A Study of Tomato Products and Disease Risk

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2012-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Tomato Extracted Lycopene on Postprandial Oxidation and inﬂammation in Healthy Weight Men and Women

NCT01665469

Postprandial Oxidation and inﬂammation

COMPLETED NA

Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans

NCT01692340

Healthy

COMPLETED PHASE1/PHASE2

Lycopene in Healthy Male Participants

NCT00450957

Healthy, no Evidence of Disease Prostate Cancer

COMPLETED PHASE1

The Cholesterol Lowering Effects of Strawberry

NCT02612090

Hypercholesterolemia Glycemic Response

COMPLETED NA

Maximizing the Anti-inflammatory Effects of Strawberry Bioavailability

NCT01856153

Overweight Healthy

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Inflammation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tomato

Tomato with high carb/fat meal

Group Type ACTIVE_COMPARATOR

Tomato

Intervention Type OTHER

Tomato with high carb/fat meal

Non-Tomato

Non-tomato with high carb/fat meal

Group Type PLACEBO_COMPARATOR

Non-tomato

Intervention Type OTHER

Non-tomato with high carb/fat meal

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tomato

Tomato with high carb/fat meal

Intervention Type OTHER

Non-tomato

Non-tomato with high carb/fat meal

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Active Comparator Placebo Comparator

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes