Cholesterol-lowering activity of a bergamot (Citrus bergamia) extract in Asian and Caucasian subjects: a randomized, double-blind, controlled study

BIONAP srl0 个研究点目标入组 210 人开始时间: 2022年5月5日最近更新: 2023年10月9日

适应症

试验速览

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•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

•1. Subjects <40 and >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

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