Extracts of Amla, Walnut Leaf, Red Yeast Rice and Olive in Cardiovascular Prevention
NCT ID: NCT06333158
Last Updated: 2024-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
36 participants
INTERVENTIONAL
2024-03-22
2024-06-13
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cholesfytol NG
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
Cholesfytol NG
3 capsules a day with dinner.
Placebo
3 capsules daily (orally) with dinner taken for 8 weeks. Placebo contains magensium stearate, microcrystalline cellulose, colloidal silica and talc
Placebo
3 capsules a day with dinner
Interventions
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Cholesfytol NG
3 capsules a day with dinner.
Placebo
3 capsules a day with dinner
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* \>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.
18 Years
76 Years
ALL
No
Sponsors
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University Hospital, Antwerp
OTHER
Nina Hermans
OTHER
Responsible Party
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Nina Hermans
Professor
Principal Investigators
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Johan Bosmans, Prof. MD.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Antwerp
Locations
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UAntwerp, NatuRAPT
Wilrijk, Antwerp, Belgium
Countries
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Other Identifiers
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AmWaRO Study
Identifier Type: -
Identifier Source: org_study_id
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