NCT01408459

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jan 2007

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2008

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2011

Completed
10.1 years until next milestone

Results Posted

Study results publicly available

September 2, 2021

Completed
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

1.7 years

First QC Date

August 1, 2011

Results QC Date

November 5, 2014

Last Update Submit

May 14, 2025

Conditions

Healthy

Keywords

Prostate cancer prevention

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (4)

  • Diet Adherence to Tomato Product Consumption Between Different Groups

    3 months

  • Consumption of Tomato Products Between Different Groups

    3 months

  • Differences in Dietary Lycopene Intake Between Different Groups

    3 months

  • Plasma Lycopene Concentration Between Different Groups

    3 months

Study Arms (2)

Tomato product

ACTIVE COMPARATOR

Motivational telephone counseling weekly

Dietary Supplement: Tomato Product

Control

PLACEBO COMPARATOR

No Motivation telephone Counseling

Dietary Supplement: Control

Interventions

Tomato ProductDIETARY_SUPPLEMENT

Motivational Telephone Counseling weekly

Also known as: Intervention group
Tomato product
ControlDIETARY_SUPPLEMENT

No Motivational telephone Counseling

Also known as: Control Group
Control

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • prostate cancer diagnosis
  • other cancers \< 5 yrs postdiagnosis except for melanoma
  • already consuming four 1/2 cup servings of tomato products/wk.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60606, United States

Location

Related Publications (1)

  • Park 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: 23200261RESULT

Related Links

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Limitations and Caveats

The number of phone calls and collected diet recalls between groups was different because of concern that the control group would increase their tomato product intake.

Results Point of Contact

Title
Dr. Phyllis E. Bowen
Organization
University of Illinois at Chicago
pbowen@uic.edu
708-524-0586

Study Officials

  • Eunyoung Park, M.S.

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2011

First Posted

August 3, 2011

Study Start

January 4, 2007

Primary Completion

August 30, 2008

Study Completion

September 30, 2008

Last Updated

May 16, 2025

Results First Posted

September 2, 2021

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)