Effect of a Treatment With a Nutraceutical Combination on Sub-optimal LDL Cholesterol Levels

NCT03739242 | Completed Results

• 1 other identifier: MEIF/MOF-Col/001
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

High cholesterol is one of the major controllable risk factor for coronary heart disease. It is well demonstrated that drugs that reduce the intestinal absorption of cholesterol or block the synthesis of cholesterol or the association of both, can reduce cholesterol and reduce rate of cardiovascular events. The trial will evaluate natural alternative to this drug approach testing the effects of a combination of phytosterol, a nutritional that reduce cholesterol absorption, and fermented red rice, a nutritional that reduce the synthesis of cholesterol. Subjects with sub optimal blood cholesterol levels, matching all the inclusion criteria and none of the exclusion criteria, will be treated for 8 weeks with a nutraceutical combination of phytosterols and fermented red rice and will have to maintain, during the entire duration of the study, the Mediterranean-style diet provided. The study will evaluate as primary objective the changes in LDL cholesterol blood levels and more in general the modulation of lipid profile and of others clinical parameters as well as the tolerability.

Conditions

Hypercholesterolemia

Keywords

Lipids; Cholesterol; Triglycerides; Dyslipidemia; Low density lipoprotein cholesterol; Dietary Fats; Hyperlipidemias; Dietary Supplements; Food Supplements; Nutraceuticals; Nutriceuticals

Outcome Measures

Primary Outcomes (1)

• Change in Blood LDL Cholesterol Level

  Mean change in blood LDL cholesterol level from randomization (day 0) to V4 (week 8)

  From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment

Secondary Outcomes (15)

• Change in Total Blood Cholesterol Level

  From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment

• Change in Blood HDL Cholesterol Level

  From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment

• Change in Blood Non-HDL Cholesterol Level

  From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment

• Change in Blood Triglycerides Level

  From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment

• Change in Blood Apolipoprotein B Level

  From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment

Study Arms (2)

Nutraceutical combination

EXPERIMENTAL

One film-coated tablet (1300 mg) per os per day to be taken in the evening. Each tablet contains phytosterols 800 mg, Monascus purpureus (167 mg) titrated at 3% in monacolin K (5 mg), niacin 27 mg, linear aliphatic alcohols titrated to 60% octacosanol.

Dietary Supplement: Nutraceutical combination

Placebo

PLACEBO COMPARATOR

One film-coated tablet (1300 mg) per os per day to be taken in the evening. Placebo tablets identical in appearance, size, shape, weight and taste to the active product.

Other: Placebo

Interventions

Nutraceutical combination DIETARY_SUPPLEMENT

One tablet per os per day to be taken in the evening from randomization (day 0) to the end of the trial (day 56 +/- 3)

Nutraceutical combination

Placebo OTHER

One tablet per os per day to be taken in the evening from randomization (day 0) to the end of the trial (day 56 +/- 3)

Placebo

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 30-75 years
• LDL-cholesterol = 115 -190 mg/dL
• Triglycerides \< 400 mg/dL
• Any cardiovascular therapy should be stable for type and dose for at least three months
• Signed, written informed consent

You may not qualify if:

• Intolerance to any ingredient of dietary supplement
• Patients already suffering from cardiovascular diseases or at high risk of developing cardiovascular diseases
• Myopathies
• Uncontrolled diabetes mellitus based on PI judgment
• Chronic renal failure \[defined as estimated glomerular filtration rate (eGFR) \<60ml/min/1.73m2\] or liver failure \[defined as aspartate aminotransferase (AST) and /or Alanine Aminotransferase (ALT) \>3 upper limit of normal (ULN)\]
• Body Mass Index \> 32 kg/m2
• Therapy with statins or other drugs or supplements with effects on lipid metabolism
• Patients with acquired immunodeficiency
• Treatment with immunosuppressants
• Pregnant or breastfeeding women
• Women of childbearing potential not willing to use effective birth control methods
• Patients participating or having participated in another clinical trial within the previous 3 months
• Current or recent history of drug or alcohol addiction based on PI judgment

Sponsors & Collaborators

• A. Menarini Industrie Farmaceutiche Riunite S.r.l.: lead

Study Sites (1)

Policlinico S.Orsola - Malpighi Medicina Interna Borghi

Bologna, 40138, Italy

Location

Related Publications (1)

• Cicero AFG, D'Addato S, Borghi C. A Randomized, Double-Blinded, Placebo-Controlled, Clinical Study of the Effects of a Nutraceutical Combination (LEVELIP DUO(R)) on LDL Cholesterol Levels and Lipid Pattern in Subjects with Sub-Optimal Blood Cholesterol Levels (NATCOL Study). Nutrients. 2020 Oct 14;12(10):3127. doi: 10.3390/nu12103127.

  PMID: 33066334 DERIVED

MeSH Terms

Conditions

Hypercholesterolemia; Dyslipidemias; Hyperlipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

No limitations or caveats are applicable to this summary

Results Point of Contact

• Title: Dr Paolo Fabrizzi Clinical Operation Director
• Organization: A. Menarini Industrie Farmaceutiche Riunite SrL

pfabrizzi@menarini.it

+39 055 5680459

Study Officials

• Claudio Borghi, Professor

  Policlinico S.Orsola - Malpighi Medicina Interna Borghi

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: November 13, 2018
• Study Start: October 12, 2017
• Primary Completion: August 29, 2018
• Study Completion: August 29, 2018
• Last Updated: October 14, 2019
• Results First Posted: October 14, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)