Effects of a Combined Nutraceutical on Lipid Pattern, Glucose Metabolism and Inflammatory Parameters in Moderately Hypercholesterolemic Subjects: A Double-blind, Cross-over, Randomized Clinical Trial
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BACKGROUND: There is an increasing interest for combined nutraceuticals that can act on several points of lipid and glucose metabolism with preventive purposes. However, the simple assemblage of nutraceuticals with potentially additive mechanism of action need to be clinically tested. METHODS: To assess the effects of a combination of nutraceuticals based on artichoke, red yeast rice, banaba, and coenzyme Q10, we performed a double bind, cross-over designed trial versus placebo in 30 adults with LDL cholesterol suboptimal in primary prevention of cardiovascular disease. After a period of 3 weeks of dietary habits correction, patients began a period of 6 weeks of treatment with nutraceutical or placebo, followed by 2 weeks of washout and finally 6 weeks in cross-over. Data related to lipid pattern, insulin resistance, renal function, liver and CPK have been obtained at each visit. RESULTS: In particular, the after the nutraceutical treatment the enrolled patients experienced a significant improvement in total cholesterol (-13.6 %), LDL-C (-18.2 %), non-HDL-C (-15 %), glutamic oxaloacetic transaminase (-10 %), glutamate-pyruvate transaminase (-30.9 %), and hs-CRP (-18.2 %) versus placebo. No changes have been observed in the other investigated parameters in both groups. CONCLUSIONS: The tested combination of nutraceuticals has shown clinical efficacy in the reduction of total cholesterol, non-HDL, LDL and triglycerides, while improving the level of liver transaminases and high sensitivity C-reactive protein. Further confirmation are needed to verify these observations on the middle and long term with a larger number of subjects.
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In the same trial, non-HDL-C improved by −15% versus placebo.
“After the active treatment, there was a significant improvement in LDL-C (− 18.2%), non-HDL-C (− 15%), glutamic oxaloacetic transaminase (− 10%), glutamate-pyruvate transaminase (− 30.9%), and hs-CRP (− 18.2%) versus placebo [99].”
From Nutraceuticals in the Management of Dyslipidemia: Which, When, and for Whom? Could Nutraceuticals Help Low-Risk Individuals with Non-optimal Lipid Levels? (2021) · cites this paper as [99]
In the same trial, glutamate-pyruvate transaminase improved by −30.9% versus placebo.
“After the active treatment, there was a significant improvement in LDL-C (− 18.2%), non-HDL-C (− 15%), glutamic oxaloacetic transaminase (− 10%), glutamate-pyruvate transaminase (− 30.9%), and hs-CRP (− 18.2%) versus placebo [99].”
From Nutraceuticals in the Management of Dyslipidemia: Which, When, and for Whom? Could Nutraceuticals Help Low-Risk Individuals with Non-optimal Lipid Levels? (2021) · cites this paper as [99]
In a double-blind, placebo-controlled, cross-over trial of 30 adults with suboptimal LDL-C levels in primary prevention of CVD, active treatment with RYR (200 mg, monacolin K 10 mg), artichoke extract (500 mg), and banaba extract (50 mg) significantly improved LDL-C by −18.2% versus placebo.
“After the active treatment, there was a significant improvement in LDL-C (− 18.2%), non-HDL-C (− 15%), glutamic oxaloacetic transaminase (− 10%), glutamate-pyruvate transaminase (− 30.9%), and hs-CRP (− 18.2%) versus placebo [99].”
From Nutraceuticals in the Management of Dyslipidemia: Which, When, and for Whom? Could Nutraceuticals Help Low-Risk Individuals with Non-optimal Lipid Levels? (2021) · cites this paper as [99]
In the same trial, glutamic oxaloacetic transaminase improved by −10% versus placebo.
“After the active treatment, there was a significant improvement in LDL-C (− 18.2%), non-HDL-C (− 15%), glutamic oxaloacetic transaminase (− 10%), glutamate-pyruvate transaminase (− 30.9%), and hs-CRP (− 18.2%) versus placebo [99].”
From Nutraceuticals in the Management of Dyslipidemia: Which, When, and for Whom? Could Nutraceuticals Help Low-Risk Individuals with Non-optimal Lipid Levels? (2021) · cites this paper as [99]
In the same trial, hs-CRP improved by −18.2% versus placebo.
“After the active treatment, there was a significant improvement in LDL-C (− 18.2%), non-HDL-C (− 15%), glutamic oxaloacetic transaminase (− 10%), glutamate-pyruvate transaminase (− 30.9%), and hs-CRP (− 18.2%) versus placebo [99].”
From Nutraceuticals in the Management of Dyslipidemia: Which, When, and for Whom? Could Nutraceuticals Help Low-Risk Individuals with Non-optimal Lipid Levels? (2021) · cites this paper as [99]
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Cicero, A. F. G., Colletti, A., Bajraktari, G., Descamps, O., Djuric, D. M., Ezhov, M., Fras, Z., Katsiki, N., Langlois, M., Latkovskis, G., et al. (2017) · Archives of Medical Science · doi:10.5114/aoms.2017.69326 · Cited by 281 · see citing works
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Self-citationLipid-lowering activity of artichoke extracts: A systematic review and meta-analysis
Sahebkar, A., Pirro, M., Banach, M., Mikhailidis, D. P., Atkin, S. L., & Cicero, A. F. G. (2018) · Critical Reviews in Food Science and Nutrition · doi:10.1080/10408398.2017.1332572 · Cited by 86 · see citing works
Self-citation
- Authors
- Cicero, A. F. G., Colletti, A., Fogacci, F., Bove, M., Rosticci, M., & Borghi, C.
- Affiliations
- University of Bologna (IT)
- Corresponding author
- Cicero, Arrigo Francesco Giuseppe
- Venue
- High Blood Pressure & Cardiovascular Prevention
- Published
- 2016-06-23
- Volume
- 24
- Issue
- 1
- Pages
- 13-18
- ISSN
- 1120-9879 (ISSN-L)
- 1179-1985
- PMC
- PMC5315731
- OpenAlex
- W2472211112
- Cited by
- 35
- References
- 34
- Citations by year
- 2026: 2 · 2025: 2 · 2024: 3 · 2023: 2 · 2022: 2 · 2021: 4 · 2020: 5 · 2019: 6 · 2018: 4 · 2017: 4
- FWCI
- 5.17
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- High Blood Pressure & Cardiovascular Prevention (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion)
- Funders
- Università di Bologna (IT) (RFO2015)
- Topics
- Health Sciences › Medicine › Surgery › Natural Products and Biological Research
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Coenzyme Q10 studies and effects
- Keywords
- nutraceuticals, hypercholesterolemia, LDL cholesterol, artichoke, red yeast rice, Banaba, coenzyme Q10, lipid metabolism, glucose metabolism, insulin resistance, liver transaminases, C-reactive protein, inflammation, cardiovascular disease prevention, dietary habits
- MeSH terms
- Anti-Inflammatory Agents, Hypolipidemic Agents, Blood Glucose, Cardiovascular Diseases, Double-Blind Method, Drug Combinations, Female, Humans, Hypercholesterolemia, Hypoglycemic Agents, Italy, Lipids, Male, Middle Aged, Risk Factors, Severity of Illness Index, Time Factors, Biomarkers, Treatment Outcome, Cross-Over Studies, Inflammation Mediators, Dietary Supplements
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