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Tomato Consumption and High Density Lipoprotein-cholesterol

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ClinicalTrials.gov Identifier: NCT01342666
Recruitment Status : Completed
First Posted : April 27, 2011
Results First Posted : February 12, 2013
Last Update Posted : February 28, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
  • This is a randomized, open-label, single blind, clinical trial
  • The study evaluated the effect of tomato consumption in serum HDL-cholesterol levels.
  • The hypothesis was that two daily tomatoes during one month will increase the HDL-c levels.
  • Since a placebo of tomatoes cannot be done, the control group will receive same proportion of cucumber because 1) it was not possible to have a tomato placebo; 2) cucumber does not have any lycopene; 3) both can be prepared similarly; and 4) the required quantity can be measured in the same way.
  • The intervention was during 1 month and was assigned by randomization.
  • Personnel who did the clinical and biochemical evaluation were blinded for the intervention.
  • Lipid profile was measured before and after the intervention.
  • Confounding factors such as daily physical activity, diet, consumption of fish or alcoholic beverages, smoking status were considered during statistical analyses.

Condition or disease Intervention/treatment
Hypoalphalipoproteinemia Dietary Supplement: Tomato consumption Dietary Supplement: Cucumber consumption

Detailed Description:
Cardiovascular disease (CVD) is a main cause of death worldwide (1) and there are well recognized risk factors associated with its development. Low high density lipoprotein-cholesterol (HDL-c) rank among the most common lipid abnormalities associated with CVD (2). Low HDL-c is currently defined as an HDL-c value below 40 mg/dL for men and below 50 mg/dL for women (3). Factors related with low HDL-c are cigarette smoking (4), high triglycerides (5), sedentary lifestyle (6), and insulin resistance (7). Non-pharmacologic strategies to increase HDL-c concentration are increasing alcohol (8) and fish consumption (9), weight reduction (3), increment in physical activity (10), and smoking cessation (8). Some of these strategies are not applicable or hard to implement in individuals affected with low HDL-c. Moreover, in low-income countries, these interventions could be costly for the general population. Vegetables consumption could be a more affordable and accessible option to treat low HDL-c. Epidemiologic evidence indicates that high consumption of vegetables reduces the risk of cardiovascular disease (11) and particular attention has received tomato-based products. Growing evidence from several epidemiological studies has indicated that lycopene, the major carotenoid in tomato (12), might be more important than other carotenoids in preventing atherosclerosis and CVD (13, 14). The consumption of more than 7 servings per week of tomato-based products has been associated with a 30% reduction in the relative risk of CVD (15). Such potential benefits to vascular health from a tomato-rich diet could be related to low arterial intimal wall thickness (13, 16), reduction of LDL cholesterol levels (17), and inverse correlation with markers of inflammation and vascular endothelial dysfunction (18). However, HDL-c levels could also be positively influenced by tomato consumption. In a pilot study we found that tomato juice consumption did not increase HDL-c after one month (unpublished data), this finding also was recently reported by another group (19). In contrast, other study showed that daily consumption of 300g of uncooked tomatoes, during one month significantly increased HDL-c levels by 15.2% (20). However, this study was not controlled, not blinded, and neither randomized. Roma tomatoes consumption could be an accessible intervention to improve HDL-c levels; however, a longitudinal clinical trial is necessary to evaluate this association. Therefore, we performed a randomized, open-label, single blind, clinical trial to specifically evaluate if consumption of two uncooked tomatoes per day (14 servings/week) during one month could produce a favorable effect on HDL-c.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Tomato Consumption on Serum High Density Lipoprotein-cholesterol Levels. A Randomized, Open-label, Single Blind, Clinical Trial
Study Start Date : March 2009
Primary Completion Date : April 2011
Study Completion Date : December 2011

Arms and Interventions

Arm Intervention/treatment
Experimental: Tomato consumption
Daily consumption of 300g of uncooked roma tomatoes during one month.
Dietary Supplement: Tomato consumption
Daily consumption of 300g of uncooked roma tomatoes during one month.
Placebo Comparator: Cucumber consumption
Daily consumption of 300g of cucumber.
Dietary Supplement: Cucumber consumption
Daily consumption of 300g of cucumber.

Outcome Measures

Primary Outcome Measures :
  1. High Density Lipoprotein Cholesterol (HDL-c) [ Time Frame: Baseline and after one month ]
    To evaluate the effect of two daily tomatoes consumption on HDL-c levels.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Males with HDL-c less than 40 mg/dl
  • Females with HDL-c less than 50 mg/dl
  • Age between 18 to 65 years old
  • Acceptance for participation with signed informed consent

Exclusion Criteria:

Previous diagnosis of:

  • Diabetes,
  • Hypertension,
  • Kidney, liver or heart insufficiency,
  • Hyperuricemia,
  • Hyperandrogenic anovulation,
  • Thyroid dysfunction (hypo or hyperthyroidism),
  • Any difficulty to swallow appropriately, or
  • Hospitalization in the previous six months.

Additionally, those subjects under current treatment with fibrates, statins, nicotinic acid, steroids, allopurinol, hormone replacement therapy (testosterone, estrogens or progesterone), metformin, other oral hypoglycemic agents, insulin, sibutramine, or orlistat treatment and those with daily consumption of any non-steroidal anti-inflammatory drug were also excluded.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01342666

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico, Tlalpan, Mexico, 14000
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Instituto Nacional de Cardiologia Ignacio Chavez
Principal Investigator: Francisco J Gomez-Perez, MD, FACE Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
More Information


Responsible Party: Daniel Cuevas-Ramos, MD, PhD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT01342666     History of Changes
Other Study ID Numbers: REF2039
First Posted: April 27, 2011    Key Record Dates
Results First Posted: February 12, 2013
Last Update Posted: February 28, 2013
Last Verified: February 2013

Keywords provided by Daniel Cuevas-Ramos, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
High density lipoprotein cholesterol

Additional relevant MeSH terms:
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Lipid Metabolism Disorders
Metabolic Diseases