Effects of Arterin Cholesterol for Reduction of Lipid Levels

Not Applicable

• Conditions: Blood Cholesterol Lowers; LDL-C
• Interventions: Dietary Supplement: High Dose Arterin Cholesterol; Dietary Supplement: Low Dose Arterin Cholesterol; Dietary Supplement: Placebo

• Registration Number: NCT04749784
• Lead Sponsor: Perrigo CSCI

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-28
• Study Start: 2020-10-30
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-08
• Last Update Submitted: 2021-02-08
• Study First Posted: 2021-02-11
• Last Update Posted: 2021-02-11
• Primary Completion: 2021-06
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 114

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose IP	High Dose Arterin Cholesterol	Two tablets IP daily for 12 weeks
Low dose IP	Low Dose Arterin Cholesterol	One tablet IP + one tablet placebo daily for 12 weeks
Placebo	Placebo	Two tablets placebo daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
LDL-C levels between High Dose IP and placebo	12 weeks	Difference in LDL-C levels between High Dose IP and placebo at study end compared to baseline

Secondary Outcome Measures

Name	Time	Method
Difference between combined IP vs. placebo	12 weeks	Difference in global evaluation of benefit by the subject and investigator at study end between combined IP vs. placebo
Difference LDL-C levels between Low Dose IP and placebo	12 weeks	Difference in change of LDL-C levels between Low Dose IP and placebo at study end compared to baseline

Trial Locations

Locations (1)

analyze & realize GmbH; 🇩🇪 Berlin, Germany