Subclinical atherosclerosis in a healthy population Circulatory System Atherosclerosis
Conditions
Interventions
Clinical study of FruitexB-X® mg versus placebo.
Study duration: 30 days, two doses per day.
Four time points: day 1, 4, 7, and 30
Placebo-controlled, d
Sponsors
Natural Research Ltd (Romania)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 40-60 2. Gender ratio: 50% females and 50% males 3. BMI range: 24-27 (overweight but not obese) 4. Normal or minor hypertension (3 mg/l) 6. Increased LDL (>130) 7. Increased triglyceride level (>200) 8. Reduced HDL level (<40) 9. Fasted glucose level (<100) 10. Informed consent obtained at selection
Exclusion criteria
Exclusion criteria: Subjects with nonphysiological and pathological conditions such as: 1. Cardiovascular (CV) symptoms (e.g., angina, shortness of breath, etc) 2. CV disease 3. Diabetes mellitus or renal failure 4. Infectious or inflammatory disease 5. Active allergy 6. Smokers 7. Subjects who consume more than two alcoholic beverages per day 8. Subjects using any supplements 30 days prior to the initiation of the study 9. Subjects using statins, anti-hypertensive, anti-hyperlipidemia, anti-inflammatory, or anti-diabetic medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood clinical laboratory tests: 1. Fasting plasma glucose 2. Total, LDL and HDL cholesterol, triglycerides 3. High-sensitivity C-reactive protein (hs-CRP) 4. Metallic metalloproteinase-9 (MMP-9) 5. Monocyte chemotactic protein 1 (MCP-1) 6. Lipoprotein-associated phospholipase A(2) (Lp-PLA(2)) 7. IL-6 8. Homocysteine 9. oxLDL 10. Vitamin D3 (Calcidiol) 11. Adiponectin 12. Insulin 13. PON-1 14. Isoprostanes | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical exam 2. 12-lead ECG 3. Ankle-brachial index | — |
Countries
Romania
Outcome results
None listed