Subjects with mildly altered cholesterol levels Other
Conditions
Interventions
Here is the revised text for clarity:
The subjects recruited for this clinical study were randomly assigned to one of the following groups:
1. Group 1 (38 subjects): Subjects took one tablet of the
Sponsors
GRICAR Chemical S.r.l.
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Were aged between 18 and 70 years 2. Were able to understand and sign the informed consent 3. Had a negative HIV test 4. Had a negative pregnancy test 5. Had borderline total cholesterol values, between 200 and 239 mg/dL 6. Had LDL cholesterol values < 159 mg/dL 7. Were not taking and did not take any type of medication throughout the study period
Exclusion criteria
Exclusion criteria: 1. Age 70 years 2. Subjects at high risk for cardiovascular events based on 8 risk factors (sex, age, diabetes, smoking habits, systolic blood pressure, total cholesterol, HDL cholesterol, and antihypertensive treatment) according to the parameters of the Cuore Project of the Istituto Superiore di Sanità 3. On pharmacological therapy for cholesterol, including low doses 4. Use of supplements for cholesterol control, glycemia, and metabolic syndrome in the two weeks preceding recruitment 5. Pregnant women, suspected pregnancy, or planned pregnancy 6. Women in lactation 7. Blood donors in the three months preceding recruitment 8. Non-self-sufficient individuals 9. Individuals unwilling to collaborate 10. Individuals unable to attend the reference facility within the required time frame 11. Subjects deemed unsuitable by the principal investigator due to other conditions considered incompatible with enrollment and requiring pharmacological treatments 12. Subjects with acquired immunodeficiency due to HIV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. LDL cholesterol concentration is measured using a blood test at run-in, baseline (t0), and 90 days (t2) of treatment 2. Total plasma cholesterol concentration is measured using a blood test at run-in, baseline (t0), and 90 days (t2) of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total cholesterol (TC) is measured using a blood test at run-in (tr), baseline (t0), and 90 days (t2) of treatment 2. HDL cholesterol is measured using a blood test at baseline (t0) and 90 days (t2) of treatment 3. Triglycerides (TG) are measured using a blood test at baseline (t0) and 90 days (t2) of treatment 4. Glycated hemoglobin is measured using a blood test at baseline (t0) and 90 days (t2) of treatment 5. Blood glucose is measured using a blood test at baseline (t0) and 90 days (t2) of treatment 6. Body weight is measured using BMI (kg/m²) and abdominal circumference at baseline (t0) and 90 days (t2) of treatment 7. White blood cells are measured using a blood test at baseline (t0) and 90 days (t2) of treatment 8. Erythrocyte sedimentation rate (ESR) is measured using a blood test at baseline (t0) and 90 days (t2) of treatment 9. C-reactive protein (CRP) is measured using a blood test at baseline (t0) and 90 days (t2) of treatment 10. Serum Glutamic Oxaloacetic Transaminase (SGOT) is measured using a blood test at baseline (t0), 30 days (t1), and 90 days (t2) of treatment 11. Serum Glutamate Pyruvate Transaminase (SGPT) is measured using a blood test at baseline (t0), 30 days (t1), and 90 days (t2) of treatment 12. Creatinine is measured using a blood test at baseline (t0), 30 days (t1), and 90 days (t2) of treatment | — |
Countries
Italy
Contacts
Public ContactAlessandra Baldi
Outcome results
None listed