Effect of a food supplement (Aquilea Colesterol®) on plasma total cholesterol and LDL cholesterol concentrations

ISRCTN ISRCTN15149502
DOI https://doi.org/10.1186/ISRCTN15149502
Secondary identifying numbers 02/2018
Submission date
07/11/2018
Registration date
20/02/2019
Last edited
04/10/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Ramon Estruch
Scientific

Department of Internal Medicine
Hospital Clinic
Villarroel, 170
Barcelona
08036
Spain

Phone +34 (0)932279365
Email restruch@clinic.cat
Dr Monica Domenech
Scientific

Villarroel 170
Barcelona
08036
Spain

Study information

Study designInterventional single-blinded randomised placebo-controlled parallel group pilot study
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use the contact details to request a participant information sheet
Scientific titleEffect of Aquilea Cholesterol® on plasma cholesterol and lipid profile
Study objectivesThe 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(s)Institutional Review Board of the Hospital Clínic of Barcelona, 07/02/2018, HCB/2017/0994
Health condition(s) or problem(s) studiedHypercholesterolemia
InterventionParticipants 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 typeOther
Primary outcome measure1. 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 measures1. 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 study start date01/09/2017
Completion date20/02/2019

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants45
Total final enrolment40
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/05/2018
Date of final enrolment15/10/2018

Locations

Countries of recruitment

  • Spain

Study participating centre

Hospital Clinic of Barcelona
C/Villarroel 170
Barcelona
08036
Spain

Sponsor information

Uriach Consumer Healthcare S.L.
Industry

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

ROR logo "ROR" https://ror.org/04jfxq686

Funders

Funder type

Industry

Uriach Consumer Healthcare S.L.

No information available

Results and Publications

Intention to publish date01/04/2019
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryStored in repository
Publication and dissemination planIntention to publish in a high-to-medium impact peer-reviewed journal
IPD sharing planThe datasets generated during and/or analysed during the current study will be stored in a non-publically available repository.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 26/04/2019 04/10/2019 Yes No

Editorial Notes

04/10/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
22/10/2019: Internal review.