Effect of Dietary Supplementation with Eufortyn® Colesterolo Plus on Serum Lipids, Endothelial Reactivity, Indexes of Non-Alcoholic Fatty Liver Disease and Systemic Inflammation in Healthy Subjects with Polygenic Hypercholesterolemia: The ANEMONE Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design andParticipants
2.2. Treatment
2.3. Assessments
2.3.1. Clinical Data and Anthropometric Measurements
2.3.2. Laboratory Analyses
2.3.3. Blood Pressure Measurements
2.3.4. Endothelial Reactivity
2.3.5. Assessment of Safety and Tolerability
2.4. Statistical Analysis
3. Results
3.1. Efficacy Analysis
3.2. Safety Analysis
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Ingredients | Quantity per Tablet |
---|---|
Vazguard® (Phytosome Bergamot Polyphenolic fraction) | 1000 mg |
Pycrinil® artichoke d.e. (Cynara cardunculus L.) | 100 mg |
Artichoke d.e. (Cynara scolymus L.) | 20 mg |
Ubiqsome® (Coenzyme Q10 phytosome) | 25 mg |
equivalent to Coenzyme Q10 | 5 mg |
Zinc | 5 mg |
Parameters | Placebo (n. 28) | Eufortyn® Colesterolo Plus (n. 28) | ||
---|---|---|---|---|
Baseline | Week 8 | Baseline | Week 8 | |
Total energy (Kcal/day) | 1629 ± 110 | 1611 ± 105 | 1591 ± 99 | 1586 ± 116 |
Carbohydrates (% of total energy) | 54.4 ± 2.3 | 53.2 ± 2.5 | 54.5 ± 2.1 | 54.4 ± 2.4 |
Proteins (% of total energy) | 18.2 ± 1.4 | 18.4 ± 1.6 | 17.8 ± 1.5 | 18.1 ± 1.3 |
Animal protein (% of total energy) | 10.5 ± 0.9 | 9.9 ± 0.9 | 10.6 ± 0.7 | 10.9 ± 0.8 |
Vegetal protein (% of total energy) | 7.3 ± 0.6 | 7.5 ± 0.8 | 6.7 ± 0.6 | 6.8 ± 0.7 |
Total fats (% of total energy) | 27.7 ± 2.0 | 27.5 ± 2.3 | 27.2 ± 1.7 | 28.0 ± 2.1 |
Saturated fatty acids (% of total energy) | 8.0 ± 0.8 | 8.2 ± 0.7 | 8.3 ± 0.7 | 7.8 ± 0.9 |
MUFA (% of total energy) | 12.6 ± 1.1 | 12.2 ± 1.0 | 12.8 ± 1.0 | 12.3 ± 1.1 |
PUFA (% of total energy) | 6.7 ± 0.6 | 6.2 ± 0.7 | 6.5 ± 0.5 | 6.7 ± 0.6 |
Total dietary fibers (g/day) | 18.9 ± 2.5 | 19.1 ± 2.8 | 19.3 ± 2.5 | 18.7 ± 2.4 |
Cholesterol (mg/day) | 191.2 ± 13.3 | 187.2 ± 12.3 | 192.8 ± 11.5 | 194.8 ± 10.7 |
Parameters | Placebo (n. 28) | Eufortyn® Colesterolo Plus (n. 28) | ||
---|---|---|---|---|
Baseline | Week 8 | Baseline | Week 8 | |
Age (years) | 54 ± 3 | - | 54 ± 4 | - |
Body Mass Index (Kg/m2) | 24.3 ± 3.9 | 24.4 ± 3.7 | 23.9 ± 2.9 | 23.7 ± 2.7 |
Waist Circumference (cm) | 87.1 ± 14.0 | 87.1 ± 13.8 | 85.8 ± 12.4 | 84.8 ± 11.4 § |
SBP (mmHg) | 135.4 ± 16.1 | 131.6 ± 17.7 | 133.8 ± 16.5 | 130.9 ± 17.9 |
DBP (mmHg) | 73.5 ± 12.5 | 72.8 ± 10.3 | 73.8 ± 10.7 | 75.7 ± 12.8 |
Heart Rate (bpm) | 65.5 ± 11.2 | 69.1 ± 12.3 | 73.3 ± 13.3 § | 71.0 ± 13.0 |
Total Cholesterol (mg/dL) | 223.7 ± 24.7 | 227.7 ± 22.3 | 229.2 ± 20.8 | 214.5 ± 22.9 §,* |
