Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000170123
Ethics application status
Approved
Date submitted
23/01/2019
Date registered
5/02/2019
Date last updated
29/06/2021
Date data sharing statement initially provided
5/02/2019
Date results information initially provided
29/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the lipid-lowering effects of the BruMeChol™ dietary supplement in subjects with mild hypercholesterolemia
Scientific title
Evaluation of the lipid-lowering effects of the BruMeChol™ dietary supplement in subjects with mild hypercholesterolemia
Secondary ID [1] 297181 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mild hypercholesterolemia 311220 0
cardiovascular diseases 311221 0
Condition category
Condition code
Cardiovascular 309849 309849 0 0
Other cardiovascular diseases
Alternative and Complementary Medicine 309850 309850 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1 capsule of dietary supplement named BruMeCholTM twice/day for 12 weeks. The capsule of dietary supplement contains a mixture of nutraceutical flavonoid-rich extract of bergamot fruit (100 mg) and polyphenol-rich olive fruit (20 mg) in combination with phytosterols (400 mg) and vitamin K2 (52 mcg). In order to check the compliance, subjects will be asked to bring trial treatment kits (with or without any remaining capsules) with them to each visit.
Intervention code [1] 313440 0
Prevention
Intervention code [2] 313441 0
Treatment: Other
Comparator / control treatment
1 capsule of placebo twice/day for 12 weeks. The white-colored capsule of placebo contains 2% of magnesium stearate, 2% of silicon dioxide and 96% of calcium phosphate. The active treatment (BRuMeChol) is also contained in a white capsule.
Control group
Placebo

Outcomes
Primary outcome [1] 318801 0
change in total cholesterol levels by blood test between experimental arm and placebo comparator arm
Timepoint [1] 318801 0
6 weeks and 12 weeks (primary endpoint) after intervention commencement
Secondary outcome [1] 366084 0
change in HDL cholesterol levels measured by blood tests between experimental arm and placebo comparator arm
Timepoint [1] 366084 0
6 weeks, 12 weeks post-intervention commencement between experimental arm and placebo comparator arm
Secondary outcome [2] 366086 0
change in High-sensitivity C-reactive Protein. (hs-CRP) between experimental arm and placebo comparator arm
Timepoint [2] 366086 0
6 weeks, 12 weeks post-intervention commencement between experimental arm and placebo comparator arm
Secondary outcome [3] 366087 0
change in interleukin-6. (IL-6) by blood test between experimental arm and placebo comparator arm
Timepoint [3] 366087 0
6 weeks, 12 weeks post-intervention commencement between experimental arm and placebo comparator arm
Secondary outcome [4] 366088 0
Change in microRNA-21 by blood test between experimental arm and placebo comparator arm
Timepoint [4] 366088 0
6 weeks, 12 weeks post-intervention commencement between experimental arm and placebo comparator arm
Secondary outcome [5] 366371 0
change in LDL cholesterol levels measured by blood tests between experimental arm and placebo comparator arm
Timepoint [5] 366371 0
6 weeks, 12 weeks post-intervention commencement between experimental arm and placebo comparator arm
Secondary outcome [6] 366372 0
change in Lipoprotein(a), levels measured by blood tests between experimental arm and placebo comparator arm
Timepoint [6] 366372 0
6 weeks, 12 weeks post-intervention commencement between experimental arm and placebo comparator arm
Secondary outcome [7] 366417 0
Change in microRNA-146a by blood test between experimental arm and placebo comparator arm
Timepoint [7] 366417 0
6 weeks, 12 weeks post-intervention commencement between experimental arm and placebo comparator arm

Eligibility
Key inclusion criteria
- blood total cholesterol levels between 200 and 250 mg/dL
- no history of clinically relevant cardiovascular events
- signed informed consent form
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- current therapy with statins or food supplements with lipid-reducing effect
- total cholesterol > 250 or < 200 mg/dl;
- therapy with anticoagulants;
- hypothyroidism, orhyperthyroidism
- insulin-dependent diabetes or diabetes associated with macrovascular complications)
- intestinal malabsorption;
- acute illnesses
- neoplastic disease or < 1-year life expectancy;
- statin non-related liver disease
- severe chronic renal failure
- allergy/intolerance to one or more components of dietary supplement or placebo
- participation in another clinical trial of intervention in the previous three months.
- presence of cognitive disorders and other impediments that do not guarantee the correct adherence to the study treatments;
- current or presumed pregnancy and pregnancy planning;
- incapacity, impossibility or unavailability to sign the written consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/03/2018
Date of last participant enrolment
Anticipated
28/06/2019
Actual
16/01/2020
Date of last data collection
Anticipated
28/09/2019
Actual
20/04/2020
Sample size
Target
125
Accrual to date
Final
125
Recruitment outside Australia
Country [1] 21223 0
Italy
State/province [1] 21223 0
Ancona

