N/A
Completed N=37
Adherence Dynamics for Whole Food Interventions in African-American Men
Healthy
Source: ClinicalTrials.gov NCT01408459 ↗
Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcomePrimary: Tomato Product Intake Between Different Groups — 6.1; 0.0 servings/week
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tomato Product Intake Between Different Groups |
6.1; 0.0 | — |
| SECONDARY Diet Adherence to Tomato Product Consumption Between Different Groups |
18; 5 | — |
| SECONDARY Consumption of Tomato Products Between Different Groups |
22; 0 | — |
| SECONDARY Differences in Dietary Lycopene Intake Between Different Groups |
20.6; 7.25 | — |
| SECONDARY Plasma Lycopene Concentration Between Different Groups |
0.63; 0.41 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01408459). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.