Clinical trial NCT04749784: Effects of Arterin Cholesterol for Reduction of Lipid Levels
Official title: Double-blind, Randomised, Placebo-controlled Study to Evaluate the Benefit and Tolerability of Arterin Cholesterol for Reduction of Lipid Levels
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Cholesterol Lowers
LDL-C
Keywords: nutritional supplement
Lead sponsor: Perrigo CSCI
Sponsor class: INDUSTRY
Collaborators: name: Analyze & Realize
First posted: 2021-02-11
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Males and females
2. 18 to 65 years old
3. BMI 25 - 29.9 kg/m2
4. Generally in good health
5. LDL-C level between 3.359-4.884 mmol/L (130-189 mg/dL)
6. Stable body weight for at least 3 months prior to study inclusion (\<3 kg weight change) (self-reported)
7. Not smoking, at least 6 months prior to study inclusion and throughout the study
8. Electrocardiogram (ECG) without pathological findings at V1
9. 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
10. Women of childbearing potential:

    * commitment to use contraception methods
    * negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1
11. Readiness not to participate in another clinical study during this study

Exclusion Criteria:

1. Known allergy or hypersensitivity to the components of the investigational product
2. LDL-C level ≥4.910 mmol/L (≥190 mg/dL)
3. Total cholesterol level ≥7.254 mmol/L (≥280 mg/dL)
4. Triglyceride level ≥2.851 mmol/L (≥250 mg/dL)
5. HDL-C level \<1.034 mmol/L (\<40 mg/dL)
6. Known genetic hyperlipidemia
7. Known family history of dyslipidemia
8. 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
9. 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)
10. 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
11. Women of childbearing potential: pregnancy or nursing
12. History of or current abuse of drugs, alcohol or medication
13. Participation in another study during the last 30 days prior to V1
14. Any other reason for exclusion as per investigator's judgment, e.g. insufficient compliance with study procedures

Primary outcomes:
measure: LDL-C levels between High Dose IP and placebo
timeFrame: 12 weeks
Secondary outcomes:
measure: Difference LDL-C levels between Low Dose IP and placebo
timeFrame: 12 weeks
measure: Difference between combined IP vs. placebo
timeFrame: 12 weeks
measure: Difference between combined IP vs. placebo
timeFrame: 12 weeks
measure: Difference between combined IP vs. placebo
timeFrame: 12 weeks
measure: Difference between combined IP vs. placebo
timeFrame: 12 weeks
measure: Difference between combined IP vs. placebo
timeFrame: 12 weeks
measure: Difference between combined IP vs. placebo
timeFrame: 12 weeks
measure: Difference between combined IP vs. placebo
timeFrame: 12 weeks
measure: Difference between combined IP vs. placebo
timeFrame: 12 weeks
measure: Difference between combined IP vs. placebo
timeFrame: 12 weeks
measure: Difference between combined IP vs. placebo
timeFrame: 12 weeks
measure: Difference between combined IP vs. placebo
timeFrame: 12 weeks
measure: Difference between combined IP vs. placebo
timeFrame: 12 weeks
measure: Difference between combined IP vs. placebo
timeFrame: 12 weeks
Other outcomes:
measure: Difference in tolerability parameters between groups
timeFrame: 12 weeks
measure: Difference in tolerability parameters between groups
timeFrame: 12 weeks
measure: Difference in tolerability parameters between groups
timeFrame: 12 weeks
measure: Difference in tolerability parameters between groups
timeFrame: 12 weeks
measure: Difference in body weight between groups
timeFrame: 12 weeks
measure: Difference in dietary habits between groups
timeFrame: 12 weeks
measure: Difference in physical activity between groups
timeFrame: 12 weeks
Locations:
city: Berlin
country: Germany
facility: analyze & realize GmbH
Study officials:
affiliation: Analyze & Realize
name: Ralf Uebelhack, MD
role: PRINCIPAL_INVESTIGATOR
References: