Plain English Summary
Background and study aims
High levels of cholesterol in the blood can cause injury to the arteries, which may lead to a heart attack or stroke. Therefore, it is important to reduce these levels of cholesterol. One strategy for this is to improve lifestyle choices and use food supplements. Certain food supplements, which contain compounds called phytosterols or monacolin (from red rice), are already available on the market and have cholesterol-reducing effects.
This study aims to look at the effectiveness of a new food supplement, Aquilea Colesterol®, containing monacolin, phytosterols and two other cholesterol-reducing compounds (olive hydroxytyrosol and vitamin E) on the levels of cholesterol in the blood.
Who can participate?
Adults aged over 35 years with high cholesterol
What does the study involve?
Participants will be randomly allocated to one of two groups, either the intervention group or the control group. The intervention group will be given the Aquilea Colesterol® supplement, to be taken daily before their main meal for 90 days. The control group will be given a placebo supplement to take daily before their main meal for 90 days. All participants will be asked to attend clinical appointments just before beginning the study, after 4 weeks, and then for a final visit after 12 weeks, where they will be asked to complete a fasted blood test.
What are the potential risks and benefits of the study?
The possible benefit of participating is that individuals in the intervention group may have reduced cholesterol levels. The possible benefits of participating in the study are pain and bruising from the blood test, and potential mild gastrointestinal or muscular symptoms related to taking the food supplement.
Where is the study run from?
Outpatient clinic of the Department of Internal Medicine Service of Hospital Clinic of Barcelona (Spain)
When is the study starting and how long is it expected to run for?
September 2017 to February 2019
Who is funding the study?
Uriach Consumer Healthcare S.L. (Spain)
Who is the main contact?
Dr. Ramon Estruch
restruch@clinic.cat
Trial website
Contact information
Type
Scientific
Primary contact
Dr Ramon Estruch
ORCID ID
Contact details
Department of Internal Medicine
Hospital Clinic
Villarroel
170
Barcelona
08036
Spain
+34 (0)932279365
restruch@clinic.cat
Type
Scientific
Additional contact
Dr Monica Domenech
ORCID ID
Contact details
Villarroel 170
Barcelona
08036
Spain
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
02/2018
Study information
Scientific title
Effect of Aquilea Cholesterol® on plasma cholesterol and lipid profile
Acronym
Study hypothesis
The intake of Aquilea Cholesterol® food supplement (10 mg monacolin K, 1.5 g of phytosterols, 5 mg of olive hydroxytyrosol and 24 mg of vitamin E) is able to significantly reduce the concentration of total cholesterol and LDL cholesterol in patients with hypercholesterolemia.
Ethics approval
Institutional Review Board of the Hospital Clínic of Barcelona, 07/02/2018, HCB/2017/0994
Study design
Interventional single-blinded randomised placebo-controlled parallel group pilot study
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details to request a participant information sheet
Condition
Hypercholesterolemia
Intervention
Participants will be randomly allocated to either the intervention or control group in a 1:1 ratio using a computer-generated random number sequence.
Participants allocated to the intervention group receive 10 mg monacolin K, 1.5 g phytosterols, 5 mg olive hydroxytyrosol and 24 mg vitamin E in a liquid stick (Aquilea Colesterol®). This food supplement should be taken daily for 90 days, preferably before the main meal.
Participants in the control group will receive 1 liquid stick of placebo per day, again to be taken daily for 90 days, preferably before the main meal.
There will be appointments at the baseline, and after 4 and 12 weeks.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Lipid profile change, assessed at the baseline and after 12 weeks:
1.1. Total cholesterol, assessed using enzymatic procedures
1.2. HDL cholesterol, assessed by precipitation with phosphotungistic acid and magnesium chloride using the Advia 2400
1.3. Triglycerides, assessed using enzymatic procedures
1.4. LDL cholesterol, assessed using the following formula: LDL cholesterol = total cholesterol - HDL cholesterol - (triglycerides/5))
2. Change in oxidised LDLs, assessed using ELISA with the mAb-4E6 antibody at the baseline and after 12 weeks
3. Blood pressure, assessed using a validated semiautomatic oscilliometer at the baseline and after 4 and 12 weeks
Secondary outcome measures
1. Change in cardiovascular risk, assessed using the REGICOR score at the baseline and after 12 weeks
2. Change in biomarkers of systemic inflammation, assessed using ELISA at the baseline and after 12 weeks:
2.1. Plasma C-reactive protein (CRP)
2.2. Interleukin-6 (IL-6)
Overall trial start date
01/09/2017
Overall trial end date
20/02/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 35-75 years
2. Low (<5%) or moderate (5-9%) coronary risk according to REGICOR risk tables
3. Total cholesterol values between 200-250 mg/dl according to previous analytical test
4. LDL cholesterol values >115 mg/dl without lipid-lowering treatment
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
45
Total final enrolment
40
Participant exclusion criteria
1. Using or previously used lipid-lowering treatment (statins, fibrates, resins, ezetimibe) and/or any other product with a lipid-lowering effect (red rice, plant sterols) in the previous 3 months
2. Indication for treatment with lipid-lowering drugs
3. Previous cardiovascular disease (myocardial infarction, angina, stroke, peripheral arterial disease)
4. High (10-14%) or very high (≥15%) coronary risk according to REGICOR risk tables
5. BMI ≥30 kg/m²
Recruitment start date
01/05/2018
Recruitment end date
15/10/2018
Locations
Countries of recruitment
Spain
Trial participating centre
Hospital Clinic of Barcelona
C/Villarroel 170
Barcelona
08036
Spain
Funders
Funder type
Industry
Funder name
Uriach Consumer Healthcare S.L.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intention to publish in a high-to-medium impact peer-reviewed journal
IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository.
Intention to publish date
01/04/2019
Participant level data
Stored in repository
Basic results (scientific)
Publication list
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31035469 (added 04/10/2019)