Effects of Arterin Cholesterol for Reduction of Lipid Levels

Study Overview
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Brief Summary
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The main objective of this double-blind, randomised, placebo-controlled study is to assess the benefit and tolerability of Arterin Cholesterol in subjects with elevated lipid levels within a 12-week period of use.

Official Title
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Double-blind, Randomised, Placebo-controlled Study to Evaluate the Benefit and Tolerability of Arterin Cholesterol for Reduction of Lipid Levels

Conditions
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Blood Cholesterol Lowers, LDL-C

Intervention / Treatment
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* Dietary Supplement: High Dose Arterin Cholesterol
* Dietary Supplement: Low Dose Arterin Cholesterol
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females 18 to 65 years old BMI 25 - 29.9 kg/m2 Generally in good health LDL-C level between 3.359-4.884 mmol/L (130-189 mg/dL) Stable body weight for at least 3 months prior to study inclusion (<3 kg weight change) (self-reported) Not smoking, at least 6 months prior to study inclusion and throughout the study Electrocardiogram (ECG) without pathological findings at V1 Readiness and ability to comply with study requirements, in particular: to take IP as recommended to avoid the use of any nutritional, medical and further interventional options for reduction/maintenance of lipid levels during the study (other than the IP) to avoid consumption of grapefruit, but otherwise keep the dietary habits to keep the habitual level of physical activity during the study Women of childbearing potential: commitment to use contraception methods negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1 Readiness not to participate in another clinical study during this study Exclusion Criteria: Known allergy or hypersensitivity to the components of the investigational product LDL-C level ≥4.910 mmol/L (≥190 mg/dL) Total cholesterol level ≥7.254 mmol/L (≥280 mg/dL) Triglyceride level ≥2.851 mmol/L (≥250 mg/dL) HDL-C level <1.034 mmol/L (<40 mg/dL) Known genetic hyperlipidemia Known family history of dyslipidemia History and/or presence of clinically significant known (self-reported) condition/disorder, which per investigator's judgement could interfere with the results of the study or the safety of the subject, e.g.: cardiovascular disease/disorder (myocardial infarction, angina pectoris, stroke, heart failure, arrhythmia) within 6 months or requiring percutaneous coronary intervention or coronary artery bypass surgery untreated or non-stabilised thyroid gland disorder untreated or non-stabilised hypertension (regular systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg) acute or chronic gastrointestinal (GI) disease or digestion/absorption disorders (e.g. inflammatory bowel disease, coeliac disease, pancreatitis etc.) untreated/non-stabilised diabetes mellitus type 1 or 2 acute or chronic psychotic disorder any other relevant serious diseases Deviation of safety laboratory parameter(s) at V1 that is: clinically significant or >2x upper limit of normal, unless the deviation is justified by a previously known not clinically relevant condition (e.g. Gilbert's syndrome) Regular medication and/or supplementation and/or treatment (including any natural health products) within the last 2 months prior to V1 and during the study, as per investigator judgement: lipid lowering products (known to affect lipid metabolism, platelet function, antioxidant status, etc.), including dietary or health supplements (e.g. omega-3 fatty acids, calcium, oat fiber, niacin, green tea extract, plant sterols, soy protein, psyllium seed husk, probiotics/prebiotics) products that can influence cholesterol levels (e.g. corticosteroids, beta blockers, amiodarone, estrogen, anabolic steroids), unless it is long term and stabilised (contraceptives are allowed in case of a stable continuous intake before and during the study) that could influence gastrointestinal functions (e.g. laxatives, opioids, anticholinergics etc.) any other, which could interfere with the results of the study or the safety of the subject Women of childbearing potential: pregnancy or nursing History of or current abuse of drugs, alcohol or medication Participation in another study during the last 30 days prior to V1 Any other reason for exclusion as per investigator's judgment, e.g. insufficient compliance with study procedures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High dose IP<br>Two tablets IP daily for 12 weeks | Dietary Supplement: High Dose Arterin Cholesterol<br>* 240mg active ingredient daily<br>|
| Experimental: Low dose IP<br>One tablet IP + one tablet placebo daily for 12 weeks | Dietary Supplement: Low Dose Arterin Cholesterol<br>* 120mg active ingredient daily<br>|
| Placebo Comparator: Placebo<br>Two tablets placebo daily for 12 weeks | Dietary Supplement: Placebo<br>* Placebo tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-C levels between High Dose IP and placebo | Difference in LDL-C levels between High Dose IP and placebo at study end compared to baseline | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference LDL-C levels between Low Dose IP and placebo | Difference in change of LDL-C levels between Low Dose IP and placebo at study end compared to baseline | 12 weeks | 
| Difference between combined IP vs. placebo | Difference in LDL-C levels at V3, V4 and V5 between combined IP vs. placebo | 12 weeks | 
| Difference between combined IP vs. placebo | Difference in change in LDL-C levels at V3, V4 and V5, each in comparison to V2 between combined IP vs. placebo | 12 weeks | 
| Difference between combined IP vs. placebo | Difference in TC levels at V3, V4 and V5 between combined IP vs. placebo | 12 weeks | 
| Difference between combined IP vs. placebo | Difference in change in TC levels at V3, V4 and V5, each in comparison to V2 between combined IP vs. placebo | 12 weeks | 
| Difference between combined IP vs. placebo | Difference in TG levels at V3, V4 and V5 between combined IP vs. placebo | 12 weeks | 
| Difference between combined IP vs. placebo | Difference in change in TG levels at V3, V4 and V5, each in comparison to V2 between combined IP vs. placebo | 12 weeks | 
| Difference between combined IP vs. placebo | Difference in HDL-C levels at V3, V4 and V5 between combined IP vs. placebo | 12 weeks | 
| Difference between combined IP vs. placebo | Difference in change in HDL-C levels at V3, V4 and V5, each in comparison to V2 between combined IP vs. placebo | 12 weeks | 
| Difference between combined IP vs. placebo | Difference in LDL-C/HDL-C ratio at V3, V4 and V5 between combined IP vs. placebo | 12 weeks | 
| Difference between combined IP vs. placebo | Difference in change in LDL-C/HDL-C ratio at V3, V4 and V5, each in comparison to V2 between combined IP vs. placebo | 12 weeks | 
| Difference between combined IP vs. placebo | Difference in SCORE value at V3, V4 and V5 between combined IP vs. placebo | 12 weeks | 
| Difference between combined IP vs. placebo | Difference in change in SCORE value at V3, V4 and V5, each in comparison to V2 between combined IP vs. placebo | 12 weeks | 
| Difference between combined IP vs. placebo | Difference in global evaluation of benefit by the subject and investigator at study end between combined IP vs. placebo | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nutritional supplement