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

NCT03340285 | Completed DMC

• 1 other identifier: AkP_6
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Reduction of LDL-Cholesterol levels

  4 weeks

Secondary Outcomes (5)

• Increasing of HDL-Cholesterol levels

  4 weeks

• Reduction of HbA1c levels

  4 weeks

• Reduction of fastin insuline levels

  4 weeks

• No alteration of transaminase levels

  4 weeks

• No alteration of CPK levels

  4 weeks

Study Arms (2)

AkP06

EXPERIMENTAL

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

Dietary Supplement: AkP06

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

AkP06 DIETARY_SUPPLEMENT

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

AkP06

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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 of AkP06
• Previous cardiovascular events
• Familiar severe dyslipidemia
• Familiar high cardiovascular risk Hepatic or muscular disorders Subjects receiving lipid-lowering drugs

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Raffaele Izzo

Naples, 80131, Italy

Location

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: November 8, 2017
• First Posted: November 13, 2017
• Study Start: December 1, 2017
• Primary Completion: March 31, 2018
• Study Completion: December 1, 2018
• Last Updated: July 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

IT (1)