Efficacy and Safety of Armolipid Plus®: An Updated PRISMA Compliant Systematic Review and Meta-Analysis of Randomized Controlled Clinical Trials
Open accessAbstract
Armolipid Plus® is a multi-constituent nutraceutical that claims to improve lipid profiles. The aim of this PRISMA compliant systematic review and meta-analysis was to globally evaluate the efficacy and safety of Armolipid Plus® on the basis of the available randomized, blinded, controlled clinical trials (RCTs). A systematic literature search in several databases was conducted in order to identify RCTs assessing the efficacy and safety of dietary supplementation with Armolipid Plus®. Two review authors independently identified 12 eligible studies (1050 included subjects overall) and extracted data on study characteristics, methods, and outcomes. Meta-analysis of the data suggested that dietary supplementation with Armolipid Plus® exerted a significant effect on body mass index (mean difference (MD) = −0.25 kg/m2, p = 0.008) and serum levels of total cholesterol (MD = −25.07 mg/dL, p < 0.001), triglycerides (MD = −11.47 mg/dL, p < 0.001), high-density lipoprotein cholesterol (MD = 1.84 mg/dL, p < 0.001), low-density lipoprotein cholesterol (MD = −26.67 mg/dL, p < 0.001), high sensitivity C reactive protein (hs-CRP, MD = −0.61 mg/L, p = 0.022), and fasting glucose (MD = −3.52 mg/dL, p < 0.001). Armolipid Plus® was well tolerated. This meta-analysis demonstrates that dietary supplementation with Armolipid Plus® is associated with clinically meaningful improvements in serum lipids, glucose, and hs-CRP. These changes are consistent with improved cardiometabolic health.
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Prior reviews of berberine have limitations including that they included studies that did not make comparisons to placebo, compared berberine to diverse controls, assessed extracts from the barberry plant, or defined the intervention as combination nutraceutical products containing berberine.
“Prior reviews of berberine have several limitations as they included studies that did not make comparisons to placebo, compared berberine to diverse controls (e.g., statins, oral hypoglycemics, lifestyle modification), assessed extracts from the barberry plant or defined the intervention as combination nutraceutical products containing berberine such as Armolipid Plus®.(7-13)”
From Overall and sex-specific effect of berberine for dyslipidemia: systematic review and meta-analysis of placebo-controlled trials (2022) · cites this paper as [12]
A meta-analysis of 12 randomized double-blind placebo-controlled clinical trials suggests that dietary supplementation with red yeast rice (3 mg MonK), policosanols (10 mg), and berberine (500 mg) exerts significant effects on BMI, LDL-C, TG, HDL-C, hs-CRP, and fasting glucose.
“A recent meta-analysis of 12 randomized double-blind placebo-controlled clinical trials including 1050 subjects suggested that dietary supplementation with this nutraceutical combination exerts a significant effect on body mass index (mean difference (MD) = − 0.25 kg/m2, p = 0.008) and serum levels of LDL-C (MD = − 26.67 mg/dL, p < 0.001), TG (MD = − 11.47 mg/dL, p < 0.001), HDL-C (MD = 1.84 mg/dL”
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 [93]
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References 64 · Cited by 20
Research works printed but not linked: 1
- [16]Higgins J. Green S. Cochrane Handbook for Systematic Reviews of Interventions Report Version 5.0.2.2009 John Wiley and Sons Ltd. Chichester, UK 2010
- Authors
- Cicero, A. F. G., Kennedy, C., Knežević, T., Bove, M., Georges, C. M. G., Šatrauskienė, A., Toth, P. P., & Fogacci, F.
- Affiliations
- IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola (IT)
- Trinity College Dublin (IE)
- University Hospital Centre Zagreb (HR)
- Cliniques Universitaires Saint-Luc (BE)
- Vilnius University (LT)
- Johns Hopkins University (US)
- Corresponding author
- Cicero, Arrigo F. G.
- ORCID
- Venue
- Nutrients
- Publisher
- MDPI AG
- Published
- 2021-02-16
- Volume
- 13
- Issue
- 2
- Pages
- 638
- ISSN
- 2072-6643 (ISSN-L)
- PMC
- PMC7920267
- OpenAlex
- W3129578081
- Cited by
- 20
- References
- 64
- Citations by year
- 2026: 1 · 2024: 2 · 2023: 7 · 2022: 6 · 2021: 4
- FWCI
- 1.14
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Nutrients (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion, cc-by)
- Digital Access to Libraries (submittedVersion, other-oa)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Topics
- Health Sciences › Medicine › Surgery › Natural Products and Biological Research
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Keywords
- nutraceuticals, dietary supplementation, lipid profile, serum cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, C-reactive protein, fasting blood glucose, body mass index, cardiometabolic health, safety
- MeSH terms
- Humans, Lipids, Body Mass Index, Randomized Controlled Trials as Topic, Dietary Supplements, Lipid Metabolism
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