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Completed

NCT Number: NCT01342666

Tomato Consumption and High Density Lipoprotein-cholesterol

* 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

México, Tlalpan, 14000, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Tomato consumption

Dietary Supplement

Daily consumption of 300g of uncooked roma tomatoes during one month.

Cucumber consumption

Dietary Supplement

Daily consumption of 300g of cucumber.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Other

Collaborators

  • Instituto Nacional de Cardiologia Ignacio Chavez

Registry information

Official study title

Effect of Tomato Consumption on Serum High Density Lipoprotein-cholesterol Levels. A Randomized, Open-label, Single Blind, Clinical Trial

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 27, 2011
Registry last updated
Feb 28, 2013

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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