Adherence Dynamics for Whole Food Interventions in African-American Men
50 Years
N/A
Male
Healthy
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 Chicago | Chicago, Illinois 60612 |
