Carnosine Did Not Affect Vascular and Metabolic Outcomes in Patients with Prediabetes and Type 2 Diabetes: A 14-Week Randomized Controlled Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design and Participants
2.2. Ethics
2.3. Sample Size Calculation
2.4. Screening
2.5. Intervention and Random Assignment
2.6. Outcome Measures
2.6.1. Anthropometric Measurements
2.6.2. Blood Pressure
2.6.3. Lipid Profile
2.6.4. Liver Fibroscan
2.6.5. Liver Function Tests and Renal Outcomes
2.6.6. Endothelial Function
2.6.7. Arterial Stiffness and Central Pressure
2.6.8. International Physical Activity Questionnaire (IPAQ)
2.6.9. Record of Habitual Diet
2.7. Statistical Analysis
3. Results
3.1. Study Population and Baseline Characteristics
3.2. Effect of Carnosine Supplementation on Hepatorenal Outcomes
3.3. Effect of Carnosine Supplementation on Cardiovascular Outcomes
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 | Carnosine Group (n = 20) | Placebo Group (n = 23) |
---|---|---|
Age, year | 53.7 (48.5–59.4) a | 52 (42.3–59.3) |
Men, n (%) | 14 (70) | 16 (69.56) |
Caucasian | 11 (55) | 11 (47.82) |
South and Central Asian | 6 (30) | 6 (26.08) |
Southeast and Northeast Asian | 3 (15) | 5 (21.73) |
Other b | - | 1 (4.34) |
Total energy, kj | 7935.80 ± 1303.64 | 8206.88 ± 1319.38 |
Physical activity c, IPAQ-METS score d | 2400 (798–4878) | 1332 (390–2736) |
Weight, kg | 86.92 ± 21.22 | 82.02 ± 13.61 |
BMI, kg/m2 | 30.54 ± 4.74 | 28.29 ± 3.66 |
HOMA-IR | 2.88 ± 1.39 | 2.35 ± 1.08 |
HbA1c, % | 6.48 ± 0.63 | 6.65 ± 0.83 |
SBP, mmHg | 124.94 ± 12.97 | 122.62 ± 11.46 |
DBP, mmHg | 81.94 ± 8.59 | 80.71 ± 5.81 |
Family history of diabetes e, n (%) | 5 (25) | 4 (17.39) |
Patients with T2DM, n | 11 (55) | 17 (73.91) |
Dyslipidaemia, n | 2 (10) | 4 (17.39) |
Nephropathy, n | 2 (10) | 2 (8.69) |
Oral glucose-lowering agents, n | 7 (35) | 7 (30.43) |
Diet therapy, n | 5 (25) | 10 (43.47) |
No treatment, n | 8 (40) | 6 (26.08) |
Outcome Variable | Carnosine Group (n = 20) | Placebo Group (n = 23) | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Baseline | Follow-Up | p a | Change | Baseline | Follow-Up | p b | Change | p c | ||
Lipid profile | TG (mmol/L) | 1.66 ± 0.88 d | 1.58 ± 0.73 | >0.99 | −0.01 | 1.72 ± 0.67 | 1.86 ± 0.75 | >0.99 | 0.02 | 0.231 |
