Evaluation of the Hypolipidemic Effect of Bergavit by a Human Trial.

NCT ID: NCT06692777

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-21
• Study Completion Date: 2024-10-31

Brief Summary

Bergavit is a product contains bergamot. Bergamot is an endemic plant of the Calabrian region in southern Italy with a unique profile of flavonoids and flavonoid glycosides present in its juice and albedo, its flavonoids was able to reduce serum levels of lipids and ameliorate the thickening of the arteries through modulating enzymatic activities, anti-oxidation, anti-inflammatory mechanisms and inhibition of monocyte activation and proliferation.The primary outcome of the study the assessment of the the hypolipidemic effect of Bergavit. The secondary outcomes are the assessment of: a) the hypoglycemic effect of Bergavit, b) the activity of Bergavit on weight loss, and c) the hepatoprotective activity of Bergavit.

Detailed Description

The study duration is 4 months. Subjects will attend clinic visits as follows:

• T0: First visit: assessment of all baseline parameters, Beginning of treatment
• T2: Second visit: assessment only of LDL level, Total cholesterol, ox-LDL, Triglycerides level, fasting glucose.
• T3: Third visit: assessment of all parameters.
• T4: Fourth visit: assessment of all parameters, end of the treatment.

Conditions

Hyperlipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Bergavit

Group Bergavit : 60 subjects treated with Bergavit capsule intake of 150 mg/die of pure flavonoids for 4 months.

Group Type: EXPERIMENTAL

Bergavit

Intervention Type: DIETARY_SUPPLEMENT

Subjects treated with Bergavit capsule intake of 150 mg/die of pure flavonoids for 4 months.

Placebo

Group Placebo: 60 subjects will take capsule equivalent amount of maltodextrin for 4 months.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Subjects will take capsule equivalent amount of maltodextrin for 4 months.

Interventions

Bergavit

Subjects treated with Bergavit capsule intake of 150 mg/die of pure flavonoids for 4 months.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Subjects will take capsule equivalent amount of maltodextrin for 4 months.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 1 Healthy men and women (40-70 years old);
• 2 Asian subjects with LDL-cholesterol (ranging from 100 to 159; see here below)
• 3 Subjects naïve to statins or other treatment and food supplement that can interfere with the study treatment for the previous 1 month
• 4 Reading, understanding and signed approval of the informative consent
• 5 No vegetarian. Subjects who will continue, expect reserve, their normal lifestyle
• 6 Healthy volunteers without clinical illness diagnosed with relevant effect on the gastrointestinal system or the motility visceral

Exclusion Criteria

• 1 Subjects <40 and >70 years old
• 2 Clinical history with 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 subjects, during breast feeding
• 6 Changing the eating habits within the 2 weeks previous the screening
• 7 During the pregnancy of the subjects or of the subjective planning of the study
• 8 Subjects with a history of drug, alcohol and other substance abuse
• 9 Known food intolerance or food allergy
• 10 Subjects involved in a clinical or food study within the previous month
• 11 Subjects who have unstable medical diseases (cardiac arrhythmias or ischemia, uncontrolled hypertension and hypotension, diabetes mellitus, kidney failure)
• 12 Subjects with a history of paralysis or cerebral vascular accident
• 13 Subjects with active cancers or on chemotherapy

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chung Shan Medical University

OTHER

Sponsor Role: lead

Responsible Party

You-Cheng Shen

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chung Shan Medical University

Taichung, , Taiwan

Countries

Taiwan

Other Identifiers

CS2-22083

Identifier Type: -

Identifier Source: org_study_id