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| Name | Class |
|---|---|
| Meda Pharma S.p.A. | UNKNOWN |
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This randomized, double-blind, placebo-controlled, parallel-group clinical study aims to evaluate the effect of a dietary supplement on LDL-cholesterol levels in healthy adults with suboptimal LDL-C values. Eligible participants will follow standard dietary recommendations based on the Mediterranean diet, according to the European Atherosclerosis Society guidelines. Subjects will be randomized to receive either the dietary supplement (1 tablet/day) or placebo (1 tablet/day), both in combination with dietary recommendations, over a treatment period of 12 weeks.
The primary objective is to compare the effect of the tested food supplement versus placebo on LDL-cholesterol after 12 weeks of treatment. Secondary objectives include evaluating changes in LDL-cholesterol at 6 weeks, other lipid fractions, homocysteine, glucose and insulin levels, hsCRP, anthropometric parameters, as well as tolerability and acceptability of the supplement. Safety will be assessed through the collection of adverse events.
Study participation lasts approximately 16 weeks, including screening, diet stabilization run-in, treatment, and follow-up assessments. Outcome measures will be collected at baseline, after 6 weeks, and after 12 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novel food supplement and mediterranean diet | Experimental |
| |
| Placebo and mediterranean diet | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NUT2 | Dietary Supplement | Food supplement formulated with natural extracts |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect on LDL Cholesterol | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effect on LDL Cholesterol | 6 weeks | |
| Effect on Total Cholesterol | 12 weeks | |
| Effect on Total Cholesterol |
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Inclusion Criteria:
The subjects will have to meet all the following inclusion criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colledoro Medical Center | Siena | Siena | 53100 | Italy |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Other | Placebo |
|
| 6 weeks |
| Effect on HDL Cholesterol | 12 weeks |
| Effect on HDL Cholesterol | 6 weeks |
| Effect on Tryglicerides | 12 weeks |
| Effect on Tryglicerides | 6 weeks |
| Effect on Homocysteine | 12 weeks |
| Effect on Homocysteine | 6 weeks |
| Effect on Glycaemia | 12 weeks |
| Effect on Glycaemia | 6 weeks |
| Effect on Insulin | 12 weeks |
| Effect on Insulin | 6 weeks |
| Effect on Body Weight | 12 weeks |
| Effect on Body Weight | 6 weeks |
| Effect on Waist Circumference | 12 weeks |
| Effect on Waist Circumference | 6 weeks |
| Effect on Blood Pressure | 12 weeks |
| Effect on Blood Pressure | 6 weeks |
| Effect on hsCRP | 12 weeks |
| Effect on hsCRP | 6 weeks |