Effect of a New Formulation of Nutraceuticals as an Add-On to Metformin Monotherapy for Patients with Type 2 Diabetes and Suboptimal Glycemic Control: A Randomized Controlled Trial
The aim of the study was to evaluate the overall biohumoral and metabolic effects of a 12-week add-on therapy consisting of a new nutraceutical formulation (BHC) based on berberine, hesperidin, and chromium picolinate in type 2 diabetes mellitus (T2D) patients with suboptimal glycemic compensation r...
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doaj-6a3a1e644c4a4c72998a4f4f60ba541f2021-07-23T13:58:54ZengMDPI AGNutrients2072-66432021-07-01132373237310.3390/nu13072373Effect of a New Formulation of Nutraceuticals as an Add-On to Metformin Monotherapy for Patients with Type 2 Diabetes and Suboptimal Glycemic Control: A Randomized Controlled TrialGiovanni Sartore0Eugenio Ragazzi1Giulia Antonello2Chiara Cosma3Annunziata Lapolla4Department of Medicine-DIMED, University of Padova, I-35128 Padova, ItalyDepartment of Pharmaceutical and Pharmacological Sciences, University of Padova, I-35131 Padova, ItalyDepartment of Medicine-DIMED, University of Padova, I-35128 Padova, ItalyDepartment of Laboratory Medicine, University of Padova, I-35128 Padova, ItalyDepartment of Medicine-DIMED, University of Padova, I-35128 Padova, ItalyThe aim of the study was to evaluate the overall biohumoral and metabolic effects of a 12-week add-on therapy consisting of a new nutraceutical formulation (BHC) based on berberine, hesperidin, and chromium picolinate in type 2 diabetes mellitus (T2D) patients with suboptimal glycemic compensation receiving metformin. After 12 weeks, participants in the group receiving metformin plus BHC, compared to the group receiving metformin only, saw a significant improvement in their glucose profile, in terms of both glycated hemoglobin (HbA1c) and fasting blood glucose (FBG). Their FBG dropped from 145 ± 20 mg/dL to 128 ± 23 mg/dL (<i>p</i> < 0.01), a decrease of 11.7% compared with the baseline. This decrease differed significantly from the situation in the control arm (<i>p</i> < 0.05). HbA1c decreased by 7.5% from the baseline, from 53.5 ± 4.3 mmol/mol to 49.5 ± 5.1 mmol/mol (<i>p</i> < 0.01), in the group given BHC, while no difference was seen in the control group. Advanced glycation end products (AGEs) and malondialdehyde (MDA) were found to be significantly reduced (<i>p</i> < 0.01) only in the BHC group, from 9.34 ± 7.61 μg/mL to 6.75 ± 6.13 μg/mL, and from 1.7 ± 0.15 μmol/L to 1.4 ± 0.25 μmol/L, respectively. In patients with T2D taking metformin with suboptimal glycemic compensation, adding BHC for 3 months significantly improved glucose control in terms of FBG and HbA1c, and had a positive effect on the lipid peroxidation profile, as indicated by a decrease in AGEs and MDA.https://www.mdpi.com/2072-6643/13/7/2373advanced glycation end productsberberinehesperidinglyco-oxidation |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Giovanni Sartore Eugenio Ragazzi Giulia Antonello Chiara Cosma Annunziata Lapolla |
spellingShingle |
Giovanni Sartore Eugenio Ragazzi Giulia Antonello Chiara Cosma Annunziata Lapolla Effect of a New Formulation of Nutraceuticals as an Add-On to Metformin Monotherapy for Patients with Type 2 Diabetes and Suboptimal Glycemic Control: A Randomized Controlled Trial Nutrients advanced glycation end products berberine hesperidin glyco-oxidation |
author_facet |
Giovanni Sartore Eugenio Ragazzi Giulia Antonello Chiara Cosma Annunziata Lapolla |
author_sort |
Giovanni Sartore |
title |
Effect of a New Formulation of Nutraceuticals as an Add-On to Metformin Monotherapy for Patients with Type 2 Diabetes and Suboptimal Glycemic Control: A Randomized Controlled Trial |
title_short |
Effect of a New Formulation of Nutraceuticals as an Add-On to Metformin Monotherapy for Patients with Type 2 Diabetes and Suboptimal Glycemic Control: A Randomized Controlled Trial |
title_full |
Effect of a New Formulation of Nutraceuticals as an Add-On to Metformin Monotherapy for Patients with Type 2 Diabetes and Suboptimal Glycemic Control: A Randomized Controlled Trial |
title_fullStr |
Effect of a New Formulation of Nutraceuticals as an Add-On to Metformin Monotherapy for Patients with Type 2 Diabetes and Suboptimal Glycemic Control: A Randomized Controlled Trial |
title_full_unstemmed |
Effect of a New Formulation of Nutraceuticals as an Add-On to Metformin Monotherapy for Patients with Type 2 Diabetes and Suboptimal Glycemic Control: A Randomized Controlled Trial |
title_sort |
effect of a new formulation of nutraceuticals as an add-on to metformin monotherapy for patients with type 2 diabetes and suboptimal glycemic control: a randomized controlled trial |
publisher |
MDPI AG |
series |
Nutrients |
issn |
2072-6643 |
publishDate |
2021-07-01 |
description |
The aim of the study was to evaluate the overall biohumoral and metabolic effects of a 12-week add-on therapy consisting of a new nutraceutical formulation (BHC) based on berberine, hesperidin, and chromium picolinate in type 2 diabetes mellitus (T2D) patients with suboptimal glycemic compensation receiving metformin. After 12 weeks, participants in the group receiving metformin plus BHC, compared to the group receiving metformin only, saw a significant improvement in their glucose profile, in terms of both glycated hemoglobin (HbA1c) and fasting blood glucose (FBG). Their FBG dropped from 145 ± 20 mg/dL to 128 ± 23 mg/dL (<i>p</i> < 0.01), a decrease of 11.7% compared with the baseline. This decrease differed significantly from the situation in the control arm (<i>p</i> < 0.05). HbA1c decreased by 7.5% from the baseline, from 53.5 ± 4.3 mmol/mol to 49.5 ± 5.1 mmol/mol (<i>p</i> < 0.01), in the group given BHC, while no difference was seen in the control group. Advanced glycation end products (AGEs) and malondialdehyde (MDA) were found to be significantly reduced (<i>p</i> < 0.01) only in the BHC group, from 9.34 ± 7.61 μg/mL to 6.75 ± 6.13 μg/mL, and from 1.7 ± 0.15 μmol/L to 1.4 ± 0.25 μmol/L, respectively. In patients with T2D taking metformin with suboptimal glycemic compensation, adding BHC for 3 months significantly improved glucose control in terms of FBG and HbA1c, and had a positive effect on the lipid peroxidation profile, as indicated by a decrease in AGEs and MDA. |
topic |
advanced glycation end products berberine hesperidin glyco-oxidation |
url |
https://www.mdpi.com/2072-6643/13/7/2373 |
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