TC (mmol/L) | 5.36 ± 0.89 | 5.29 ± 0.71 | >0.99 | −0.003 | 5.30 ± 0.97 | 5.14 ± 0.85 | >0.99 | −0.01 | 0.428 | |
LDL-C (mmol/L) | 3.36 ± 0.6 | 3.42 ± 0.57 | >0.99 | 0.05 | 3.19 ± 0.6 | 3.04 ± 0.55 | >0.99 | −0.14 | 0.060 | |
HDL-C (mmol/L) | 1.13 ± 0.26 | 1.1 ± 0.23 | >0.99 | −0.03 | 1.19 ± 0.26 | 1.15 ± 0.26 | >0.99 | −0.03 | 0.810 | |
LDL-C/HDL-C | 3.1 ± 0.85 | 3.15 ± 0.79 | >0.99 | 0.11 | 2.81 ± 0.68 | 2.68 ± 0.75 | >0.99 | −0.13 | 0.100 | |
Hepatic outcomes | ALT (U/L) | 38.32 ± 18.64 | 36 ± 15.50 | >0.99 | −2.32 | 38.19 ± 16.34 | 34.33 ± 15.55 | 0.39 | −3.86 | 0.321 |
GGT (U/L) | 34.47 ± 13.35 | 34.53 ± 12.90 | >0.99 | 0.05 | 34.33 ± 12.57 | 32.57 ± 12.13 | >0.99 | −1.76 | 0.476 | |
ALP (U/L) | 82.63 ± 18.23 | 79.42 ± 16.13 | >0.99 | −3.21 | 79.57 ± 22.06 | 75.48 ± 18.35 | >0.99 | −4.10 | 0.569 | |
IQR | 33.17 ± 9.57 | 27.17 ± 11.28 | >0.99 | −6 | 34.53 ± 14.01 | 30.53 ± 11.39 | >0.99 | −4 | 0.470 | |
Median stiffness (KPa) | 5.66 ± 2.00 | 5.72 ± 1.59 | >0.99 | 0.01 | 5.13 ± 1.64 | 5.51 ± 1.24 | >0.99 | 0.04 | 0.826 | |
IQR to Median stiffness | 0.13 ± 0.06 | 0.15 ± 0.07 | >0.99 | 0.02 | 0.13 ± 0.06 | 0.13 ± 0.05 | >0.99 | 0.004 | 0.390 | |
CAP (dB/m) | 290.6 ± 72.21 | 301 ± 61.86 | >0.99 | 10.4 | 288.56 ± 61.04 | 293.78 ± 64.68 | >0.99 | 5.22 | 0.655 | |
Renal outcomes | Sodium (mmol/L) | 139 (137–140) e | 138 (137–139) | >0.99 | −0.21 | 138 (137–140) | 138.5 (137–140) | >0.99 | 0.09 | 0.521 |
Potassium (mmol/L) | 4.23 ± 0.26 | 4.16 ± 0.22 | >0.99 | −0.06 | 4.20 ± 0.25 | 4.19 ± 0.20 | >0.99 | −0.009 | 0.555 | |
Bicarbonate (mmol/L) | 25.63 ± 2.21 | 25.63 ± 2.40 | >0.99 | 0 | 25.91 ± 1.74 | 25.68 ± 2.12 | >0.99 | −0.23 | 0.763 | |
Urea (mmol/L) | 5.24 ± 0.87 | 5.43 ± 1.14 | >0.99 | 0.18 | 5.18 ± 1.21 | 5.68 ± 1.54 | 0.91 | 0.5 | 0.385 | |
Total bilirubin (µmol/L) | 11.63 ± 3.71 | 12.32 ± 3.93 | >0.99 | 0.68 | 12.67 ± 3.90 | 12.14 ± 4.54 | >0.99 | −0.52 | 0.200 | |
Albumin (g/L) | 40.37 ± 3.27 | 39 ± 2.90 | 0.13 | −1.37 | 41.29 ± 2.75 | 40.24 ± 1.94 | >0.99 | −1.05 | 0.198 | |
Creatinine (µmol/L) | 64.21 ± 8.86 | 66.63 ± 8.00 | 0.37 | 2.42 | 71.86 ± 15.99 | 73.27 ± 16.68 | >0.99 | 1.41 | 0.765 | |
