Efficacy of Food Supplement Based on Monacolins, γ-Oryzanol, and γ-Aminobutyric Acid in Mild Dyslipidemia: A Randomized, Double-Blind, Parallel-Armed, Placebo-Controlled Clinical Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Food Supplement and Placebo
2.2. Study Design
2.3. Participants and Recruiting
2.4. Study Outcomes
2.5. Safety and Tolerability
2.6. Statistical Analysis
3. Results
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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Characteristic | Placebo Group (n = 44) | Food Supplement Group (n = 44) |
---|---|---|
Age (years) | 57 ± 7 | 53 ± 5 |
Sex: | ||
Females | 26 | 20 |
Males | 18 | 24 |
Ethnicity: Caucasian | 44 | 44 |
BMI (kg/m2): | ||
Females | 23.33 ± 3.56 | 23.30 ± 3.07 |
males | 23.42 ± 3.84 | 24.08 ± 3.63 |
Waist circumference (cm) | ||
females | 99.46 ± 6.15 | 97.85 ± 5.47 |
males | 99.50 ± 4.59 | 97.66 ± 4.91 |
Variable | Placebo Group | Food Supplement Group | ||
---|---|---|---|---|
t0 | t1 | t0 | t1 | |
FBG | 87.3 ± 10.4 | 87.9 ± 9.3 | 88.0 ± 10.2 | 86.8 ± 9.1 |
(70–104) | (70–105) | (71–105) | (71–104) | |
HbA1c | 5.0 ± 0.8 | 5.0 ± 0.9 | 5.1 ± 0.8 | 5.0 ± 0.9 |
(4–6) | (4–6) | (4–6) | (4–6) | |
TC | 217.5 ± 10.7 | 229.6 ± 12.7 | 222.7 ± 9.4 | 204.3 ± 11.3 |
(201–239) | (210–250) | (202–238) | (184–224) | |
HDL-C | 56.2 ± 14.6 | 51.8 ± 11.5 | 51.6 ± 13.1 | 66.7 ± 18.6 |
(30–80) | (30–70) | (30–103) | (36–130) | |
LDL-C | 101.6 ± 31.0 | 122.4 ± 27.4 | 115.7 ± 28.5 | 93.4 ± 23.8 |
(56–159) | (72–163) | (57–165) | (55–140) | |
TG | 98.6 ± 37.5 | 112.9 ± 38.0 | 100.4 ± 36.3 | 97.3 ± 25.9 |
(40–165) | (62–177) | (40–163) | (42–152) | |
ESR | 7.9 ± 4.2 | 9.1 ± 3.8 | 7.9 ± 3.7 | 8.8 ± 3.6 |
(2–15) | (2–15) | (2–14) | (2–15) | |
CRP | 4.3 ± 1.8 | 4.6 ± 1.9 | 4.5 ± 1.6 | 4.2 ± 1.7 |
(2–7) | (2–7) | (2–7) | (2–7) | |
WBCs | 7.5 ± 2.4 | 7.2 ± 2.3 | 7.0 ± 2.4 | 7.0 ± 2.4 |
(4–11) | (4–11) | (4–11) | (4–11) | |
AST | 19.6 ± 9.4 | 18.5 ± 8.9 | 21.5 ± 9.5 | 20.4 ± 8.5 |
(5–35) | (6–37) | (6–37) | (6–37) | |
ALT | 23.8 ± 11.7 | 28.2 ± 11.9 | 29.4 ± 11 | 24.8 ± 11.3 |
(4–44) | (5–45) | (9–45) | (5–45) | |
CRE | 1.1 ± 0.1 | 1.1 ± 0.1 | 1.1 ± 0.1 | 1.1 ± 0.1 |
(0.91–1.28) | (0.9–1.3) | (0.9–1.3) | (0.9–1.29) |
Variable | F-Value | DF | p |
---|---|---|---|
TC | |||
Measure | 3.162 | 1.88 | 0.08 |
Group | 38.899 | 1.83 | <0.001 |
Sex | 5.169 | 1.82 | 0.026 |
Age | 0.114 | 1.82 | 0.74 |
BMI | 0.002 | 1.90 | 0.97 |
Waist circumference | 0.955 | 1.99 | 0.33 |
Measure × group | 85.597 | 1.87 | <0.001 |
HDL-C | |||
Measure | 5.809 | 1.88 | 0.018 |
Group | 5.144 | 1.83 | 0.026 |
Sex | 0.915 | 1.82 | 0.34 |
Age | 0.174 | 1.83 | 0.68 |
BMI | 0.146 | 1.90 | 0.70 |
Waist circumference | 0.000 | 1.99 | 0.99 |
Measure × group | 18.866 | 1.88 | <0.001 |
LDL-C | |||
Measure | 0.144 | 1.88 | 0.71 |
Group | 2.059 | 1.83 | 0.16 |
Sex | 0.006 | 1.82 | 0.94 |
Age | 1.270 | 1.83 | 0.26 |
BMI | 0.157 | 1.92 | 0.69 |
Waist circumference | 2.935 | 1.102 | 0.09 |
Measure × group | 27.617 | 1.88 | <0.001 |
TG | |||
Measure | 1.589 | 1.168 | 0.21 |
Group | 3.865 | 1.168 | 0.051 |
Sex | 1.261 | 1.168 | 0.26 |
Age | 1.995 | 1.168 | 0.16 |
BMI | 0.275 | 1.168 | 0.60 |
Waist circumference | 3.282 | 1.168 | 0.07 |
Measure × group | 3.166 | 1.168 | 0.08 |
Variable | F | Gdl | p |
FBG | |||
