaseHealthy People 2010 dietdietary prevention of colon cancer

Outcome Measures

Primary Outcomes (1)

  • Adherence to Dietary Goals

    Percentage of participants who met 70% of diet goals as outlined in the exchange list

    6 months

Study Arms (2)

1 Healthy Eating

ACTIVE COMPARATOR

Healthy People 2010 Diet using an exchange list

Behavioral: 1 Healthy Eating

2 Mediterranean

EXPERIMENTAL

Mediterranean Diet using an exchange list

Behavioral: 2 Mediterranean

Interventions

1 Healthy EatingBEHAVIORAL

6 months telephone counseling

1 Healthy Eating
2 MediterraneanBEHAVIORAL

6 months telephone counseling

2 Mediterranean

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (9)

  • Djuric Z, Ruffin MT 4th, Rapai ME, Cornellier ML, Ren J, Ferreri TG, Askew LM, Sen A, Brenner DE, Turgeon DK. A Mediterranean dietary intervention in persons at high risk of colon cancer: recruitment and retention to an intensive study requiring biopsies. Contemp Clin Trials. 2012 Sep;33(5):881-8. doi: 10.1016/j.cct.2012.05.006. Epub 2012 May 26.

    PMID: 22640923RESULT

  • Sidahmed E, Cornellier ML, Ren J, Askew LM, Li Y, Talaat N, Rapai MS, Ruffin MT, Turgeon DK, Brenner D, Sen A, Djuric Z. Development of exchange lists for Mediterranean and Healthy Eating diets: implementation in an intervention trial. J Hum Nutr Diet. 2014 Oct;27(5):413-25. doi: 10.1111/jhn.12158. Epub 2013 Sep 20.

    PMID: 24112099RESULT

  • Sen A, Ren J, Ruffin MT, Turgeon DK, Brenner DE, Sidahmed E, Rapai ME, Cornellier ML, Djuric Z. Relationships between serum and colon concentrations of carotenoids and fatty acids in randomized dietary intervention trial. Cancer Prev Res (Phila). 2013 Jun;6(6):558-65. doi: 10.1158/1940-6207.CAPR-13-0019. Epub 2013 Apr 16.

    PMID: 23592741RESULT

  • Umoh FI, Kato I, Ren J, Wachowiak PL, Ruffin MT 4th, Turgeon DK, Sen A, Brenner DE, Djuric Z. Markers of systemic exposures to products of intestinal bacteria in a dietary intervention study. Eur J Nutr. 2016 Mar;55(2):793-798. doi: 10.1007/s00394-015-0900-7. Epub 2015 Apr 24.

    PMID: 25903259RESULT

  • Djuric Z, Turgeon DK, Ren J, Neilson A, Plegue M, Waters IG, Chan A, Askew LM, Ruffin MT 4th, Sen A, Brenner DE. Effects of a Mediterranean Diet Intervention on Anti- and Pro-Inflammatory Eicosanoids, Epithelial Proliferation, and Nuclear Morphology in Biopsies of Normal Colon Tissue. Nutr Cancer. 2015;67(5):721-9. doi: 10.1080/01635581.2015.1029637. Epub 2015 Apr 14.

    PMID: 25869112RESULT

  • Li Y, Sen A, Ren J, Askew LM, Sidahmed E, Brenner DE, Ruffin MT 4th, Turgeon DK, Djuric Z. Effects of vitamin E from supplements and diet on colonic alpha- and gamma-tocopherol concentrations in persons at increased colon cancer risk. Nutr Cancer. 2015;67(1):73-81. doi: 10.1080/01635581.2015.965333. Epub 2014 Nov 5.

    PMID: 25372556RESULT

  • Porenta SR, Ko YA, Gruber SB, Mukherjee B, Baylin A, Ren J, Djuric Z. Interaction of fatty acid genotype and diet on changes in colonic fatty acids in a Mediterranean diet intervention study. Cancer Prev Res (Phila). 2013 Nov;6(11):1212-21. doi: 10.1158/1940-6207.CAPR-13-0131. Epub 2013 Sep 10.

    PMID: 24022589RESULT

  • Djuric Z, Bassis CM, Plegue MA, Ren J, Chan R, Sidahmed E, Turgeon DK, Ruffin MT 4th, Kato I, Sen A. Colonic Mucosal Bacteria Are Associated with Inter-Individual Variability in Serum Carotenoid Concentrations. J Acad Nutr Diet. 2018 Apr;118(4):606-616.e3. doi: 10.1016/j.jand.2017.09.013. Epub 2017 Dec 21.

    PMID: 29274690DERIVED

  • Sidahmed E, Sen A, Ren J, Patel A, Turgeon DK, Ruffin MT, Brenner DE, Djuric Z. Colonic Saturated Fatty Acid Concentrations and Expression of COX-1, but not Diet, Predict Prostaglandin E2 in Normal Human Colon Tissue. Nutr Cancer. 2016 Oct;68(7):1192-201. doi: 10.1080/01635581.2016.1213866. Epub 2016 Aug 22.

    PMID: 27548026DERIVED

MeSH Terms

Conditions

Colonic NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Results Point of Contact

Title
Dr. Zora Djuric
Organization
University of Michigan
zoralong@umich.edu
734-615-6210

Study Officials

  • Zora Djuric, Ph.D.

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor

Study Record Dates

First Submitted

May 17, 2007

First Posted

May 21, 2007

Study Start

May 1, 2007

Primary Completion

November 1, 2010

Study Completion

December 1, 2011

Last Updated

September 26, 2016

Results First Posted

July 8, 2015

Record last verified: 2016-08

Locations

US(1)