Trial Outcomes & Findings for Tomato Consumption and High Density Lipoprotein-cholesterol (NCT NCT01342666)

NCT ID: NCT01342666

Last Updated: 2013-02-28

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: Baseline and after one month
• Results posted on: 2013-02-28

Participant Flow

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.

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.

Participant milestones

Measure	Tomato Consumption Participants were randomized to receive 300 g of uncooked tomato (2 daily roma tomatoes approximately).	Cucumber Consumption Participants were randomized to receive 300 g of cucumber (control group).
Overall Study STARTED	26	24
Overall Study COMPLETED	26	24
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tomato Consumption and High Density Lipoprotein-cholesterol

Baseline characteristics by cohort

Measure	Tomato Consumption n=26 Participants Participants were randomized to receive 300 g of uncooked tomato (2 daily roma tomatoes approximately).	Cucumber Consumption n=24 Participants Participants were randomized to receive 300 g of cucumber (control group).	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants	24 Participants n=7 Participants	50 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	43.4 years STANDARD_DEVIATION 15.5 • n=5 Participants	40.3 years STANDARD_DEVIATION 16.0 • n=7 Participants	41.8 years STANDARD_DEVIATION 15.7 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	19 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment Mexico	26 participants n=5 Participants	24 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Tomato Consumption n=26 Participants Participants were randomized to receive 300 g of uncooked tomato (2 daily roma tomatoes approximately).	Cucumber Consumption n=24 Participants Participants were randomized to receive 300 g of cucumber (control group).
High Density Lipoprotein Cholesterol (HDL-c) Baseline HDL-c	36.5 mg/dL Standard Deviation 7.5	36.8 mg/dL Standard Deviation 7.2
High Density Lipoprotein Cholesterol (HDL-c) Final HDL-c	41.6 mg/dL Standard Deviation 6.9	35.8 mg/dL Standard Deviation 7.3

Adverse Events

Tomato Consumption

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cucumber Consumption

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Favorable effect of tomato consumption on HDL-c serum levels

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMNSZ)

Phone: 525555133891

Email: shiverqks@hotmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place