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OpenTrials
Completed

NCT Number: NCT01408459

Adherence Dynamics for Whole Food Interventions in African-American Men

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.

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Key information

Conditions

Healthy

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois at Chicago

Chicago, Illinois, 60606, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tomato Product

Dietary Supplement

Motivational Telephone Counseling weekly

Other names: Intervention group

Control

Dietary Supplement

No Motivational telephone Counseling

Other names: Control Group

Primary outcomes

  1. Tomato Product Intake Between Different Groups

    Time frame: 3 months

    The intervention group: aimed to achieve the goal of more than five servings of TP/week while control group aimed to eat vegetable instead of tomatoes.

Secondary outcomes

  1. Diet Adherence to Tomato Product Consumption Between Different Groups

    Time frame: 3 months

    Using 24-hr recall weekly, consumption of tomato product was measured by serving size.

  2. Consumption of Tomato Products Between Different Groups

    Time frame: 3 months

    Using 24-hr diet recall, types of tomato products were counted.

  3. Differences in Dietary Lycopene Intake Between Different Groups

    Time frame: 3 months

  4. Plasma Lycopene Concentration Between Different Groups

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Acronym: DAPH

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 3, 2011
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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