NCT03425630

Brief Summary

The aim of this study was to assess the lipid-lowering activity and safety of a dietary supplement containing monacolin K, L-arginine, coenzyme Q10 and ascorbic acid (vitamin C). Twenty both gender caucasian outpatients aged 18-75 yrs with serum LDL-C between130-180 mg/dL, not significantly modified by an appropriate dietetic regimen assumed two different dietary supplements (Argicolina \[trade mark\]: A; Normolip 5 \[trade mark\]: N) both containing monacolin K 10 mg for 8 weeks each separated by a 4-week wash-out period in a single center, controlled, randomized, open-label, cross-over clinical study. Exclusion criteria were pregnancy or breast-feeding; known liver, renal or muscle diseases; serum triglycerides (TG) greater than 350 mg/dL; previous cardiovascular events; concomitant neoplastic or immunodepressive disease; use of lipid-lowering drugs or dietary supplements within the last three weeks; concurrent use of thiazide diuretics, oral contraceptives containing estrogen or progestogen, systemic corticosteroids; use of psycho-active substances, drug or alcohol abuse; neurological or psychiatric diseases that could affect consent validity or impair the patient's adherence to the study protocol. Evaluation criteria were Tot-C, LDL-C, HDL-cholesterol, TG, fasting blood glucose, aspartate aminotransferase, alanine aminotransferase, creatinkinase, gamma-glutamyl-transpeptidase, humeral blood pressure and heart rate measured at the start and a the end of each treatment period. Safety was monitored through the study.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

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

July 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 7, 2018

Completed
Last Updated

February 12, 2018

Status Verified

February 1, 2018

Enrollment Period

9 months

First QC Date

January 24, 2018

Last Update Submit

February 9, 2018

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • reduction of LDL-cholesterol

    The primary efficacy variable was the LDL-C change between the start and the end (8 weeks)of each treatment period, expressed as a percentage of the initial value

    8 weeks

Secondary Outcomes (3)

  • Total cholesterol reduction

    8 weeks

  • Triglycerides reduction

    8 weeks

  • HDL cholesterol increase

    8 weeks

Study Arms (2)

Argicolina (cross-over vs Normolip)

EXPERIMENTAL

Argicolina is a dietary supplement containing monacolin (sachets)

Dietary Supplement: ArgicolinaDietary Supplement: Normolip

Normolip (cross-over vs Argicolina)

ACTIVE COMPARATOR

Normolip is a dietary supplement containing monacolin (tablets)

Dietary Supplement: ArgicolinaDietary Supplement: Normolip

Interventions

ArgicolinaDIETARY_SUPPLEMENT

8 weeks

Argicolina (cross-over vs Normolip)Normolip (cross-over vs Argicolina)
NormolipDIETARY_SUPPLEMENT

8 weeks

Argicolina (cross-over vs Normolip)Normolip (cross-over vs Argicolina)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • serum LDL-C between130-180 mg/dL, not significantly modified by an appropriate dietetic regimen

You may not qualify if:

  • pregnancy or breast-feeding
  • known liver, renal or muscle diseases
  • serum triglycerides (TG) greater than 350 mg/dL
  • previous cardiovascular events
  • concomitant neoplastic or immunodepressive disease
  • use of lipid-lowering drugs or dietary supplements within the last 3 weeks
  • concurrent use of thiazide diuretics, oral contraceptives containing estrogen or progestogen, systemic corticosteroids
  • use of psycho-active substances, drug or alcohol abuse
  • neurological or psychiatric diseases that could affect consent validity or impair the patient's adherence to the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Magno S, Ceccarini G, Pelosini C, Jaccheri R, Vitti J, Fierabracci P, Salvetti G, Airoldi G, Minale M, Saponati G, Santini F. LDL-cholesterol lowering effect of a new dietary supplement: an open label, controlled, randomized, cross-over clinical trial in patients with mild-to-moderate hypercholesterolemia. Lipids Health Dis. 2018 May 24;17(1):124. doi: 10.1186/s12944-018-0775-8.

    PMID: 29793488DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ferruccio Santini, Prof.

    Endrinology Unit 1; Cisanello Hospital, Pisa (Italy)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2018

First Posted

February 7, 2018

Study Start

July 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

February 12, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share