Effects of Arterin Cholesterol for Reduction of Lipid Levels

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

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.

Study Overview

• Status: Recruiting
• Conditions: Blood Cholesterol Lowers; LDL-C
• Intervention / Treatment: Dietary supplement: High Dose Arterin Cholesterol; Dietary supplement: Low Dose Arterin Cholesterol; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 114
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ralf Uebelhack, MD; Phone Number: +49 30/40 00 81 23; Email: ruebelhack@a-r.com

Study Locations

• Germany
  • Berlin, Germany, 13467
    • Recruiting
    • Analyze & Realize GmbH
    • Contact: Ralf Uebelhack, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High dose IP; Two tablets IP daily for 12 weeks	Dietary supplement: High Dose Arterin Cholesterol; 240mg active ingredient daily
Experimental: Low dose IP; One tablet IP + one tablet placebo daily for 12 weeks	Dietary supplement: Low Dose Arterin Cholesterol; 120mg active ingredient daily
Placebo Comparator: Placebo; Two tablets placebo daily for 12 weeks	Dietary supplement: Placebo; Placebo tablet

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Perrigo CSCI
• Collaborators: Analyze & Realize
• Investigators: Principal Investigator: Ralf Uebelhack, MD, Analyze & Realize

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2020
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: October 28, 2020
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (Actual): February 11, 2021

Study Record Updates

• Last Update Posted (Actual): February 11, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: nutritional supplement
• Other Study ID Numbers: PERI/002620

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No