ACR | 9.60 ± 1.37 | 8.91 ± 1.17 | 0.007 | −0.69 | 8.99 ± 2.12 | 8.58 ± 2.06 | 0.32 | −0.41 | 0.541 |
Outcome Variable | Carnosine Group (n = 20) | Placebo Group (n = 23) | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Baseline | Follow-Up | p a | Change | Baseline | Follow-Up | p b | Change | p c | ||
EndoPAT | SBP (mmHg) | 122.76 ± 14.77 d | 121.24 ± 13.17 | >0.99 | −1.53 | 122.72 ± 12.48 | 122.94 ± 16.41 | >0.99 | 0.22 | 0.667 |
DBP (mmHg) | 80.65 ± 8.25 | 79.59 ± 7.59 | >0.99 | −1.47 | 82.11 ± 7.07 | 82.50 ± 9.40 | >0.99 | 0.67 | 0.421 | |
BMI (kg/m2) | 29.73 ± 4.28 | 29.68 ± 4.31 | >0.99 | −0.09 | 27.81 ± 2.88 | 27.73 ± 3.08 | >0.99 | −0.07 | 0.981 | |
LnRHI | 1 ± 0.2 | 0.75 ± 0.22 | >0.99 | −0.24 | 0.96 ± 0.68 | 0.68 ± 0.28 | >0.99 | −0.27 | 0.437 | |
HR (bpm) | 65.53 ± 9.50 | 67.12 ± 7.83 | >0.99 | 1.76 | 69.61 ± 11.34 | 68.94 ± 6.83 | >0.99 | 0.39 | 0.923 | |
AI% | 2.24 ± 8.12 | 5.53 ± 13.24 | >0.99 | 3.53 | 7.61 ± 10.01 | 4.89 ± 18.64 | >0.99 | −2.39 | 0.321 | |
AI@75bpm (%) | 0.24 ± 12.26 | 2.24 ± 12.60 | >0.99 | 2.24 | 7.35 ± 14.12 | 7.18 ± 12.25 | >0.99 | 2.41 | 0.579 | |
HRV (ms) | 29.85 ± 12.01 | 30.27 ± 10.92 | >0.99 | 0.41 | 33.57 ± 6.31 | 36.57 ± 13.19 | >0.99 | 2.99 | 0.420 | |
LF (m/s2) | 224.05 ± 64.71 | 190.71 ± 74.23 | >0.99 | −33.33 | 185.10 ± 77.38 | 135.38 ± 55.18 | >0.99 | −49.71 | 0.132 | |
HF (m/s2) | 88.70 ± 50.17 | 126.06 ± 59.64 | >0.99 | 37.36 | 123.21 ± 36.25 | 125.94 ± 74.14 | >0.99 | 2.72 | 0.570 | |
LF/HF | 3.05 ± 1.34 | 1.82 ± 0.94 | 0.08 | −1.22 | 1.78 ± 1.51 | 1.27 ± 0.82 | >0.99 | −0.42 | 0.562 | |
Complior | Peripheral BP | |||||||||
SBP (mmHg) | 120.44 ± 15.37 | 124.07 ± 10.37 | >0.99 | 3.63 | 120.03 ± 11.87 | 120.9 ± 12.16 | >0.99 | 0.86 | 0.334 | |
DBP (mmHg) | 78.6 ± 8.6 | 79.03 ± 5.77 | >0.99 | 0.37 | 80.72 ± 6.56 | 79.04 ± 8.51 | >0.99 | −1.67 | 0.724 | |
MAP (mmHg) | 93.05 ± 9.88 | 94.24 ± 5.71 | >0.99 | 1.18 | 93.57 ± 7.25 | 92.7 ± 8.39 | >0.99 | −0.85 | 0.451 | |
PP (mmHg) | 42.27 ± 10.38 | 45.23 ± 11.26 | >0.99 | 2.96 | 39.25 ± 10.39 | 41.80 ± 8.50 | >0.99 | 2.55 | 0.573 | |
HR (bpm) | 63.17 ± 8.82 | 67.41 ± 9.84 | >0.99 | 4.24 | 70 ± 10.77 | 70.67 ± 8.94 | >0.99 | 0.67 | 0.985 | |
Central BP | ||||||||||
cSBP (mmHg) | 114.74 ± 17.74 | 116.08 ± 10.89 | >0.99 | 1.34 | 115.3 ± 14.56 | 110.67 ± 13.50 | >0.99 | −4.65 | 0.095 | |
