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A Study of Tomato Products and Disease Risk (TOM)

This study has been completed.
Sponsor:
Collaborator:
Tomato Wellness Council California
Information provided by (Responsible Party):
Institute for Food Safety and Health, United States
ClinicalTrials.gov Identifier:
NCT00966550
First received: August 26, 2009
Last updated: October 13, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Inflammation
Other: Tomato
Other: Non-tomato

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Tomato Products and Postprandial Oxidation and Inflammation: a Clinical Trial in Healthy Weight Men and Women

Resource links provided by NLM:


Further study details as provided by Institute for Food Safety and Health, United States:

Primary Outcome Measures:
  • IL-6 Concentrations [ Time Frame: 6 hour postprandial study ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: August 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tomato
Tomato with high carb/fat meal
Other: Tomato
Tomato with high carb/fat meal
Other Name: Active Comparator
Placebo Comparator: Non-Tomato
Non-tomato with high carb/fat meal
Other: Non-tomato
Non-tomato with high carb/fat meal
Other Name: Placebo Comparator

Detailed Description:

This study will take three weeks at most, and require one initial screening visit lasting approximately 45 minutes and two study visits each lasting approximately 6 - 8 hours. The investigators are looking for healthy, non-smoking male and female volunteers between the ages of 18 - 65, with no medical history of diabetics, heart, lung, kidney, stomach, or liver disease.

The initial screening visit will determine subject' eligibility through height, weight and waist circumference measurements, blood glucose (finger prick) test and a fasting screening blood draw. There will be no compensation for the screening visit, other than transportation costs.

If subject qualify, subject will continue to the two study visits. Each visit will require subject to have blood drawn several times during subject' study visit (total amount of blood equal to approximately 1 ½ tablespoons). To make this process more tolerable, a registered nurse will place a catheter (similar to what happens when you give blood) into subject's vein for ease in drawing blood. After the catheter placement and the first blood draw, subject will be asked to eat the test meal (tomato or non-tomato meal) and then subject will continue to have blood taken at specific time points for the next 6 hours. The investigators will also do an ultrasound on subject's arm to measure blood flow both before eating and midway through the 6 - hour study visit. The investigators will ask that subject not consume tomatoes or tomato products during the course of the study and record all food and beverages consumed on certain days.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00966550

Locations
United States, Illinois
Clinical Nutrition Research Center
Chicago, Illinois, United States, 60616
Sponsors and Collaborators
Institute for Food Safety and Health, United States
Tomato Wellness Council California
Investigators
Principal Investigator: Britt Burton-Freeman, MS, PhD Institute for Food Safety and Health, United States
Principal Investigator: Indika Edirisinghe, PhD Institute for Food Safety and Health, United States
  More Information

Additional Information:
Publications:
Responsible Party: Institute for Food Safety and Health, United States
ClinicalTrials.gov Identifier: NCT00966550     History of Changes
Other Study ID Numbers: TOM 2009-071
Study First Received: August 26, 2009
Results First Received: August 20, 2014
Last Updated: October 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Institute for Food Safety and Health, United States:
Tomato
Nutrition

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014