Three‐arm, placebo‐controlled, randomized clinical trial evaluating the metabolic effect of a combined nutraceutical containing a bergamot standardized flavonoid extract in dyslipidemic overweight subjects
Abstract
Our double‐blind, placebo‐controlled, parallel‐group, dose‐escalation, clinical trial aimed to test the effect of a combined nutraceutical containing bergamot extract (120‐mg flavonoids), phytosterols, vitamin C, and chlorogenic acid from dry artichoke extract on 90 overweight dyslipidemic subjects. Participants were randomly allocated to treatment with two pills of either active treatment or placebo, or a combination of both (a pill per treatment). After 8 weeks, all active‐treated groups experienced a significant improvement in triglycerides (TG) versus placebo and in low‐density lipoprotein cholesterol (LDL‐C) versus baseline and placebo treatments. In the high‐dose‐treated group, also total cholesterol (TC), nonhigh‐density lipoprotein cholesterol (non‐HDL‐C), γ‐glutamil transpeptidasi, high‐sensitivity C‐reactive protein (hs‐CRP), and tumor necrosis factor‐α (TNF‐α) significantly decreased. At 24‐week follow‐up, TG levels maintained lower than baseline in all groups. All patients allocated to either low‐dose or high‐dose active treatment experienced a significant decrease in TG, LDL‐C, and homeostatin model assessment of insulin resistance. In subjects taking high‐dose active treatment, adiponectin significantly increased, whereas TC, non‐HDL‐C, insulin (fasting plasma insulin), leptin, leptin/adiponectin ratio, hs‐CRP, and TNF‐α were significantly reduced. The tested nutraceutical showed to improve lipid and glucose metabolism, adipokines pattern, and systemic inflammation in dyslipidemic overweight subjects.
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Bergamot-derived polyphenols (500 to 1500 mg/day) reduce LDL-C, triglycerides, non-HDL-C, malonyl dialdehyde, fasting plasma insulin, leptin, leptin/adiponectin ratio, hs-CRP, and TNF-α in a dose-dependent manner.
“bergamot-derived polyphenols (500 to 1500 mg/day) are able to reduce LDL-C, triglycerides, non-HDL-C, malonyl dialdehyde [52], fasting plasma insulin, leptin, leptin/adiponectin ratio, hs-CRP, and tumor necrosis factor alpha (TNF-α) [53], in a dose-dependent manner”
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 [53]
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- Authors
- Cicero, A. F. G., Fogacci, F., Bove, M., Giovannini, M., & Borghi, C.
- Affiliations
- University of Bologna (IT)
- Corresponding author
- Cicero, Arrigo Francesco Giuseppe
- Venue
- Phytotherapy Research
- Publisher
- Wiley
- Published
- 2019-06-21
- Volume
- 33
- Issue
- 8
- Pages
- 2094-2101
- ISSN
- 0951-418X (ISSN-L)
- 1099-1573
- OpenAlex
- W2953094892
- Cited by
- 51
- References
- 28
- Citations by year
- 2026: 2 · 2025: 7 · 2024: 11 · 2023: 5 · 2022: 10 · 2021: 9 · 2020: 7
- FWCI
- 6.20
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Phytotherapy Research (publishedVersion)
- PubMed (publishedVersion)
- Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion)
- Funders
- Università di Bologna
- Topics
- Health Sciences › Medicine › Surgery › Natural Products and Biological Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Natural Antidiabetic Agents Studies
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Keywords
- nutraceuticals, phytosterols, chlorogenic acid, artichoke extract, dyslipidemia, overweight, triglycerides, LDL cholesterol, total cholesterol, non-HDL cholesterol, insulin resistance, adiponectin, leptin, adipokines, systemic inflammation, C-reactive protein, TNF-α, gamma-glutamyl transferase, vitamin C, lipid metabolism, glucose metabolism
- MeSH terms
- Adult, Aged, Double-Blind Method, Female, Flavonoids, Humans, Male, Middle Aged, Plant Extracts, Plant Oils, Dietary Supplements, Dyslipidemias, Overweight, Young Adult
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