Hypercholesterolemia
Conditions
Brief summary
DESCO is a randomized clinical trial, controlled against placebo, performed to evaluate the effect of a phytosterol-based product (2.5 g/day), after 3 weeks of intake, on the lipid profile, also in relation to the quality of the diet, in subjects with moderate hypercholesterolemia and low / moderate global cardiovascular risk.
Detailed description
This is a randomized, placebo-controlled, double-blind, monocentric cross over clinical study conducted in Italy. The objective of this study is to evaluate the fasting lipid profile of adults with moderate hypercholesterolemia and a low/very low cardiovascular risk, after 3 weeks of supplementation with 2.5 g/day of plant sterols, vs placebo, and to assess the relationship between the effects of the supplementation and the diet.
Interventions
DIETARY_SUPPLEMENTPlant sterols 2.5 g/day
Daily consumption of one stick (2.5 g of plant sterols) during lunch or dinner for 3 weeks
DIETARY_SUPPLEMENTPlacebo
Daily consumption of one stick (the same matrix without plant sterols) during lunch or dinner for 3 weeks
Sponsors
University of Bologna
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Crossover Assignment
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Total cholesterol plasma levels between 200 and 240 mg/dL and/or LDL cholesterol levels between 130 and 160 mg/dL * Triglyceride plasma levels \<200 mg / dL * Cardiovascular risk at 10 years (according to the SCORE algorithm) \<5%. * Signature of the informed consent form
Exclusion criteria
* Subjects in secondary prevention for cardiovascular diseases or with a global cardiovascular risk (according to the SCORE algorithm) \> 5% at 10 years * Triglyceride plasma levels \>200 mg / dL * Decompensated diabetes * Alcoholism * Food allergy * Recent intake of functional foods or supplements for cholesterol control * Intake of lipid-lowering drugs or drugs affecting lipid metabolism in the last 2 months * Alterations in thyroid, hepatic or renal function (transaminases greater than 3 times the maximum values; glomerular filtration rate \<30ml / min), muscle diseases, even if subclinical * Obesity (BMI\> 30) * Any medical or surgical condition that could make the patient's adherence to the study protocol complex or inconstant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting lipid profile | 3 weeks | Evaluation of the effects of the intake of phytosterols on fasting lipid profile, including the following parameters: total and LDL cholesterol, triglycerides, HDL cholesterol, plasma levels of apolipoproteinB-100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | 3 weeks | Evaluation of the effects of the intake of phytosterols on blood pressure |
| Mediterranean index of the diet assessed by validated FFQ | 3 weeks | Assessment of the relationship between the effects of the supplementation with phytosterols and the Mediterranean index of the diet assessed by using a validated food frequency questionnaire (Gnagnarella et al. Nutr Metab Cardiovasc Dis. 2018;28:1140-1147). |
| Weight | 3 weeks | Evaluation of the effects of the intake of phytosterols on weight in kilograms |
| BMI | 3 weeks | Evaluation of the effects of the intake of phytosterols on BMI (weight kilograms and height meters will be combined to report BMI in kg/m\^2 ) |
| Abdominal circumference | 3 weeks | Evaluation of the effects of the intake of phytosterols on abdominal circumference |
Countries
Italy
Outcome results
None listed