Diet and Plant Sterols in the Control of Cholesterolemia (DESCO)
- Conditions
- Hypercholesterolemia
- Interventions
- Dietary Supplement: Plant sterols 2.5 g/dayDietary Supplement: Placebo
- Registration Number
- NCT05265455
- Lead Sponsor
- University of Bologna
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Plant sterol supplementation Plant sterols 2.5 g/day 2.5 g of phytosterols in pre-dosed sticks (oral supplementation) Placebo Placebo Placebo in pre-dosed sticks (the same matrix without plant sterols) (oral supplementation)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 )
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).
Abdominal circumference 3 weeks Evaluation of the effects of the intake of phytosterols on abdominal circumference
Trial Locations
- Locations (1)
S. Orsola-Malpighi University Hospital
🇮🇹Bologna, Italy