Borderline cholesterol values Nutritional, Metabolic, Endocrine
Conditions
Interventions
The active intervention (Bergavit™) is an extract containing the main flavonoids of Bergamot (Citrus bergamia) juice
while the placebo intervention is maltodextrin. Both the active (150 mg/die of pure flavonoids) and the placebo products are used as follows: one capsule per day intake after lunch or after dinner. Ha
Sponsors
BIONAP srl
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy men and women (40-70 years old) 2.1. Asian subjects with LDL-cholesterol (ranging from 100 to 159; see here below), triglycerides 150-199 mg/dl, BMI 25-29.9 kg/m², glycemia 100-130 mg/dl, fatty liver index (FLI) 30-60 2.2. Caucasian subjects with LDL cholesterol from 160-190 mg/dl, BMI 25-29.9 kg/m², glycemia 100-130 mg/dl, FLI 30-60 3. Subjects naïve to statins or other treatments and food supplements that can interfere with the study treatment for the previous month 4. Reading, understanding and signing approval of the informed consent 5. Non-vegetarian 6. Subjects who will continue, expect reserve, their normal lifestyle 7. Healthy volunteers without clinical illnesses with a relevant effect on the gastrointestinal system or visceral motility 8. Not pregnant 9. Non-smokers 10. Available and willing to follow the procedure of the study protocol
Exclusion criteria
Exclusion criteria: 1. Subjects 70 years old 2. Clinical history with the relevant presence of any disorder or administration of drugs/food supplement that can potentially interfere with the treatment under study 3. Lack of compliance defined as not using the correct Bergavit dose or placebo for>1 week), and inability to give informed consent 4. Subjects who have changed their diet significantly or have been placed on weight reduction products 5. Smokers, obesity 6. Changing the eating habits within the 2 weeks before the screening 7. During the pregnancy of the subjects or of the subjective planning of the study 8. Subject during breastfeeding 9. Subjects with a history of drug, alcohol and other substance abuse 10. The participants who anticipate a change in their lifestyle or physical activity 11. Known food intolerance or food allergy 12. Subjects involved in a clinical or food study within the previous month 13. Subjects who have unstable medical diseases (cardiac arrhythmias or ischemia, uncontrolled hypertension and hypotension, diabetes mellitus, kidney failure) 14. Subjects with a history of paralysis or cerebral vascular accident 14. Subjects with active cancers or on chemotherapy 15. Subjects who have been under diuretics for the previous month 16. Other factors that limit their ability to cooperate during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hypolipidemia (blood concentration of LDL, HDL, total cholesterol, ox-LDL, and triglycerides) measured by a blood test at screening and after 2, 3, and 4 months of intake | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Hypoglycemia (fasting glucose blood concentration) measured by a blood test at screening and after 2, 3, and 4 months of intake 2. Weight measured by a balance at screening and after 2, 3, and 4 months of intake 3. Hepatoprotective activity (blood concentration of AST, ALT, AST/ALT and ?GTP) measured by a blood test at screening and after 2, 3, and 4 months of intake 4. Blood testing to evaluate the following parameters at screening and after 2, 3, and 4 months of intake: HbA1c, HOMA-IR, HOMA-ß, ApoA-I, Apo B, Atherogenic index, Paraoxonase activity, D-Rom test, TNF-a (or C-reactive protein), creatine, insulin 5. Blood pressure measured by a digital sphygmomanometer at screening and after 2, 3, and 4 months of intake | — |
Countries
China, Italy
Outcome results
None listed