A Study of Tomato Products and Disease Risk

Inflammation Clinical Trial

— TOM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00966550
• Other study ID #: TOM 2009-071
• Status: Completed
• Phase: N/A
• First received: August 26, 2009
• Last updated: May 18, 2016
• Start date: August 2009
• Est. completion date: February 2012

Study information

• Verified date: May 2016
• Source: Institute for Food Safety and Health, United States
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Inflammation

Intervention

Other:
• Tomato
Tomato with high carb/fat meal
• Non-tomato
Non-tomato with high carb/fat meal

Locations

Country	Name	City	State
United States	Clinical Nutrition Research Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Institute for Food Safety and Health, United States	Tomato Wellness Council California

Country where clinical trial is conducted

United States, 

References & 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. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IL-6 Concentrations		6 hour postprandial study	No

External Links

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