Effect of Nutrition Education in NAFLD Patients Undergoing Simultaneous Hyperlipidemia Pharmacotherapy: A Randomized Controlled Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Patients and Study Design
2.2. Randomization and Concealment
2.3. Evaluation of Patients
2.4. Diagnosis of Fatty Liver
2.5. Protocol of NAFLD Specific Nutrition Education (MNT Group) and Nutritional Education Paper Materials (Control Group)
2.6. Primary and Secondary Outcomes
2.7. Sample Size Calculation
2.8. Statistical Analysis
3. Results
3.1. Baseline Characteristics
3.2. Comparison of Effects of Nutrition Education between Variables
3.3. Effect of Nutritional Education on Serum ALT Level
3.4. Effect of Nutritional Education on Steatosis, Metabolic and Fibrosis Factors
4. Discussion
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Acknowledgments
Conflicts of Interest
References
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Characteristics | All (n = 48) | Control (n = 21) | MNT (n = 27) | p |
---|---|---|---|---|
Demographics | ||||
Age (years)—mean ± SD | 41 ± 12 | 39 ± 11 | 42 ± 12 | 0.390 |
Sex (male)—number (percent) | 30 (62.5) | 12 (57) | 18 (66.6) | |
Laboratory values—mean ± SD | ||||
White blood cell count (103/µL) | 7.1 ± 2.0 | 7.7 ± 1.9 | 6.6 ± 2.0 | 0.059 |
Hemoglobin (g/dL) | 15.0 ± 1.1 | 14.9 ± 1.2 | 15.1 ± 1.0 | 0.594 |
Platelet count (103/µL) | 260 ± 45 | 280 ± 49 | 245 ± 37 | 0.009 |
AST (IU/L) | 48 ± 28 | 47 ± 35 | 49 ± 23 | 0.891 |
ALT (IU/L) | 73 ± 42 | 71 ± 34 | 75 ± 48 | 0.713 |
Total bilirubin (mg/dL) | 0.8 ± 0.3 | 0.8 ± 0.4 | 0.7 ± 0.2 | 0.355 |
Serum albumin (g/dL) | 4.7 ± 0.3 | 4.72 ± 0.32 | 4.78 ± 0.31 | 0.494 |
Prothromin time (INR) | 1.0 ± 0.1 | 1.0 ± 0.1 | 1.0 ± 0.1 | 0.438 |
Serum creatinine (mg/dL) | 1.0 ± 0.2 | 1.0 ± 0.2 | 1.0 ± 0.2 | 0.688 |
Serum ferritin (ng/mL) | 361 ± 546 | 436 ± 742 | 279 ± 149 | 0.351 |
Lipid profiles—mean ± SD | ||||
Total cholesterol (mg/dL) | 239 ± 34 | 243 ± 33 | 235 ± 34 | 0.437 |
LDL cholesterol (mg/dL) | 168 ± 23 | 171 ± 24 | 167 ± 22 | 0.562 |
HDL cholesterol (mg/dL) | 45 ± 9 | 45 ± 11 | 45 ± 9.1 | 0.815 |
Triglyceride (mg/dL) | 188 ± 98 | 163 ± 62 | 207 ± 117 | 0.100 |
Diabetes related laboratory values—mean ± SD | ||||
HbA1C (%) | 5.7 ± 0.3 | 5.7 ± 0.3 | 5.7 ± 0.3 | 0.599 |
Fasting glucose (mg/dL) | 106 ± 12 | 105 ± 10 | 106 ± 13 | 0.673 |
Serum Insulin (uIU/mL) | 37 ± 62 | 28 ± 21 | 43 ± 81 | 0.361 |
C-peptide (ng/mL) | 5.2 ± 3.8 | 4.7 ± 2.5 | 5.6 ± 4.6 | 0.370 |
HOMA-IR | 165 ±257 | 130 ± 92 | 192 ± 333 | 0.362 |
Anthropometric values—mean ± SD | ||||
BMI (kg/m2) | 30.1 ± 4.3 | 30.0 ± 3.5 | 30.1 ± 4.8 | 0.933 |
Muscle mass (kg) | 31.2 ± 8.4 | 29.4 ± 6.3 | 32.6 ± 9.6 | 0.168 |
Body fat percentage (%) | 34.6 ± 8.2 | 35.3 ± 8.4 | 34.0 ± 8.2 | 0.602 |
Noninvasive scoring system scores—mean ± SD | ||||
CAP score (dB/m) | 325 ± 56 | 327 ± 76 | 323 ± 36 | 0.840 |
