Extracts of Amla, Walnut Leaf, Red Yeast Rice and Olive in Cardiovascular Prevention
- Conditions
- Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia
- Interventions
- Dietary Supplement: Cholesfytol NGOther: Placebo
- Registration Number
- NCT06333158
- Lead Sponsor
- Nina Hermans
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- LDL ≥ 130 mg/dL
- <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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cholesfytol NG Cholesfytol NG - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change from baseline LDL cholesterol at 8 weeks Baseline, 8 weeks Calculated from Total Cholesterol, HDL Cholesterol and Triglycerides
- Secondary Outcome Measures
Name Time Method Change from baseline Blood Pressure, Systolic at 8 weeks Baseline, 8 weeks average of 3 measurements during 15 minutes
Change from baseline Blood Pressure, diastolic at 8 weeks Baseline, 8 weeks average of 3 measurements during 15 minutes
Change from baseline triglycerides level at 8 weeks Baseline, 8 weeks Measurement in Serum
Change from baseline lipoprotein A (LP(a)) level at 8 weeks Baseline, 8 weeks Measurement in Serum
Change from baseline Apo A1 level at 8 weeks Baseline, 8 weeks Measurement in Serum
Change from baseline total cholesterol level at 8 weeks Baseline, 8 weeks Measurement in Serum
Frequency of side effects (+ their burden) as reported in the final questionnaire 8 weeks Unvalidated but standardized questionnaire on typical statin-related side effects
Change from baseline HDL cholesterol level at 8 weeks Baseline, 8 weeks Measurement in Serum
Change from baseline Apo B level at 8 weeks Baseline, 8 weeks Measurement in Serum
Change from baseline OxLDL level at 8 weeks Baseline, 8 weeks Measurement with ELISA
Change from baseline malondialdehyde (MDA) level at 8 weeks Baseline, 8 weeks Measurement with ELISA
Change from baseline glutathion (GSH) level at 8 weeks Baseline, 8 weeks Measurement with in house HPLC method
Change from baseline non-HDL cholesterol level at 8 weeks Baseline, 8 weeks Calculated from HDL and total cholesterol
Change from baseline Remnant Cholesterol at 8 weeks Baseline, 8 weeks Calculated from total, HDL and LDL cholesterol
Trial Locations
- Locations (1)
UAntwerp, NatuRAPT
🇧🇪Wilrijk, Antwerp, Belgium