Adherence Dynamics for Whole Food Interventions in African-American Men (DAPH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01408459
Recruitment Status : Completed
First Posted : August 3, 2011
Last Update Posted : August 3, 2011
Information provided by:
University of Illinois at Chicago

Brief Summary:
The purposes of this study are to explore the dynamics of adherence, using a simple whole food intervention strategy, both prior to and during the intervention period and to identify nutrient shifts in self-selected diets and to determine health risks (blood pressure, hyperlipidemia, and body weight) that may have resulted from increased tomato product consumption.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Tomato Product Dietary Supplement: Control Not Applicable

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Adherence Dynamics for Whole Food Interventions in African-American Men
Study Start Date : January 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Tomato product Dietary Supplement: Tomato Product
Motivational Telephone Counseling weekly
Other Name: Intervention group
Placebo Comparator: Control
No Motivation telephone Counseling
Dietary Supplement: Control
No Motivational telephone Counseling
Other Name: Control Group

Primary Outcome Measures :
  1. Tomato Product Intake [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. diet adherence [ Time Frame: 3 months ]
  2. behavior change [ Time Frame: 3 months ]
  3. Leukocyte DNA damages [ Time Frame: 3 months ]
  4. Inflammation changes [ Time Frame: 3 months ]
  5. Dietary Lycopene Intake [ Time Frame: 3 months ]
  6. Plasma lycopene concentration [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01408459

United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60606
Sponsors and Collaborators
University of Illinois at Chicago
Principal Investigator: Phyllis E Bowen, Ph.D University of Illinois at Chicago

Responsible Party: Phyllis E. Bowen, Univerisy of Illinois at Chicago Identifier: NCT01408459     History of Changes
Other Study ID Numbers: DAPH2006
First Posted: August 3, 2011    Key Record Dates
Last Update Posted: August 3, 2011
Last Verified: July 2011

Keywords provided by University of Illinois at Chicago:
Prostate cancer prevention