Clinical trial · Interventional
Adherence Dynamics for Whole Food Interventions in African-American Men
NCT01408459CI-TRIAL-00089790DAPHcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control | Dietary Supplement | — | UNRESOLVED |
| Tomato Product | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Tomato product
- description
- Motivational telephone counseling weekly
- interventionNames
- Dietary Supplement: Tomato Product
- type
- PLACEBO_COMPARATOR
- label
- Control
- description
- No Motivation telephone Counseling
- interventionNames
- Dietary Supplement: Control
Primary outcomes (1)
- measure
- Tomato Product Intake Between Different Groups
- timeFrame
- 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTPark E, Stacewicz-Sapuntzakis M, Sharifi R, Wu Z, Freeman VL, Bowen PE. Diet adherence dynamics and physiological responses to a tomato product whole-food intervention in African-American men. Br J Nutr. 2013 Jun 28;109(12):2219-30. doi: 10.1017/S0007114512004436. Epub 2012 Nov 19. PMID 23200261