NCT02898805

Brief Summary

The study is designed to compare the effects of two combination of nutraceuticals: Armolipid Plus® and LopiGLIK® (Akademy Pharma), a new supplement that, in addition to Berberine and Red Rice, contains Morus Alba's extract. The study will analyze the impact of 16 week treatment with one of the combinations, according to a randomized scheme, on metabolic parameters in dyslipidemic subjects that do not require or not tolerate a statin therapy. In particular, it will assess the ability of the two combinations to reduce the levels of total and LDL cholesterol, HbA1C, glicaemia and insulin and increase those of HDL cholesterol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

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

January 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 30, 2019

Status Verified

July 1, 2019

Enrollment Period

2 years

First QC Date

September 8, 2016

Last Update Submit

July 29, 2019

Conditions

Cardiovascular Risk Factors

Outcome Measures

Primary Outcomes (1)

  • Reduction of LDL-Cholesterol levels

    16 weeks

Secondary Outcomes (3)

  • Increasing of HDL-Cholesterol levels

    16 weeks

  • Reduction of HbA1c levels

    16 weeks

  • Reduction of fastin insuline levels

    16 weeks

Study Arms (2)

LopiGLIK®

EXPERIMENTAL

first two weeks: Placebo + prescribed Diet then 16 weeks LopiGLIK® a tablet/day after a meal + Diet

Other: PlaceboOther: Prescribed DietDietary Supplement: LopiGLIK®

Armolipid Plus

ACTIVE COMPARATOR

first two weeks: Placebo + prescribed Diet then 16 weeks Armolipid Plus a tablet/day after a meal + Diet

Other: PlaceboOther: Prescribed DietDietary Supplement: Armolipid Plus

Interventions

PlaceboOTHER
Armolipid PlusLopiGLIK®
Prescribed DietOTHER
Armolipid PlusLopiGLIK®
LopiGLIK®DIETARY_SUPPLEMENT
LopiGLIK®
Armolipid PlusDIETARY_SUPPLEMENT
Armolipid Plus

Eligibility Criteria

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

You may qualify if:

  • Total Cholesterol\<300 mg/dL
  • Total Cholesterol\>200 mg/dL
  • Cardiovascular Risk\<20%

You may not qualify if:

  • Pregnancy
  • Documented intolerance to one or more 'components LOPIGLIK / Armolipid PLUS
  • Previous cardiovascular events
  • Familiar severe dyslipidemia
  • Familiar high cardiovascular risk Hepatic or muscular disorders Subjects receiving lipid-lowering drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federico II University

Naples, 80131, Italy

Location

Related Publications (3)

  • Trimarco V, Izzo R, Stabile E, Rozza F, Santoro M, Manzi MV, Serino F, Schiattarella GG, Esposito G, Trimarco B. Effects of a new combination of nutraceuticals with Morus alba on lipid profile, insulin sensitivity and endotelial function in dyslipidemic subjects. A cross-over, randomized, double-blind trial. High Blood Press Cardiovasc Prev. 2015 Jun;22(2):149-54. doi: 10.1007/s40292-015-0087-2. Epub 2015 Apr 14.

    PMID: 25870124RESULT

  • Carrizzo A, Ambrosio M, Damato A, Madonna M, Storto M, Capocci L, Campiglia P, Sommella E, Trimarco V, Rozza F, Izzo R, Puca AA, Vecchione C. Morus alba extract modulates blood pressure homeostasis through eNOS signaling. Mol Nutr Food Res. 2016 Oct;60(10):2304-2311. doi: 10.1002/mnfr.201600233. Epub 2016 Jun 27.

    PMID: 27234065RESULT

  • Manfrin A, Trimarco V, Manzi MV, Rozza F, Izzo R. A single blind, multicenter, randomized controlled trial to evaluate the effectiveness and cost of a novel nutraceutical (LopiGLIK(R)) lowering cardiovascular disease risk. Clinicoecon Outcomes Res. 2018 Oct 8;10:601-609. doi: 10.2147/CEOR.S172838. eCollection 2018.

    PMID: 30349338DERIVED

Study Officials

  • Bruno Trimarco, Professor

    FEDERICO II UNIVERSITY - NAPLES

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PROF OF CARDIOLOGY

Study Record Dates

First Submitted

September 8, 2016

First Posted

September 13, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2018

Study Completion

December 1, 2018

Last Updated

July 30, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will share

Data available to principal investigator

Locations

IT(1)