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Clinical Trials/NCT01342666
NCT01342666CompletedNot Applicable

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

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran2 sites in 1 country50 target enrollmentStarted: March 1, 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
50
Locations
2
Primary Endpoint
High Density Lipoprotein Cholesterol (HDL-c)

Study Overview

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.

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
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
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.

Arms & Interventions

Tomato consumption

Experimental

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

Intervention: Tomato consumption (Dietary Supplement)

Cucumber consumption

Placebo Comparator

Daily consumption of 300g of cucumber.

Intervention: Cucumber consumption (Dietary Supplement)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Daniel Cuevas-Ramos

MD, PhD

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study Sites (2)

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