Funding & Sponsors
Funding source category [1] 301732 0
Government body
Name [1] 301732 0
Marche Region
Country [1] 301732 0
Italy
Primary sponsor type
Other
Name
IRCCS INRCA
Address
via della Montagnola 81 - I-60127, Ancona, Italy
Country
Italy
Secondary sponsor category [1] 301474 0
None
Name [1] 301474 0
None
Address [1] 301474 0
None
Country [1] 301474 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302457 0
Comitato Etico IRCCS INRCA
Ethics committee address [1] 302457 0
via della Montagnola, n. 81; 60127 Ancona
Ethics committee country [1] 302457 0
Italy
Date submitted for ethics approval [1] 302457 0
28/09/2017
Approval date [1] 302457 0
21/12/2017
Ethics approval number [1] 302457 0
CE INRCA 17018

Summary
Brief summary
This trial aims to evaluate the cholesterol-lowering effect of a nutraceutical flavonoid-rich extract of bergamot fruit and polyphenol-rich olive fruit in combination with phytosterols and vitamin K2, named BruMeCholTM, in the serum of subjects with mild hypercholesterolemia . The study will be conducted as a randomized, double-blind, placebo-controlled, parallel group clinical trial for a period of 12 weeks at the Cardiology Unit of the IRCCS INRCA of Ancona, Italy. A total of 125 subjects (age >40 years) with mild hypercholesterolemia levels (total cholesterol levels between 200 and 250 mg/dl) will be recruited for the study. Participants will take 1 capsule of dietary supplement or placebo two times a day, 15 minutes before the main meal for 12 weeks. Change in serum total cholesterol levels will be evaluated to verify the efficacy of the dietary supplement BrumecholTM in reducing blood total cholestrol levels.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90286 0
Dr Roberto Antonicelli
Address 90286 0
IRCCS INRCA Hospital
Cardiology Unit
via della Montagnola n. 81
60127 Ancona
Country 90286 0
Italy
Phone 90286 0
+ 39 071 800 3450
Fax 90286 0
Email 90286 0
r.antonicelli@inrca.it
Contact person for public queries
Name 90287 0
Dr Roberto Antonicelli
Address 90287 0
Dott. Roberto Antonicelli
IRCCS INRCA Hospital
Cardiology Unit
via della Montagnola n. 81
60127 Ancona
Country 90287 0
Italy
Phone 90287 0
+ 39 071 800 3450
Fax 90287 0
Email 90287 0
r.antonicelli@inrca.it
Contact person for scientific queries
Name 90288 0
Dr Roberto Antonicelli
Address 90288 0
Dott. Roberto Antonicelli
IRCCS INRCA Hospital
Cardiology Unit
via della Montagnola n. 81
60127 Ancona
Country 90288 0
Italy
Phone 90288 0
+ 39 071 800 3450
Fax 90288 0
Email 90288 0
r.antonicelli@inrca.it

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRandomized, Double-Blind, Placebo-Controlled Trial to Test the Effects of a Nutraceutical Combination Monacolin K-Free on the Lipid and Inflammatory Profile of Subjects with Hypercholesterolemia.2022https://dx.doi.org/10.3390/nu14142812
EmbaseThe Association between Single Nucleotide Polymorphisms, including miR-499a Genetic Variants, and Dyslipidemia in Subjects Treated with Pharmacological or Phytochemical Lipid-Lowering Agents.2022https://dx.doi.org/10.3390/ijms23105617
EmbaseEffects of a novel nutraceutical combination (BruMeCholTM) in subjects with mild hypercholesterolemia: Study protocol of a randomized, double-blind, controlled trial.2020https://dx.doi.org/10.1186/s13063-020-04551-4
Dimensions AIMolecular Pathways and Roles for Vitamin K2-7 as a Health-Beneficial Nutraceutical: Challenges and Opportunities2022https://doi.org/10.3389/fphar.2022.896920
N.B. These documents automatically identified may not have been verified by the study sponsor.