Hypoglycemic and Hypolipemic Effects of a New Lecithin Formulation of Bergamot Polyphenolic Fraction : A Double Blind, Randomized, Placebo- Controlled Study

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OBJECTIVE: Hyperlipemia represents an independent risk factor in the development of atherosclerosis in patients undergoing type 2 diabetes mellitus (DM). Moreover, the pharmacological treatment of dyslipemia in patients undergoing type 2 DM (e.g. by means of statins), is accompanied by relevant side effects and oral supplementation with natural antioxidants, such as Citrus polyphenols, has recently been suggested to improve cardioprotection in such patients. However, due to the poor gastrointestinal absorption of polyphenols, novel formulations have recently been developed for getting a better bioavailability of polyphenolic rich fractions of citrus species extract rich in polyphenols.

METHODS: Here, we investigated the effect of standard bergamot polyphenolic fraction (BPF®) as well as of its phytosomal formulation (BPF Phyto), in patients with type 2 DM and hyperlipemia. A randomized, double blind, placebo-controlled study was carried out in 60 patients suffering from type 2 DM and mixed hyperlipemia. Patients were divided into three groups: one receiving placebo, the second receiving standard BPF and the third BPF Phyto.

RESULTS: In the groups receiving BPF and BPF Phyto, a significant reduction of fasting plasma glucose, serum LDL cholesterol and triglycerides accompanied by increased HDL cholesterol was observed. This effect was associated with significant reduction of small dense atherogenic LDL particles, as detected by means of proton NMR Spectroscopy, thus confirming the hypolipemic and hypoglycemic effect of bergamot extract both when using standard formulation as well as BPF Phyto. No differences were seen in the therapeutic response among groups receiving BPF and BPF Phyto, thus suggesting a substantial bioequivalence in their hypoglycemic and hypolipemic profile. However, when comparing the pharmacokinetic profile of naringin (the major component of BPF) and its metabolites, in patients treated with BPF Phyto, an at least 2,5 fold increase in its absorption was found, confirming in human studies the better profile of BPF Phyto compared to standard BPF.

CONCLUSION: These data suggest that better absorption and tissue distribution of BPF Phyto formulation represents an innovative approach in supplementation treatments of cardiometabolic disorders.

Medienart:

E-Artikel

Erscheinungsjahr:

2019

Erschienen:

2019

Enthalten in:

Zur Gesamtaufnahme - volume:19

Enthalten in:

Endocrine, metabolic & immune disorders drug targets - 19(2019), 2 vom: 28., Seite 136-143

Sprache:

Englisch

Beteiligte Personen:

Mollace, Vincenzo [VerfasserIn]
Scicchitano, Miriam [VerfasserIn]
Paone, Sara [VerfasserIn]
Casale, Francesca [VerfasserIn]
Calandruccio, Carla [VerfasserIn]
Gliozzi, Micaela [VerfasserIn]
Musolino, Vincenzo [VerfasserIn]
Carresi, Cristina [VerfasserIn]
Maiuolo, Jessica [VerfasserIn]
Nucera, Saverio [VerfasserIn]
Riva, Antonella [VerfasserIn]
Allegrini, Pietro [VerfasserIn]
Ronchi, Massimo [VerfasserIn]
Petrangolini, Giovanna [VerfasserIn]
Bombardelli, Ezio [VerfasserIn]

Links:

Volltext

Themen:

39W1PKE3JI
97C5T2UQ7J
BPF Phytosome
Bergamot oil
Bergamot polyphenolic fraction
Bioavailability
Cholesterol
Flavonoids
Hyperlipemia.
Hypoglycemic Agents
Hypolipidemic Agents
Journal Article
Lecithins
Placebos
Plant Extracts
Plant Oils
Polyphenols
Randomized Controlled Trial
Type 2 diabetes mellitus

Anmerkungen:

Date Completed 18.06.2019

Date Revised 18.06.2019

published: Print

Citation Status MEDLINE

doi:

10.2174/1871530319666181203151513

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM291324975