Tomato Consumption and High Density Lipoprotein-cholesterol

NCT01342666 | Completed Results DMC

• 1 other identifier: REF2039
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoalphalipoproteinemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• High Density Lipoprotein Cholesterol (HDL-c)

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

  Baseline and after one month

Study Arms (2)

Tomato consumption

EXPERIMENTAL

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

Dietary Supplement: Tomato consumption

Cucumber consumption

PLACEBO COMPARATOR

Daily consumption of 300g of cucumber.

Dietary Supplement: Cucumber consumption

Interventions

Tomato consumption DIETARY_SUPPLEMENT

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

Tomato consumption

Cucumber consumption DIETARY_SUPPLEMENT

Daily consumption of 300g of cucumber.

Cucumber consumption

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead
• Instituto Nacional de Cardiologia Ignacio Chavez: collaborator

Study Sites (1)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

México, Tlalpan, 14000, Mexico

Location

Related Publications (10)

• 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.

  PMID: 19148834 BACKGROUND

• 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.

  PMID: 9832077 BACKGROUND

• 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.

  PMID: 10837319 BACKGROUND

• 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.

  PMID: 17144439 BACKGROUND

• 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.

  PMID: 18629373 BACKGROUND

• 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.

  PMID: 16177251 BACKGROUND

• 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.

  PMID: 9168909 BACKGROUND

• 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.

  PMID: 11868053 BACKGROUND

• 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.

  PMID: 9345115 BACKGROUND

• 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.

  PMID: 14647219 BACKGROUND

MeSH Terms

Conditions

Hypoalphalipoproteinemias; Dyslipidemias

Condition Hierarchy (Ancestors)

Hypolipoproteinemias; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Favorable effect of tomato consumption on HDL-c serum levels
• Organization: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMNSZ)

shiverqks@hotmail.com

525555133891

Study Officials

• Francisco J Gomez-Perez, MD, FACE

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 26, 2011
• First Posted: April 27, 2011
• Study Start: March 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 28, 2013
• Results First Posted: February 12, 2013

Record last verified: 2013-02

Locations

ME (1)