Condition category
Nutritional, Metabolic, Endocrine
Date applied
07/11/2018
Date assigned
20/02/2019
Last edited
22/02/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

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

Sponsor information

Organisation

Uriach Consumer Healthcare S.L.

Sponsor details

Palau-Solità i Plegamans 08184 (Barcelona). Avinguda Camí Reial 51-57
Barcelona
08184
Spain

Sponsor type

Industry

Website

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

Publication citations

Additional files

Editorial Notes

22/10/2019: Internal review.