cDBP (mmHg) | 78.81 ± 8.91 | 79.23 ± 6.09 | >0.99 | 0.42 | 81 ± 7.06 | 80.1 ± 8.30 | >0.99 | −0.9 | 1.00 | |
cPP (mmHg) | 36.42 ± 10.7 | 38.37 ± 10.23 | >0.99 | 1.94 | 34.45 ± 12.51 | 32.01 ± 9.53 | >0.99 | −2.43 | 0.123 | |
PP amplification (mmHg) | 1.19 ± 0.23 | 1.22 ± 0.27 | >0.99 | 0.02 | 1.18 ± 0.21 | 1.35 ± 0.23 | >0.99 | 0.17 | 0.127 | |
Pulse wave analysis | ||||||||||
CF PWV (m/s) | 7.4 (6.2–8.5) e | 7.6 (2.4–8.5) | >0.99 | −1.19 | 7.1 (5.7–7.8) | 7.1 (6.5–8.4) | >0.99 | 0.23 | 0.123 | |
Alx (%) | 13.9 (−13.8–18.9) | 8.2 (−17.8–15.7) | >0.99 | −6.87 | 9.2 (−26.9–25.3) | 13.1 (−7.6–25) | >0.99 | 9.07 | 0.339 | |
AP (mmHg) | 9.6 (4.5–12.3) | 7.6 (4.8–14) | >0.99 | −0.46 | 7.5 (4.2–16.5) | 8 (3.2–15.7) | >0.99 | −1.8 | 0.585 | |
SEVR (%) | 105.22 ± 46.60 | 99.05 ± 42.24 | >0.99 | −6.17 | 102.28 ± 50.23 | 109.62 ± 47.36 | >0.99 | 7.33 | 0.482 | |
LVET (ms) | 415.51 ± 80.20 | 430.90 ± 121.32 | >0.99 | 15.38 | 406.62 ± 135.64 | 386.25 ± 86.80 | >0.99 | −20.37 | 0.227 | |
Max dp/dt (mmHg/s) | 720 (499.9–940) | 896.6 (643.3–1021.6) | >0.99 | 110.42 | 584.1 (456.6–793.7) | 661.6 (343.3–822.5) | >0.99 | −76.85 | 0.055 |
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Share and Cite
Saadati, S.; Cameron, J.; Menon, K.; Hodge, A.; Lu, Z.X.; de Courten, M.; Feehan, J.; de Courten, B. Carnosine Did Not Affect Vascular and Metabolic Outcomes in Patients with Prediabetes and Type 2 Diabetes: A 14-Week Randomized Controlled Trial. Nutrients 2023, 15, 4835. https://doi.org/10.3390/nu15224835
Saadati S, Cameron J, Menon K, Hodge A, Lu ZX, de Courten M, Feehan J, de Courten B. Carnosine Did Not Affect Vascular and Metabolic Outcomes in Patients with Prediabetes and Type 2 Diabetes: A 14-Week Randomized Controlled Trial. Nutrients. 2023; 15(22):4835. https://doi.org/10.3390/nu15224835
Chicago/Turabian StyleSaadati, Saeede, James Cameron, Kirthi Menon, Alexander Hodge, Zhong X. Lu, Maximilian de Courten, Jack Feehan, and Barbora de Courten. 2023. "Carnosine Did Not Affect Vascular and Metabolic Outcomes in Patients with Prediabetes and Type 2 Diabetes: A 14-Week Randomized Controlled Trial" Nutrients 15, no. 22: 4835. https://doi.org/10.3390/nu15224835