N/A
Completed N=50
Tomato Consumption and High Density Lipoprotein-cholesterol
Hypoalphalipoproteinemia
Source: ClinicalTrials.gov NCT01342666 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcomePrimary: High Density Lipoprotein Cholesterol (HDL-c) — 36.5; 36.8; 41.6; 35.8 mg/dL — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY High Density Lipoprotein Cholesterol (HDL-c) |
36.5; 36.8; 41.6; 35.8 | <0.0001 sig |
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.
Data sourced from ClinicalTrials.gov (NCT01342666). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.