Extracts of Amla, Walnut Leaf, Red Yeast Rice and Olive in Cardiovascular Prevention

NCT06333158 | Completed Phase 4

• 1 other identifier: AmWaRO Study
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

• 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

Outcome Measures

Primary Outcomes (1)

• Change from baseline LDL cholesterol at 8 weeks

  Calculated from Total Cholesterol, HDL Cholesterol and Triglycerides

  Baseline, 8 weeks

Secondary Outcomes (14)

• Frequency of side effects (+ their burden) as reported in the final questionnaire

  8 weeks

• Change from baseline Blood Pressure, Systolic at 8 weeks

  Baseline, 8 weeks

• Change from baseline Blood Pressure, diastolic at 8 weeks

  Baseline, 8 weeks

• Change from baseline total cholesterol level at 8 weeks

  Baseline, 8 weeks

• Change from baseline HDL cholesterol level at 8 weeks

  Baseline, 8 weeks

Other Outcomes (11)

• Change from baseline glucose level at 8 weeks

  Baseline, 8 weeks

• Change from baseline HbA1c level at 8 weeks

  Baseline, 8 weeks

• Change from baseline insuline level at 8 weeks

  Baseline, 8 weeks

Study Arms (2)

Cholesfytol NG

EXPERIMENTAL

3 capsules daily (orally) with dinner containing in total 1000 mg of Amla dry extract, 100 mg of Walnut leaf dry extract, 67.2 mg of Red yeast rice powder (equivalent to 2.9 mg of monacolines), 50 mg of olive fruit dry extract (equivalent to 10 mg of hydroxytyrosol). Taken for 8 weeks

Dietary Supplement: Cholesfytol NG

Placebo

PLACEBO COMPARATOR

3 capsules daily (orally) with dinner taken for 8 weeks. Placebo contains magensium stearate, microcrystalline cellulose, colloidal silica and talc

Other: Placebo

Interventions

Cholesfytol NG DIETARY_SUPPLEMENT

3 capsules a day with dinner.

Cholesfytol NG

Placebo OTHER

3 capsules a day with dinner

Placebo

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• LDL ≥ 130 mg/dL

You may not qualify if:

• \<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.

Sponsors & Collaborators

• Nina Hermans: lead
• University Hospital, Antwerp: collaborator

Study Sites (1)

UAntwerp, NatuRAPT

Wilrijk, Antwerp, 2610, Belgium

Location

Study Officials

• Johan Bosmans, Prof. MD.

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 27, 2024
• Study Start: March 22, 2024
• Primary Completion: June 13, 2024
• Study Completion: June 13, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)