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
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
Scientific
Department of Internal Medicine
Hospital Clinic
Villarroel, 170
Barcelona
08036
Spain
| Phone | +34 (0)932279365 |
|---|---|
| restruch@clinic.cat |
Scientific
Villarroel 170
Barcelona
08036
Spain
Study information
| Study design | Interventional single-blinded randomised placebo-controlled parallel group pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Effect of Aquilea Cholesterol® on plasma cholesterol and lipid profile |
| Study objectives | 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(s) | Institutional Review Board of the Hospital Clínic of Barcelona, 07/02/2018, HCB/2017/0994 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/09/2017 |
| Completion date | 20/02/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 45 |
| Total final enrolment | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2018 |
| Date of final enrolment | 15/10/2018 |
Locations
Countries of recruitment
- Spain
Study participating centre
Barcelona
08036
Spain
Sponsor information
Industry
Palau-Solità i Plegamans 08184 (Barcelona). Avinguda Camí Reial 51-57
Barcelona
08184
Spain
"ROR" |
https://ror.org/04jfxq686 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/04/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Intention to publish in a high-to-medium impact peer-reviewed journal |
| IPD sharing plan | The 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.
