Antihypertensive Effects of an Optimized Aged Garlic Extract in Subjects with Grade I Hypertension and Antihypertensive Drug Therapy: A Randomized, Triple-Blind Controlled Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Experimental Design
2.2. Intervention
2.3. Study Population
2.4. Sample Size Determination
2.5. Outcomes
2.5.1. Blood Pressure
2.5.2. Endothelial Function
2.5.3. Nitric Oxide
2.5.4. Antioxidant Capacity
2.5.5. Inflammatory Cytokines
2.5.6. Angiotensin-Converting Enzyme (ACE) Activity
2.5.7. Statistical Analysis
3. Results
3.1. Study Design
3.2. Compliance and Reported Adverse Events
3.3. Blood Pressure, Endothelial Function, and Related Variables
3.4. Confounding Variables 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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Group A Placebo (mg per Tablet) | Group L ABG Extract (mg per Tablet) | |
---|---|---|
ABG extract | - | 250 |
Maltodextrin | 250 | - |
Microcrystalline cellulose | 90 | 90 |
Dicalcic phosphate | 157 | 157 |
Sodium croscarmellose | 10 | 10 |
Magnesium stearate | 7 | 7 |
Sodium Alginate | 3.06 | 3.06 |
Stearic acid | 0.03 | 0.03 |
Oleic acid | 1.54 | 1.54 |
Medium-chain triglycerides | 2.80 | 2.80 |
Ethylcellulose | 13.17 | 13.17 |
Hydroxypropyl methylcellulose | 4.86 | 4.86 |
Hydroxypropyl cellulose | 4.86 | 4.86 |
Talc | 2.88 | 2.88 |
Titanium oxide | 1.80 | 1.80 |
Garlic flavor | 1.00 | 1.00 |
Group A (Placebo) | Group L (ABG Extract) | p-Value | |
---|---|---|---|
No. of volunteers | 38 | 39 | |
Gender | Male: 20; Female: 18 | Male: 20; Female 19 | 0.9057 |
Age (years) | 64.1 ± 5.9 | 63.7 ± 5.8 | 0.8018 |
Systolic blood pressure (mmHg) | 145.5 ± 17.2 | 148.8 ± 22.9 | 0.4876 |
Diastolic blood pressure (mmHg) | 85.3 ± 10.8 | 85.7 ± 11.2 | 0.8765 |
Pulse pressure (mmHg) | 60.0 ± 12.9 | 62.7 ± 15.7 | 0.4300 |
Years of diagnosis | 15.4 ± 8.5 | 14.8 ± 11.2 | 0.8192 |
Antihypertensive drug number | |||
1 type | 13 | 13 | 0.6219 |
Two types | 13 | 10 | |
Three or more types | 12 | 16 | |
Antihypertensive drug type | |||
Thiazides | 25 | 27 | 0.9811 |
β-blockers | 11 | 14 | |
Angiotensin II receptor blocker | 15 | 16 | |
Calcium channel blockers | 14 | 17 | |
Other types of drugs | |||
Statins | 15 | 17 | 0.7826 |
Benzodiazepines | 10 | 9 | |
Anticoagulants | 8 | 10 | |
Proton pump inhibitors | 12 | 8 | |
Nonsteroidal anti-inflammatory drug | 14 | 10 | |
Antidiabetic | 2 | 4 | |
Treatment adherence | 96.7 ± 4.7 | 97.8 ± 6.8 | 0.4396 |
Minimum | 85% | 72% | |
Maximum | 108% | 112% | |
Treatment blinding | |||
Yes/No | 17/21 | 9/30 | 0.0559 |
Group A (Placebo) (n = 38) | Group L (ABG Extract) (n = 39) | ||||||
---|---|---|---|---|---|---|---|
Basal | 12 Weeks | Sidak’s p-Value | Basal | 12 Weeks | Sidak’s p-Value | Two-Way ANOVA p-Value | |
Blood pressure (office) | |||||||
Systolic (mmHg) | 144 ± 13 | 138 ± 14 | 0.0169 | 146 ± 21 | 143 ± 18 | 0.3011 | 0.3011 |
Diastolic (mmHg) | 85 ± 7 | 83 ± 10 | 0.2497 | 85 ± 10 | 83 ± 9 | 0.2889 | 0.9219 |
Pulse pressure (mmHg) | 59 ± 12 | 55 ± 14 | 0.0632 | 61 ± 16 | 60 ± 14 | 0.6126 | 0.2011 |
Endothelial function | |||||||
RHI | 2.059 ± 0.414 | 2.033 ± 0.597 | 0.9583 | 2.016 ± 0.569 | 2.068 ± 0.728 | 0.8276 | 0.9753 |
