MedTrace Logo

LDL-cholesterol Lowering Effect of a New Dietary Supplement

NCT03425630 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-02-12

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Argicolina

8 weeks

DIETARY_SUPPLEMENT

Normolip

8 weeks

Sponsors & Collaborators

  • Ispharm srl

    lead OTHER

Principal Investigators

  • Ferruccio Santini, Prof. · Endrinology Unit 1; Cisanello Hospital, Pisa (Italy)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-04-30
Completion
2017-04-30

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03425630 on ClinicalTrials.gov