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Tomato Consumption and High Density Lipoprotein-cholesterol

Primary Purpose

Hypoalphalipoproteinemia

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Tomato consumption
Cucumber consumption
Sponsored by
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoalphalipoproteinemia focused on measuring High density lipoprotein cholesterol, Tomato, Lycopene, Hypoalphalipoproteinemia, Dyslipidemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tomato consumption

Cucumber consumption

Arm Description

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

Daily consumption of 300g of cucumber.

Outcomes

Primary Outcome Measures

High Density Lipoprotein Cholesterol (HDL-c)
To evaluate the effect of two daily tomatoes consumption on HDL-c levels.

Secondary Outcome Measures

Full Information

First Posted
April 26, 2011
Last Updated
February 23, 2013
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborators
Instituto Nacional de Cardiologia Ignacio Chavez
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1. Study Identification

Unique Protocol Identification Number
NCT01342666
Brief Title
Tomato Consumption and High Density Lipoprotein-cholesterol
Official Title
Effect of Tomato Consumption on Serum High Density Lipoprotein-cholesterol Levels. A Randomized, Open-label, Single Blind, Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborators
Instituto Nacional de Cardiologia Ignacio Chavez

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoalphalipoproteinemia
Keywords
High density lipoprotein cholesterol, Tomato, Lycopene, Hypoalphalipoproteinemia, Dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tomato consumption
Arm Type
Experimental
Arm Description
Daily consumption of 300g of uncooked roma tomatoes during one month.
Arm Title
Cucumber consumption
Arm Type
Placebo Comparator
Arm Description
Daily consumption of 300g of cucumber.
Intervention Type
Dietary Supplement
Intervention Name(s)
Tomato consumption
Intervention Description
Daily consumption of 300g of uncooked roma tomatoes during one month.
Intervention Type
Dietary Supplement
Intervention Name(s)
Cucumber consumption
Intervention Description
Daily consumption of 300g of cucumber.
Primary Outcome Measure Information:
Title
High Density Lipoprotein Cholesterol (HDL-c)
Description
To evaluate the effect of two daily tomatoes consumption on HDL-c levels.
Time Frame
Baseline and after one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco J Gomez-Perez, MD, FACE
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
City
Mexico
State/Province
Tlalpan
ZIP/Postal Code
14000
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
19148834
Citation
Ali MM, Agha FG. Amelioration of streptozotocin-induced diabetes mellitus, oxidative stress and dyslipidemia in rats by tomato extract lycopene. Scand J Clin Lab Invest. 2009;69(3):371-9. doi: 10.1080/00365510802658473.
Results Reference
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PubMed Identifier
9832077
Citation
Agarwal S, Rao AV. Tomato lycopene and low density lipoprotein oxidation: a human dietary intervention study. Lipids. 1998 Oct;33(10):981-4. doi: 10.1007/s11745-998-0295-6.
Results Reference
background
PubMed Identifier
10837319
Citation
Arab L, Steck S. Lycopene and cardiovascular disease. Am J Clin Nutr. 2000 Jun;71(6 Suppl):1691S-5S; discussion 1696S-7S. doi: 10.1093/ajcn/71.6.1691S.
Results Reference
background
PubMed Identifier
17144439
Citation
Blum A, Merei M, Karem A, Blum N, Ben-Arzi S, Wirsansky I, Khazim K. Effects of tomatoes on the lipid profile. Clin Invest Med. 2006 Oct;29(5):298-300.
Results Reference
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PubMed Identifier
18629373
Citation
Denniss SG, Haffner TD, Kroetsch JT, Davidson SR, Rush JW, Hughson RL. Effect of short-term lycopene supplementation and postprandial dyslipidemia on plasma antioxidants and biomarkers of endothelial health in young, healthy individuals. Vasc Health Risk Manag. 2008;4(1):213-22. doi: 10.2147/vhrm.2008.04.01.213.
Results Reference
background
PubMed Identifier
16177251
Citation
Ashen MD, Blumenthal RS. Clinical practice. Low HDL cholesterol levels. N Engl J Med. 2005 Sep 22;353(12):1252-60. doi: 10.1056/NEJMcp044370. No abstract available. Erratum In: N Engl J Med. 2006 Jan 12;354(2):215.
Results Reference
background
PubMed Identifier
9168909
Citation
Fuhrman B, Elis A, Aviram M. Hypocholesterolemic effect of lycopene and beta-carotene is related to suppression of cholesterol synthesis and augmentation of LDL receptor activity in macrophages. Biochem Biophys Res Commun. 1997 Apr 28;233(3):658-62. doi: 10.1006/bbrc.1997.6520.
Results Reference
background
PubMed Identifier
11868053
Citation
Gianetti J, Pedrinelli R, Petrucci R, Lazzerini G, De Caterina M, Bellomo G, De Caterina R. Inverse association between carotid intima-media thickness and the antioxidant lycopene in atherosclerosis. Am Heart J. 2002 Mar;143(3):467-74. doi: 10.1067/mhj.2002.120776.
Results Reference
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PubMed Identifier
9345115
Citation
Kohlmeier L, Kark JD, Gomez-Gracia E, Martin BC, Steck SE, Kardinaal AF, Ringstad J, Thamm M, Masaev V, Riemersma R, Martin-Moreno JM, Huttunen JK, Kok FJ. Lycopene and myocardial infarction risk in the EURAMIC Study. Am J Epidemiol. 1997 Oct 15;146(8):618-26. doi: 10.1093/oxfordjournals.aje.a009327.
Results Reference
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PubMed Identifier
14647219
Citation
Re R, Mishra GD, Thane CW, Bates CJ. Tomato consumption and plasma lycopene concentration in people aged 65 y and over in a British national survey. Eur J Clin Nutr. 2003 Dec;57(12):1545-54. doi: 10.1038/sj.ejcn.1601723.
Results Reference
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Tomato Consumption and High Density Lipoprotein-cholesterol

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