AI75 | 30.4 ± 14.9 | 26.7 ± 17.2 | 0.1767 | 25.0 ± 17.0 | 21.1 ± 15.1 | 0.1139 | 0.1185 |
Blood lipid profile | |||||||
Total cholesterol (mg/dL) | 188 ± 43 | 188 ± 43 | >0.9999 | 209 ± 40 | 209 ± 39 | 0.9984 | 0.9759 |
Triacylglycerides (mg/dL) | 107 ± 53 | 107 ± 55 | 0.9986 | 122 ± 53 | 117 ± 43 | 0.8725 | 0.1394 |
HDL-cholesterol (mg/dL) | 58 ± 15 | 58 ± 15 | 0.9939 | 59 ± 17 | 61 ± 21 | 0.8892 | 0.4172 |
Inflammatory cytokines | |||||||
IL-2 (pg/mL) | 0.190 ± 0.657 | 0.223 ± 0.790 | 0.9021 | 0.894 ± 1.844 | 1.022 ± 2.043 | 0.2236 | 0.0282 |
IL-4 (pg/mL) | 113 ± 541 | 121 ± 566 | 0.4704 | 213 ± 708 | 215 ± 705 | 0.9556 | 0.5079 |
IL-5 (pg/mL) | 3.8 ± 10.5 | 3.6 ± 10.4 | 0.8234 | 6.4 ± 16.1 | 6.5 ± 16.0 | 0.9021 | 0.3859 |
IL-8 (pg/mL) | 20.0 ± 29.8 | 21.6 ± 33.7 | 0.2054 | 25.0 ± 31.6 | 26.7 ± 33.0 | 0.2018 | 0.4948 |
IP-10 (pg/mL) | 490 ± 252 | 446 ± 231 | 0.3753 | 450 ± 202 | 539 ± 332 | 0.0218 | 0.6238 |
sCD40L (pg/mL) | 3856 ± 3927 | 2322 ± 2512 | 0.0543 | 3742 ± 3001 | 3211 ± 3337 | 0.6710 | 0.4978 |
Other variables | |||||||
Nitric oxide (µM) | 88 ± 23 | 90 ± 27 | 0.9188 | 87 ± 19 | 97 ± 31 | 0.0254 | 0.5101 |
ACE activity (U/L) | 78 ± 44 | 71 ± 41 | 0.1495 | 78 ± 40 | 69 ± 38 | 0.0398 | 0.9560 |
Uric acid (mg/dL) | 5.6 ± 1.4 | 5.6 ± 1.3 | 0.9987 | 6.0 ± 1.4 | 5.7 ± 1.3 | 0.0483 | 0.3986 |
FRAP (µM TE/min) | 0.111 ± 0.034 | 0.113 ± 0.029 | 0.6479 | 0.105 ± 0.036 | 0.113 ± 0.043 | 0.0161 | 0.6972 |
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Serrano, J.C.E.; Castro-Boqué, E.; García-Carrasco, A.; Morán-Valero, M.I.; González-Hedström, D.; Bermúdez-López, M.; Valdivielso, J.M.; Espinel, A.E.; Portero-Otín, M. Antihypertensive Effects of an Optimized Aged Garlic Extract in Subjects with Grade I Hypertension and Antihypertensive Drug Therapy: A Randomized, Triple-Blind Controlled Trial. Nutrients 2023, 15, 3691. https://doi.org/10.3390/nu15173691
Serrano JCE, Castro-Boqué E, García-Carrasco A, Morán-Valero MI, González-Hedström D, Bermúdez-López M, Valdivielso JM, Espinel AE, Portero-Otín M. Antihypertensive Effects of an Optimized Aged Garlic Extract in Subjects with Grade I Hypertension and Antihypertensive Drug Therapy: A Randomized, Triple-Blind Controlled Trial. Nutrients. 2023; 15(17):3691. https://doi.org/10.3390/nu15173691
Chicago/Turabian StyleSerrano, José C. E., Eva Castro-Boqué, Alicia García-Carrasco, María Inés Morán-Valero, Daniel González-Hedström, Marcelino Bermúdez-López, José Manuel Valdivielso, Alberto E. Espinel, and Manuel Portero-Otín. 2023. "Antihypertensive Effects of an Optimized Aged Garlic Extract in Subjects with Grade I Hypertension and Antihypertensive Drug Therapy: A Randomized, Triple-Blind Controlled Trial" Nutrients 15, no. 17: 3691. https://doi.org/10.3390/nu15173691
APA StyleSerrano, J. C. E., Castro-Boqué, E., García-Carrasco, A., Morán-Valero, M. I., González-Hedström, D., Bermúdez-López, M., Valdivielso, J. M., Espinel, A. E., & Portero-Otín, M. (2023). Antihypertensive Effects of an Optimized Aged Garlic Extract in Subjects with Grade I Hypertension and Antihypertensive Drug Therapy: A Randomized, Triple-Blind Controlled Trial. Nutrients, 15(17), 3691. https://doi.org/10.3390/nu15173691