Healthy
Conditions
Keywords
Prostate cancer prevention
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.
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.
Interventions
DIETARY_SUPPLEMENTTomato Product
Motivational Telephone Counseling weekly
DIETARY_SUPPLEMENTControl
No Motivational telephone Counseling
Sponsors
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tomato Product Intake Between Different Groups | 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
| Measure | Time frame | Description |
|---|---|---|
| Diet Adherence to Tomato Product Consumption Between Different Groups | 3 months | Using 24-hr recall weekly, consumption of tomato product was measured by serving size. |
| Consumption of Tomato Products Between Different Groups | 3 months | Using 24-hr diet recall, types of tomato products were counted. |
| Differences in Dietary Lycopene Intake Between Different Groups | 3 months | — |
| Plasma Lycopene Concentration Between Different Groups | 3 months | — |
Countries
United States
Participant flow
Recruitment details
Medical Clinic from June 2007 to Aug 2008
Participants by arm
| Arm | Count |
|---|---|
| Tomato Product Tomato Product: Motivational Telephone Counseling weekly | 22 |
| Control No Motivation telephone Counseling
Control: No Motivational telephone Counseling | 15 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Tomato Product | Control | Total |
|---|---|---|---|
| Age, Continuous | 66.2 years STANDARD_DEVIATION 7.2 | 68.4 years STANDARD_DEVIATION 7.44 | 67.1 years STANDARD_DEVIATION 7.3 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 22 Participants | 15 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 15 |
| serious Total, serious adverse events | 0 / 22 | 0 / 15 |
Outcome results
Primary
Tomato Product Intake Between Different Groups
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tomato Product | Tomato Product Intake Between Different Groups | 6.1 servings/week | Standard Deviation 2.1 |
| Control | Tomato Product Intake Between Different Groups | 0.0 servings/week | Standard Deviation 0 |
Secondary
Consumption of Tomato Products Between Different Groups
Using 24-hr diet recall, types of tomato products were counted.
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tomato Product | Consumption of Tomato Products Between Different Groups | 22 participants |
| Control | Consumption of Tomato Products Between Different Groups | 0 participants |
Secondary
Diet Adherence to Tomato Product Consumption Between Different Groups
Using 24-hr recall weekly, consumption of tomato product was measured by serving size.
Time frame: 3 months
Population: Unit: Number of Participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tomato Product | Diet Adherence to Tomato Product Consumption Between Different Groups | 18 Participants |
| Control | Diet Adherence to Tomato Product Consumption Between Different Groups | 5 Participants |
Secondary
Differences in Dietary Lycopene Intake Between Different Groups
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tomato Product | Differences in Dietary Lycopene Intake Between Different Groups | 20.6 mg/day | Standard Deviation 11.3 |
| Control | Differences in Dietary Lycopene Intake Between Different Groups | 7.25 mg/day | Standard Deviation 9.6 |
Secondary
Plasma Lycopene Concentration Between Different Groups
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tomato Product | Plasma Lycopene Concentration Between Different Groups | 0.63 µmol/L | Standard Deviation 0.4 |
| Control | Plasma Lycopene Concentration Between Different Groups | 0.41 µmol/L | Standard Deviation 0.2 |