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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plant sterol supplementation | Experimental | 2.5 g of phytosterols in pre-dosed sticks (oral supplementation) |
|
| Placebo | Placebo Comparator | Placebo in pre-dosed sticks (the same matrix without plant sterols) (oral supplementation) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plant sterols 2.5 g/day | Dietary Supplement | Daily consumption of one stick (2.5 g of plant sterols) during lunch or dinner for 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fasting lipid profile | 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. | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mediterranean index of the diet assessed by validated FFQ | 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). | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| S. Orsola-Malpighi University Hospital | Bologna | 40038 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37960208 | Result | Cicero AFG, Fogacci F, Giovannini M, Rizzoli E, Grandi E, D'Addato S, Borghi C. The Effect of Dietary Supplementation with Plant Sterols on Total and LDL-Cholesterol in Plasma Is Affected by Adherence to Mediterranean Diet: Insights from the DESCO Randomized Clinical Study. Nutrients. 2023 Oct 27;15(21):4555. doi: 10.3390/nu15214555. |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D010840 | Phytosterols |
| ID | Term |
|---|---|
| D013261 | Sterols |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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Crossover Assignment
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| Placebo | Dietary Supplement | Daily consumption of one stick (the same matrix without plant sterols) during lunch or dinner for 3 weeks |
|
| Weight |
Evaluation of the effects of the intake of phytosterols on weight in kilograms |
| 3 weeks |
| BMI | 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 ) | 3 weeks |
| Abdominal circumference | Evaluation of the effects of the intake of phytosterols on abdominal circumference | 3 weeks |
| Blood pressure | Evaluation of the effects of the intake of phytosterols on blood pressure | 3 weeks |
| D009750 |
| Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D064209 | Phytochemicals |
| D001685 | Biological Factors |