Effects of Arterin Cholesterol for Reduction of Lipid Levels

NCT ID: NCT04749784

Last Updated: 2021-02-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-30
• Study Completion Date: 2021-06-30

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.

Conditions

Blood Cholesterol Lowers; LDL-C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

High dose IP

Two tablets IP daily for 12 weeks

Group Type: EXPERIMENTAL

High Dose Arterin Cholesterol

Intervention Type: DIETARY_SUPPLEMENT

240mg active ingredient daily

Low dose IP

One tablet IP + one tablet placebo daily for 12 weeks

Group Type: EXPERIMENTAL

Low Dose Arterin Cholesterol

Intervention Type: DIETARY_SUPPLEMENT

120mg active ingredient daily

Placebo

Two tablets placebo daily for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo tablet

Interventions

High Dose Arterin Cholesterol

240mg active ingredient daily

Intervention Type: DIETARY_SUPPLEMENT

Low Dose Arterin Cholesterol

120mg active ingredient daily

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo tablet

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Analyze & Realize

NETWORK

Sponsor Role: collaborator

Perrigo CSCI

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ralf Uebelhack, MD

Role: PRINCIPAL_INVESTIGATOR

Analyze & Realize

Locations

analyze & realize GmbH

Berlin, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Ralf Uebelhack, MD

Role: CONTACT

ruebelhack@a-r.com

+49 30/40 00 81 23

Facility Contacts

Ralf Uebelhack, MD

Role: primary

Other Identifiers

PERI/002620

Identifier Type: -

Identifier Source: org_study_id