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Completed

NCT Number: NCT00966550

A Study of Tomato Products and Disease Risk

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tomato

Other

Tomato with high carb/fat meal

Other names: Active Comparator

Non-tomato

Other

Non-tomato with high carb/fat meal

Other names: Placebo Comparator

Primary outcomes

  1. IL-6 Concentrations

    Time frame: 6 hour postprandial study

Sponsors and collaborators

Lead sponsor

Clinical Nutrition Research Center, Illinois Institute of Technology

Industry

Collaborators

  • Tomato Products Wellness Council

Registry information

Official study title

Tomato Products and Postprandial Oxidation and Inflammation: a Clinical Trial in Healthy Weight Men and Women

Acronym: TOM

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 27, 2009
Registry last updated
Mar 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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