Know Cancer

or
forgot password

Adherence Dynamics for Whole Food Interventions in African-American Men


N/A
50 Years
N/A
Not Enrolling
Male
Healthy

Thank you

Trial Information

Adherence Dynamics for Whole Food Interventions in African-American Men


African-American (AA) men suffer the greatest proportion of health disparities of any
studied category and adherence to advice among this group has been vastly understudied.

Although there are several ongoing trials for behavioral change, either of diet or
lifestyle, enrollment rates of AA men (< 25%) often provide insufficient numbers to evaluate
adherence issues separately.

Tomatoes, more than lycopene alone, may have beneficial effects on prostate health,
including BPH and prostate cancer. Efficacy trials would require long-term adherence to
high levels of tomato product (TP) consumption.


Inclusion Criteria:



- African-American men aged ≥ 50 yr who recently were found to have serum prostate
specific antigen (PSA) concentrations of >2.5 ng/mL with negative prostate biopsy for
prostate cancer.

- English literacy

- willing to consume tomato products on a regular basis.

Exclusion Criteria:

- prostate cancer diagnosis

- other cancers < 5 yrs postdiagnosis except for melanoma

- already consuming four 1/2 cup servings of tomato products/wk.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Tomato Product Intake

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Phyllis E Bowen, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Illinois

Authority:

United States: Institutional Review Board

Study ID:

DAPH2006

NCT ID:

NCT01408459

Start Date:

January 2007

Completion Date:

September 2008

Related Keywords:

  • Healthy
  • Prostate cancer prevention

Name

Location

University of Illinois at ChicagoChicago, Illinois  60612