NCT06333158CompletedPhase 4
Extracts of Amla, Walnut Leaf, Red Yeast Rice and Olive in Cardiovascular Prevention
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.
Source: ClinicalTrials.gov · Last updated 14 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 36 (actual)
- First submitted
- 20 Mar 2024
- Start date
- Mar 2024
- Primary completion date
- Jun 2024
- Lead sponsor
- Nina Hermans
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT06333158
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 36
- From Mar 2024 to the primary completion date, Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of nutritional supplements or (chronic) medication\*
- 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.
Other illness
- Chronic illness (e.g. diabetes, atherosclerosis, reumatoid arthritis)
- Acute infection
Lab values
- Triglycerides \> 400 mg/dL
Other
- \<18 jaar
- \>76 jaar
- Smoking
- \> 14 alcoholic consumptions/week
- Current pregnancy or pregnancy wish during the study period
- Breast feeding
Who the study is looking for
- LDL ≥ 130 mg/dL
Age in the registry: 18 years to 76 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UAntwerp, NatuRAPT Coordinator of this site? Confirm its status | Wilrijk | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.