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

NCT06692777 | Completed DMC

• 1 other identifier: CS2-22083
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• The Changes of LDL-C of the Subjects.

  A randomized-double blind trial. The values change of LDL-C between before to after 0, 8, 12, 10 \& 16 weeks.

  16 weeks

Secondary Outcomes (1)

• The changes of Cholesterol of the Subjects.

  16 weeks

Study Arms (2)

Bergavit

EXPERIMENTAL

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

Dietary Supplement: Bergavit

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Bergavit DIETARY_SUPPLEMENT

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

Bergavit

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subjects \<40 and \>70 years old
• Clinical history with relevant presence of any disorder or administration of drugs/food supplement that can potentially interfere with the treatment under study
• lack of compliance defined as not using the correct Bergavit dose or placebo for\>1 week), and inability to give informed consent
• Subjects who have changed their diet significantly or have been placed on weight reduction products
• Smokers, Obesity subjects, during breast feeding
• Changing the eating habits within the 2 weeks previous the screening
• During the pregnancy of the subjects or of the subjective planning of the study
• Subjects with a history of drug, alcohol and other substance abuse
• Known food intolerance or food allergy
• Subjects involved in a clinical or food study within the previous month
• Subjects who have unstable medical diseases (cardiac arrhythmias or ischemia, uncontrolled hypertension and hypotension, diabetes mellitus, kidney failure)
• Subjects with a history of paralysis or cerebral vascular accident
• Subjects with active cancers or on chemotherapy

Sponsors & Collaborators

• Chung Shan Medical University: lead

Study Sites (1)

Chung Shan Medical University

Taichung, Taiwan

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 18, 2024
• Study Start: October 21, 2023
• Primary Completion: September 30, 2024
• Study Completion: October 31, 2024
• Last Updated: November 18, 2024

Record last verified: 2024-09

Locations

TW (1)