Clinical trial NCT06333158: Extracts of Amla, Walnut Leaf, Red Yeast Rice and Olive in Cardiovascular Prevention
Official title: Extracts of Amla, Walnut Leaf, Red Yeast Rice and Olive in Cardiovascular Prevention: Efficacy and Tolerability of a Commercially Available Standardized Combination Preparation (Cholesfytol NG®) As Compared to Placebo in Patients with Hypercholesterolemia: a RDBPC Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: University Hospital, Antwerp
First posted: 2024-03-27
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate whether the use of a commercially available standardized combination preparation (Cholesfytol NG®), containing extracts of amla, walnut leaf, red yeast rice and olive, in individuals with hypercholesterolemia

1. Leads to a clinically relevant reduction of cholesterol levels, especially LDL,
2. Leads to a clinically relevant reduction of blood pressure on the short term,
3. Leads to a change in oxidative stress biomarkers.

Participants will be stratified by sex before randomization to one of the two treatments for 8 weeks:

* Cholesfytol NG: 500 mg Amla dry extract, 50 mg Walnut leaf dry extract, 33.6 mg Red yeast rice powder (equivalent to 1.45 mg monacolins), 25 mg Olive dry extract (equivalent to 5 mg of hydroxytyrosol) per day
* Placebo All treatments have an identical shape and color and should be used in the same way (oral intake; 3 capsules/day during dinner). No dietary instructions are given and participants are asked not to change their dietary habits, not to start other therapies (medication, supplements, slimming diets, extra physical activity, etc.) during their study period. Standardized questionnaires are used to obtain information on demographics, dietary habits and side effects. At baseline and after 8 weeks, 27 ml blood is drawn for various biological analyses, and blood pressure, BMI and waist circumference are measured.


Eligibility criteria: Inclusion Criteria:

* LDL ≥ 130 mg/dL

Exclusion Criteria:

* \<18 jaar
* \>76 jaar
* Smoking
* Use of nutritional supplements or (chronic) medication\*
* Triglycerides \> 400 mg/dL
* \> 14 alcoholic consumptions/week
* Chronic illness (e.g. diabetes, atherosclerosis, reumatoid arthritis)
* Acute infection
* Current pregnancy or pregnancy wish during the study period
* Breast feeding
* When nutritional supplements were used regularly, participation is allowed after a 10-day wash out period. Use of medication will be individually assessed and is permitted if it does not interfere with the used treatments and the patient is stable on the medication. Use of lipid lowering medication of food supplements is only permitted after a wash out period of at least 6 weeks.

Primary outcomes:
measure: Change from baseline LDL cholesterol at 8 weeks
timeFrame: Baseline, 8 weeks
Secondary outcomes:
measure: Frequency of side effects (+ their burden) as reported in the final questionnaire
timeFrame: 8 weeks
measure: Change from baseline Blood Pressure, Systolic at 8 weeks
timeFrame: Baseline, 8 weeks
measure: Change from baseline Blood Pressure, diastolic at 8 weeks
timeFrame: Baseline, 8 weeks
measure: Change from baseline total cholesterol level at 8 weeks
timeFrame: Baseline, 8 weeks
measure: Change from baseline HDL cholesterol level at 8 weeks
timeFrame: Baseline, 8 weeks
measure: Change from baseline non-HDL cholesterol level at 8 weeks
timeFrame: Baseline, 8 weeks
measure: Change from baseline Remnant Cholesterol at 8 weeks
timeFrame: Baseline, 8 weeks
measure: Change from baseline triglycerides level at 8 weeks
timeFrame: Baseline, 8 weeks
measure: Change from baseline Apo A1 level at 8 weeks
timeFrame: Baseline, 8 weeks
measure: Change from baseline Apo B level at 8 weeks
timeFrame: Baseline, 8 weeks
measure: Change from baseline lipoprotein A (LP(a)) level at 8 weeks
timeFrame: Baseline, 8 weeks
measure: Change from baseline OxLDL level at 8 weeks
timeFrame: Baseline, 8 weeks
measure: Change from baseline malondialdehyde (MDA) level at 8 weeks
timeFrame: Baseline, 8 weeks
measure: Change from baseline glutathion (GSH) level at 8 weeks
timeFrame: Baseline, 8 weeks
Other outcomes:
measure: Change from baseline glucose level at 8 weeks
timeFrame: Baseline, 8 weeks
measure: Change from baseline HbA1c level at 8 weeks
timeFrame: Baseline, 8 weeks
measure: Change from baseline insuline level at 8 weeks
timeFrame: Baseline, 8 weeks
measure: Change from baseline Body Mass Index (BMI) at 8 weeks
timeFrame: Baseline, 8 weeks
measure: Change from baseline waist circumference at 8 weeks
timeFrame: Baseline, 8 weeks
measure: Change from baseline hemoglobine level at 8 weeks
timeFrame: Baseline, 8 weeks
measure: Change from baseline creatinine level at 8 weeks
timeFrame: Baseline, 8 weeks
measure: Change from baseline hs-CRP level at 8 weeks
timeFrame: Baseline, 8 weeks
measure: Change from baseline homocysteine level at 8 weeks
timeFrame: Baseline, 8 weeks
measure: Change from baseline creatine kinase (CK) level at 8 weeks
timeFrame: Baseline, 8 weeks
measure: Change from baseline C-peptide level at 8 weeks
timeFrame: Baseline, 8 weeks
Locations:
city: Wilrijk
country: Belgium
facility: UAntwerp, NatuRAPT
state: Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Johan Bosmans, Prof. MD.
role: PRINCIPAL_INVESTIGATOR
References: