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Effects of a New Combination of Nutraceuticals (AkP06) Without Monacolin K on Plasma Lipids and Glucose

NCT03340285 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2019-07-30

No results posted yet for this study

Summary

The study is designed evaluate the effects of a new combination of nutraceuticals (AkP 06) without Monacolin K on lipid and glucose metabolism.

The study will analyze the impact of 4 weeks treatment with Akp06 or placebo, 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 AkP 06 to reduce the plasma levels of LDL cholesterol, HbA1C, glicaemia and fasting insulin and to increase those of HDL cholesterol.

In addition, effects on serum transaminase and creatine phosphokinase (CPK) concentration will be evaluated.

Conditions

  • Cardiovascular Risk Factor

Interventions

DIETARY_SUPPLEMENT

AkP06

first 2 weeks: Placebo + Diet then 4 weeks AkP06 two tablet/day before meals + Diet

DIETARY_SUPPLEMENT

Placebo

first 2 weeks: Placebo + Diet then 4 weeks placebo two tablet/day before meals + Diet

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Principal Investigators

  • Bruno Trimarco, Professor · FEDERICO II UNIVERSITY - NAPLES

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2018-03-31
Completion
2018-12-01

Countries

  • Italy

Study Locations

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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 NCT03340285 on ClinicalTrials.gov