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Tomato Consumption and High Density Lipoprotein-cholesterol

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01342666
Enrollment
50
Registered
2011-04-27
Start date
2009-03-31
Completion date
2011-12-31
Last updated
2013-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoalphalipoproteinemia

Keywords

High density lipoprotein cholesterol, Tomato, Lycopene, Hypoalphalipoproteinemia, Dyslipidemia

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.

Interventions

DIETARY_SUPPLEMENTTomato consumption

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

DIETARY_SUPPLEMENTCucumber consumption

Daily consumption of 300g of cucumber.

Sponsors

Instituto Nacional de Cardiologia Ignacio Chavez
CollaboratorOTHER
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
High Density Lipoprotein Cholesterol (HDL-c)Baseline and after one monthTo evaluate the effect of two daily tomatoes consumption on HDL-c levels.

Countries

Mexico

Participant flow

Recruitment details

From 1st of March of 2009 to 30 of April of 2011 we invited workers and patients from the INCMNSZ to participate in the study. Interested subjects were selected in a consecutive basis.

Pre-assignment details

We performed clinical, nutritional, anthropometric, and biochemical evaluations. The protocol included a two-week run-in period with prescription of an isocaloric diet. Participants were instructed to minimize changes in diet, daily activities, specifically physical activity and smoking.

Participants by arm

ArmCount
Tomato Consumption
Participants were randomized to receive 300 g of uncooked tomato (2 daily roma tomatoes approximately).
26
Cucumber Consumption
Participants were randomized to receive 300 g of cucumber (control group).
24
Total50

Baseline characteristics

CharacteristicCucumber ConsumptionTomato ConsumptionTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
24 Participants26 Participants50 Participants
Age Continuous40.3 years
STANDARD_DEVIATION 16
43.4 years
STANDARD_DEVIATION 15.5
41.8 years
STANDARD_DEVIATION 15.7
Region of Enrollment
Mexico
24 participants26 participants50 participants
Sex: Female, Male
Female
19 Participants22 Participants41 Participants
Sex: Female, Male
Male
5 Participants4 Participants9 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 260 / 24
serious
Total, serious adverse events
0 / 260 / 24

Outcome results

Primary

High Density Lipoprotein Cholesterol (HDL-c)

To evaluate the effect of two daily tomatoes consumption on HDL-c levels.

Time frame: Baseline and after one month

Population: The sample size was calculated using the formula for means for two-tailed comparisons. According to a previous report, we expected a minimal change of 5 mg/dL in HDL-c after one month of consumption. Using a SD of 9 mg/dL with alfa of 0.05 and study power of 80%, a total of 48 subjects were calculated.

ArmMeasureGroupValue (MEAN)Dispersion
Tomato ConsumptionHigh Density Lipoprotein Cholesterol (HDL-c)Baseline HDL-c36.5 mg/dLStandard Deviation 7.5
Tomato ConsumptionHigh Density Lipoprotein Cholesterol (HDL-c)Final HDL-c41.6 mg/dLStandard Deviation 6.9
Cucumber ConsumptionHigh Density Lipoprotein Cholesterol (HDL-c)Baseline HDL-c36.8 mg/dLStandard Deviation 7.2
Cucumber ConsumptionHigh Density Lipoprotein Cholesterol (HDL-c)Final HDL-c35.8 mg/dLStandard Deviation 7.3
Comparison: We test the effect of two daily roma tomatoes during one month in HDL-c levels. We estimate the sample size to have a 80% study power.p-value: <0.000195% CI: [3.2925, 6.9383]t-test, 2 sided
p-value: <0.000195% CI: [4.027, 7.232]Regression, Linear

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026