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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 17 October 2012
Main ID:  NCT01342666
Date of registration: 26/04/2011
Primary sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Public title: Effect of Lycopene on HDL-cholesterol Level
Scientific title: Effect of Lycopene in HDL-cholesterol. A Randomized, Double-blind Clinical Trial
Date of first enrolment: October 2010
Target sample size: 50
Recruitment status: Recruiting
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment  
Countries of recruitment
Key inclusion & exclusion 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 60 years old

- Acceptance for participation with signed informed consent

Exclusion Criteria:

- High triglycerides level (more than 150 mg/dl)

- Use of fibrates or statins

- Use of other treatments to reduce cholesterol

- Administration of drugs related with change in insulin sensitivity such as metformin,
glitazones among others.

- Pregnancy or lactation

- Abnormal kidney or liver function

- Acute illness or hospitalization in last six months

- Unable to eat per mouth

- Unable to understand the indications given by nutritionist

- Unable to assist to follow-up visits

Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Dietary Supplement: Cucumber consumption
Dietary Supplement: Lycopene
Primary Outcome(s)
HDL-c level [Time Frame: 1 month]
Secondary Outcome(s)
Serum activity of CTEP and LCAT enzymes [Time Frame: 1 month]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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