NCT00966550

Brief Summary

The purpose of this research study is to test whether certain compounds in tomatoes will help reduce factors in the subject's blood associated with disease risk. The investigators want to know if the tomato-associated compounds will lower or improve the status of these factors, like cholesterol and inflammation. In this research study, the subject will be asked to consume high fat test meals on two separate occasions. The investigators want to see how the subject's body responds to a standard high fat meal, one meal with tomato products and one meal without tomato products. The investigators will measure the subject's blood throughout the study period to determine if consumption of tomato products reduces factors in their blood associated with disease risk.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2009

Typical duration for not_applicable

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

August 1, 2009

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 27, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

October 16, 2014

Completed
Last Updated

March 14, 2017

Status Verified

February 1, 2017

Enrollment Period

2.5 years

First QC Date

August 26, 2009

Results QC Date

August 20, 2014

Last Update Submit

February 3, 2017

Conditions

Inflammation

Keywords

TomatoNutrition

Outcome Measures

Primary Outcomes (1)

  • IL-6 Concentrations

    6 hour postprandial study

Study Arms (2)

Tomato

ACTIVE COMPARATOR

Tomato with high carb/fat meal

Other: Tomato

Non-Tomato

PLACEBO COMPARATOR

Non-tomato with high carb/fat meal

Other: Non-tomato

Interventions

TomatoOTHER

Tomato with high carb/fat meal

Also known as: Active Comparator
Tomato
Non-tomatoOTHER

Non-tomato with high carb/fat meal

Also known as: Placebo Comparator
Non-Tomato

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female
  • Between ages of 18-65
  • BMI between 19 and 24 and hsCRP \< 1mg/L
  • BMI between 25 and 35 and hsCRP \> 2.5mg/L
  • No clinical evidence of cardiovascular, respiratory, renal, GI or hepatic disease

You may not qualify if:

  • Pregnant and/or lactating
  • allergies or intolerances to foods consumed in the study
  • fasting blood glucose \> 110mg/dL
  • taking OTC antioxidant supplements, prescription meds that may interfere with study endpoints
  • unusual dietary habits
  • actively trying to lose or gain weight
  • addicted to drugs or alcohol
  • medically documented psychiatric or neurological disturbances
  • smoker (past smoker allowed if cessation \> 2 years)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

Related Publications (1)

  • Burton-Freeman B, Talbot J, Park E, Krishnankutty S, Edirisinghe I. Protective activity of processed tomato products on postprandial oxidation and inflammation: a clinical trial in healthy weight men and women. Mol Nutr Food Res. 2012 Apr;56(4):622-31. doi: 10.1002/mnfr.201100649. Epub 2012 Feb 14.

    PMID: 22331646RESULT

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

Acute study; Chronic effect should be investigated.

Results Point of Contact

Title
Dr. Britt Burton-Freeman
Organization
Illinois Institute of Technology
bburton@iit.edu
312-567-5307

Study Officials

  • Britt Burton-Freeman, MS, PhD

    Clinical Nutrition Research Center, Illinois Institute of Technology

    PRINCIPAL INVESTIGATOR

  • Indika Edirisinghe, PhD

    Clinical Nutrition Research Center, Illinois Institute of Technology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2009

First Posted

August 27, 2009

Study Start

August 1, 2009

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

March 14, 2017

Results First Posted

October 16, 2014

Record last verified: 2017-02

Locations

US(1)