LDL-C (mg/dL) | 141.9 ± 20.1 | 144.9 ± 20.2 | 143.3 ± 17.3 | 131.2 ± 19.8 §,* |
HDL-C (mg/dL) | 57.4 ± 17.6 | 56.5 ± 14.9 | 64.9 ± 18.9 § | 61.8 ± 18.0 |
Non-HDL-C (mg/dL) | 166.4 ± 23.6 | 159.5 ± 29.0 | 165.3 ± 20.1 | 158.7 ± 23.1 * |
LDL-C/HDL-C | 2.7 ± 0.8 | 2.7 ± 0.8 | 2.5 ± 0.8 | 2.4 ± 0.8 § |
Triglycerides (mg/dL) | 117.3 ± 70.2 | 126.3 ± 59.5 | 109.7 ± 54.3 | 112.9 ± 47.3 § |
Apolipoprotein B-100 (mg/dL) | 122.0 ± 16.2 | 126.2 ± 17.6 | 118.0 ± 14.6 | 121.4 ± 16.9 |
Apolipoprotein AI (mg/dL) | 154.2 ± 26.3 | 154.4 ± 24.2 | 160.4 ± 27.9 | 155.9 ± 28.8 |
FPG (mg/dL) | 90.1 ± 8.5 | 91.4 ± 7.1 | 88.2 ± 11.3 | 89.2 ± 10.5 |
AST (U/L) | 21.2 ± 7.2 | 21.2 ± 4.6 | 22.3 ± 4.6 | 22.8 ± 4.6 |
ALT (U/L) | 22.7 ± 14.4 | 20.6 ± 10.3 | 19.2 ± 6.9 § | 19.0 ± 6.9 |
gGT (U/L) | 25.2 ± 20.5 | 25.2 ± 17.9 | 21.9 ± 13.3 § | 22.4 ± 13.6 |
Lipid Accumulation Product | 34.9 ± 16.4 | 38.1 ± 19.1 | 33.4 ± 16.3 | 32.9 ± 13.3 § |
Hepatic Steatosis Index | 33.4 ± 5.2 | 32.8 ± 4.9 | 32.1 ± 4.1 | 31.7 ± 3.8 |
Fatty Liver Index | 31.4 ± 15.9 | 29.5 ± 17.6 | 26.4 ± 14.5 | 26.2 ± 13.9 § |
CPK (U/L) | 102.3 ± 74.8 | 108.4 ± 104.1 | 114.1 ± 67.8 | 99.2 ± 51.0 |
eGFR (mL/min) | 85.9 ± 15.8 | 85.9 ± 16.1 | 85.6 ± 15.9 | 83.0 ± 16.7 |
hs-CRP (mg/L) | 0.15 ± 0.15 | 0.12 ± 0.10 | 0.17 ± 0.24 | 0.13 ± 0.15 * |
Endothelial reactivity | 1.37 ± 0.31 | 1.38 ± 0.17 | 1.33 ± 0.27 | 1.43 ± 0.22 * |
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Fogacci, F.; Rizzoli, E.; Giovannini, M.; Bove, M.; D’Addato, S.; Borghi, C.; Cicero, A.F.G. Effect of Dietary Supplementation with Eufortyn® Colesterolo Plus on Serum Lipids, Endothelial Reactivity, Indexes of Non-Alcoholic Fatty Liver Disease and Systemic Inflammation in Healthy Subjects with Polygenic Hypercholesterolemia: The ANEMONE Study. Nutrients 2022, 14, 2099. https://doi.org/10.3390/nu14102099
Fogacci F, Rizzoli E, Giovannini M, Bove M, D’Addato S, Borghi C, Cicero AFG. Effect of Dietary Supplementation with Eufortyn® Colesterolo Plus on Serum Lipids, Endothelial Reactivity, Indexes of Non-Alcoholic Fatty Liver Disease and Systemic Inflammation in Healthy Subjects with Polygenic Hypercholesterolemia: The ANEMONE Study. Nutrients. 2022; 14(10):2099. https://doi.org/10.3390/nu14102099
Chicago/Turabian StyleFogacci, Federica, Elisabetta Rizzoli, Marina Giovannini, Marilisa Bove, Sergio D’Addato, Claudio Borghi, and Arrigo F. G. Cicero. 2022. "Effect of Dietary Supplementation with Eufortyn® Colesterolo Plus on Serum Lipids, Endothelial Reactivity, Indexes of Non-Alcoholic Fatty Liver Disease and Systemic Inflammation in Healthy Subjects with Polygenic Hypercholesterolemia: The ANEMONE Study" Nutrients 14, no. 10: 2099. https://doi.org/10.3390/nu14102099