NCT06333158

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Nina Hermans · Academic / Other
• Sex: All
• Age: 18 Years – 76 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Cholesfytol NG	3 capsules a day with dinner.
OTHER	Placebo	3 capsules a day with dinner

Timeline

• Start date: 2024-03-22
• Primary completion: 2024-06-13
• Completion: 2024-06-13
• First posted: 2024-03-27
• Last updated: 2024-11-14

Locations

1 site across 1 country: Belgium