Measure | 0.097 | 1.88 | 0.76 |
Group | 0.002 | 1.83 | 0.97 |
Sex | 0.001 | 1.82 | 0.97 |
Age | 0.067 | 1.82 | 0.80 |
BMI | 0.081 | 1.92 | 0.78 |
Waist circumference | 0.312 | 1.103 | 0.58 |
Measure × group | 0.378 | 1.87 | 0.54 |
HbA1c | |||
Measure | 0.129 | 1.87 | 0.72 |
Group | 0.549 | 1.83 | 0.46 |
Sex | 0.618 | 1.82 | 0.43 |
Age | 0.130 | 1.82 | 0.72 |
BMI | 0.731 | 1.90 | 0.39 |
Waist circumference | 0.024 | 1.99 | 0.88 |
Measure × group | 0.004 | 1.87 | 0.95 |
CRP | |||
Measure | 0.010 | 1.88 | 0.92 |
Group | 0.000 | 1.83 | 0.99 |
Sex | 0.350 | 1.82 | 0.56 |
Age | 0.080 | 1.82 | 0.78 |
BMI | 0.037 | 1.91 | 0.85 |
Waist circumference | 0.972 | 1.101 | 0.33 |
Measure × group | 1.449 | 1.87 | 0.23 |
WBCs | |||
Measure | 0.266 | 1.168 | 0.61 |
Group | 1.072 | 1.168 | 0.30 |
Sex | 0.317 | 1.168 | 0.57 |
Age | 0.043 | 1.168 | 0.84 |
BMI | 0.949 | 1.168 | 0.33 |
Waist circumference | 0.180 | 1.168 | 0.67 |
Measure × group | 0.296 | 1.168 | 0.59 |
ESR | |||
Measure | 3.688 | 1.168 | 0.06 |
Group | 0.425 | 1.168 | 0.52 |
Sex | 0.002 | 1.168 | 0.97 |
Age | 0.002 | 1.168 | 0.96 |
BMI | 5.060 | 1.168 | 0.026 |
Waist circumference | 1.652 | 1.168 | 0.20 |
Measure × group | 0.201 | 1.168 | 0.65 |
Variable | F | Gdl | p |
---|---|---|---|
AST | |||
Measure | 0.460 | 1.168 | 0.50 |
Group | 0.913 | 1.168 | 0.34 |
Sex | 0.961 | 1.168 | 0.33 |
Age | 0.012 | 1.168 | 0.91 |
BMI | 0.003 | 1.168 | 0.96 |
Waist circumference | 0.981 | 1.168 | 0.32 |
Measure × group | 0.000 | 1.168 | 0.98 |
ALT | |||
Measure | 0.010 | 1.168 | 0.92 |
Group | 0.151 | 1.168 | 0.70 |
Sex | 4.165 | 1.168 | 0.043 |
Age | 0.085 | 1.168 | 0.77 |
BMI | 0.012 | 1.168 | 0.91 |
Waist circumference | 0.165 | 1.168 | 0.68 |
Measure × group | 6.546 | 1.168 | 0.011 |
CRE | |||
Measure | 0.104 | 1.168 | 0.75 |
Group | 0.810 | 1.168 | 0.37 |
Sex | 0.599 | 1.168 | 0.44 |
Age | 0.270 | 1.168 | 0.60 |
BMI | 0.138 | 1.168 | 0.71 |
Waist circumference | 0.862 | 1.168 | 0.35 |
Measure × group | 1.377 | 1.168 | 0.24 |
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De Lellis, L.F.; Morone, M.V.; Buccato, D.G.; Cordara, M.; Larsen, D.S.; Ullah, H.; Piccinocchi, R.; Piccinocchi, G.; Balaji, P.; Baldi, A.; et al. Efficacy of Food Supplement Based on Monacolins, γ-Oryzanol, and γ-Aminobutyric Acid in Mild Dyslipidemia: A Randomized, Double-Blind, Parallel-Armed, Placebo-Controlled Clinical Trial. Nutrients 2024, 16, 2983. https://doi.org/10.3390/nu16172983
De Lellis LF, Morone MV, Buccato DG, Cordara M, Larsen DS, Ullah H, Piccinocchi R, Piccinocchi G, Balaji P, Baldi A, et al. Efficacy of Food Supplement Based on Monacolins, γ-Oryzanol, and γ-Aminobutyric Acid in Mild Dyslipidemia: A Randomized, Double-Blind, Parallel-Armed, Placebo-Controlled Clinical Trial. Nutrients. 2024; 16(17):2983. https://doi.org/10.3390/nu16172983
Chicago/Turabian StyleDe Lellis, Lorenza Francesca, Maria Vittoria Morone, Daniele Giuseppe Buccato, Marcello Cordara, Danaè S. Larsen, Hammad Ullah, Roberto Piccinocchi, Gaetano Piccinocchi, Paulraj Balaji, Alessandra Baldi, and et al. 2024. "Efficacy of Food Supplement Based on Monacolins, γ-Oryzanol, and γ-Aminobutyric Acid in Mild Dyslipidemia: A Randomized, Double-Blind, Parallel-Armed, Placebo-Controlled Clinical Trial" Nutrients 16, no. 17: 2983. https://doi.org/10.3390/nu16172983