Tomato Consumption and High Density Lipoprotein-cholesterol

This study has been completed.
Sponsor:
Collaborator:
Instituto Nacional de Cardiologia Ignacio Chavez
Information provided by (Responsible Party):
Daniel Cuevas-Ramos, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier:
NCT01342666
First received: April 26, 2011
Last updated: February 23, 2013
Last verified: February 2013
  Purpose
  • 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 Intervention
Hypoalphalipoproteinemia
Dietary Supplement: Tomato consumption
Dietary Supplement: Cucumber consumption

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:

Primary Outcome Measures:
  • High Density Lipoprotein Cholesterol (HDL-c) [ Time Frame: Baseline and after one month ] [ Designated as safety issue: No ]
    To evaluate the effect of two daily tomatoes consumption on HDL-c levels.


Enrollment: 50
Study Start Date: March 2009
Study Completion Date: December 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342666

Locations
Mexico
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
Investigators
Principal Investigator: Francisco J Gomez-Perez, MD, FACE Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  More Information

Publications:

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
Study First Received: April 26, 2011
Results First Received: January 10, 2013
Last Updated: February 23, 2013
Health Authority: Mexico: Ethics Committee

Keywords provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
High density lipoprotein cholesterol
Tomato
Lycopene
Hypoalphalipoproteinemia
Dyslipidemia

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

ClinicalTrials.gov processed this record on April 16, 2014