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| Name | Class |
|---|---|
| Analyze & Realize | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose IP | Experimental | Two tablets IP daily for 12 weeks |
|
| Low dose IP | Experimental | One tablet IP + one tablet placebo daily for 12 weeks |
|
| Placebo | Placebo Comparator | Two tablets placebo daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Dose Arterin Cholesterol | Dietary Supplement | 240mg active ingredient daily |
| |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in tolerability parameters between groups | Changes in safety laboratory parameters at study end in comparison to V1 | 12 weeks |
| Difference in tolerability parameters between groups | Changes in vital signs throughout the study |
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:
Women of childbearing potential:
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:
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:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ralf Uebelhack, MD | Contact | +49 30/40 00 81 23 | ruebelhack@a-r.com |
| Name | Affiliation | Role |
|---|---|---|
| Ralf Uebelhack, MD | Analyze & Realize | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| analyze & realize GmbH | Recruiting | Berlin | 13467 | Germany |
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| Low Dose Arterin Cholesterol |
| Dietary Supplement |
120mg active ingredient daily |
|
| Placebo | Dietary Supplement | Placebo tablet |
|
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 |
| 12 weeks |
| Difference in tolerability parameters between groups | Assessment of adverse events throughout the study | 12 weeks |
| Difference in tolerability parameters between groups | Global evaluation of tolerability by subject and investigator at study end | 12 weeks |
| Difference in body weight between groups | Changes in body weight throughout the study | 12 weeks |
| Difference in dietary habits between groups | Changes in dietary habits throughout the study | 12 weeks |
| Difference in physical activity between groups | Changes in level of physical activity throughout the study | 12 weeks |