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

Effect of Aquilea Cholesterol® on plasma cholesterol and lipid profile

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15149502

Enrollment

Registered

2019-02-20

Start date

2018-05-01

Completion date

Unknown

Last updated

2019-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia Nutritional, Metabolic, Endocrine Hypercholesterolaemia

Interventions

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 inte

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 35-75 years 2. Low (115 mg/dl without lipid-lowering treatment

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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)	—

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026