NCT05988099

Brief Summary

The aim of the study is to compare in a clinical condition the effect of standardized chokeberry extract in different formulations and a complex preparation containing chokeberry extract and other active ingredients in on the levels of selected markers associated with cardiovascular diseases in people with a predisposition to the development of these diseases.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

5 months

First QC Date

August 4, 2023

Last Update Submit

August 21, 2023

Conditions

HypertensionHypercholesterolemia

Keywords

HypertensionHypercholesterolemiaAronia extractChokeberry extract

Outcome Measures

Primary Outcomes (3)

  • Extended lipid panel (total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL), HDL and lipoprotein A, apolipoprotein Apo A1 and Apo B)

    Comparison of lipid panel markers

    baseline, 6 weeks

  • Glucose level

    Comparison of glucose level

    baseline, 6 weeks

  • Systolic, diatolic blood pressure

    Comparison of blood pressure

    baseline, 6 weeks

Secondary Outcomes (3)

  • Insulin level

    baseline, 6 weeks

  • Homocysteine level

    baseline, 6 weeks

  • Alanine aminotransferase (ALT), aspartate aminotransferase (AST)

    baseline, 6 weeks

Study Arms (4)

Complex product (chokeberry extract, L-arginine, vitamin E, vitamin A, folic acid, chromium)

EXPERIMENTAL

Single oral dose - 2 capsules

Dietary Supplement: Complex product

Chokeberry extract in liposomal formulation

ACTIVE COMPARATOR

Single oral dose - 2 capsules

Dietary Supplement: Chokeberry extract in liposomal formulation

Chokeberry extract in traditional formulation

ACTIVE COMPARATOR

Single oral dose - 2 capsules

Dietary Supplement: Chokeberry extract in traditional formulation

Placebo

PLACEBO COMPARATOR

Single oral dose - 2 capsules

Other: Placebo

Interventions

Complex productDIETARY_SUPPLEMENT

400 mg of chokeberry extract in liposomal formulation and L-arginine, vitamin E, vitamin A, folic acid, chromium

Complex product (chokeberry extract, L-arginine, vitamin E, vitamin A, folic acid, chromium)
Chokeberry extract in liposomal formulationDIETARY_SUPPLEMENT

400 mg of chokeberry extract in liposomal formulation

Chokeberry extract in liposomal formulation
Chokeberry extract in traditional formulationDIETARY_SUPPLEMENT

400 mg of chokeberry extract in traditional formulation

Chokeberry extract in traditional formulation
PlaceboOTHER

Placebo

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women and men, 18-55 years old
  • Patients with known: hypertension or hypercholesterolemia,
  • Patients on hypotensive or hypolipemic therapy for at least 6 months prior to study enrollment
  • Signed informed consent

You may not qualify if:

  • Intake of supplements containing plant extracts, polyphenols or anthocyanins,
  • Intake of supplements with antioxidant properties,
  • Participation in another clinical trial,
  • Women who are pregnant, planning to become pregnant during the study, or breastfeeding,
  • Oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis, leukemia, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplant,
  • Patients receiving glucocorticosteroids, anti-allergic drugs, non-steroidal anti-inflammatory drugs in exacerbations of chronic disease.
  • Patients with signs of inflammation such as increased body temperature, redness, swelling, pain.
  • Patients who have not given written consent to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centum Zdrowia Eter-Med sp. z o.o.

Gdansk, 80-822, Poland

Location

MeSH Terms

Conditions

HypertensionHypercholesterolemia

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2023

First Posted

August 14, 2023

Study Start

February 20, 2023

Primary Completion

July 28, 2023

Study Completion

July 28, 2023

Last Updated

August 23, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)