Fibrosis score (kPa) | 7.0 ± 4.2 | 6.5 ± 2.5 | 7.4 ± 5.2 | 0.422 |
FIB-4 | 1.0 ± 0.6 | 0.8 ± 0.4 | 1.1 ± 0.6 | 0.106 |
Hepatic steatosis index | 43.6 ± 6.0 | 43.7 ± 4.9 | 43.5 ± 6.9 | 0.909 |
NAFLD fat score | 5.6 ± 9.4 | 4.3 ± 3.4 | 6.7 ± 12.3 | 0.352 |
NAFLD fibrosis score | −3.1 ± 1.3 | −3.5 ± 1.2 | −2.8 ± 1.3 | 0.063 |
USG fatty liver grade (%) | 0.013 | |||
Grade I | 8 (16.6) | 6 (28.5) | 2 (7.41) | |
Grade II | 20 (41.6) | 4 (19) | 16 (59.2) | |
Grade III | 20 (41.6) | 11 (52.3) | 9 (33.3) |
Characteristics | Control (n = 21) | MNT (n = 27) | ||||||
---|---|---|---|---|---|---|---|---|
Baseline | 48 w | Mean Difference (95% CI) | p | Baseline | 48 w | Mean Difference (95% CI) | p | |
Primary outcome | ||||||||
ALT (IU/L) | 71 ± 34 | 66 ± 37 | −4.8 (−26.8, 17.2) | 0.051 | 75 ± 48 | 57 ± 36 | −18.4 (−33.5, −3.2) | 0.019 |
Steatosis factors | ||||||||
AST (IU/L) | 47 ± 35 | 37 ± 17 | −10.3 (−27.1, 0.5) | 0.215 | 49 ± 23 | 36 ± 15 | −12.9 (−20.3, −5.46) | 0.001 |
CAP score (dB/m) | 327 ± 76 | 307 ± 43 | −20.2 (−60.2, 19.6) | 0.302 | 323 ± 36 | 301 ± 44 | −22.5 (−39.3, −5.8) | 0.010 |
NAFLD fat score | 4.3 ± 3.38 | 2.9 ± 3.26 | −1.3 (−3.2, 0.5) | 0.159 | 6.6 ± 12.2 | 2.4 ± 1.8 | −4.2 (−8.7, 0.2) | 0.065 |
Hepatic steatosis index | 43.6 ± 4.8 | 44.5 ± 4.9 | 0.8 (−1.3, 3.04) | 0.428 | 43.5 ± 6.8 | 43 ± 6.1 | −0.4 (−2.2, 1.2) | 0.565 |
USG fatty liver grade (%) | ||||||||
Grade 0 | − | − | − | 1 (3.7) | ||||
Grade I | 6 (28.5) | 6 (28.5) | 2 (7.41) | 11 (40.7) | ||||
Grade II | 4 (19) | 10 (47.6) | 16 (59.2) | 7 (25.9) | ||||
Grade III | 11 (52.3) | 5 (23.8) | 9 (33.3) | 8 (29.6) | ||||
Metabolic factors | ||||||||
Total cholesterol (mg/dL) | 243 ± 33 | 163 ± 48 | −79.8 (−103, −56) | <0.001 | 235 ± 34 | 152 ± 42 | −83.4 (−103, −63) | <0.001 |
LDL cholesterol (mg/dL) | 171 ± 24 | 95 ± 36 | −75.2 (−93.7, −56.7) | <0.001 | 167 ± 22 | 88 ± 37 | −78.1 (−95.9, −60.4) | <0.001 |
HDL cholesterol (mg/dL) | 45 ± 11 | 47 ± 9 | 1.7 (−1.9, 5.5) | 0.336 | 45 ± 9 | 48 ± 9 | 3.3 (0.7, 5.8) | 0.012 |
Triglyceride (mg/dL) | 163 ± 62 | 166 ± 106 | 2.4 (−38, 2.9) | 0.901 | 207 ± 117 | 145 ± 51 | −62.2 (−107.8, −16.5) | 0.009 |
BMI (kg/m2) | 29.9 ± 3.5 | 29.8 ± 3.7 | −0.1 (−0.6, 0.2) | 0.450 | 30.0 ± 4.8 | 29.7 ± 4.5 | −0.3 (−0.8, 0.2) | 0.251 |
Muscle mass (kg) | 29.3 ± 6.2 | 29.5 ± 6.3 | 0.1 (−0.1, 0.4) | 0.332 | 32.5 ± 9.6 | 31.1 ± 7.4 | −1.4 (−3.5, 0.6) | 0.164 |
Body fat percentage (%) | 35.3 ± 8.3 | 36 ± 7.2 | 0.7 (−2.2, 3.6) | 0.620 | 34 ± 8.2 | 33.4 ± 8.3 | −0.6 (−1.7, 0.4) | 0.236 |
HOMA-IR | 130 ± 92 | 115 ± 99 | −15.1 (−70.1, 39.9) | 0.573 | 192 ± 333 | 100 ± 56 | −91.5(−212, 29.3) | 0.131 |
Fasting glucose (mg/dL) | 105 ± 10 | 105 ± 13 | −0.1 (−5.3, 5.1) | 0.970 | 106 ± 13 | 108 ± 11 | 1.4 (−2.1, 5) | 0.402 |
Fibrosis factors | ||||||||
NAFLD fibrosis score | −3.4 ± 1.1 | −3.7 ± 1.5 | −0.3 (−0.8, 0.1) | 0.186 | −2.7 ± 1.3 | −2.7 ± 1.3 | 0 (−0.3, 0.3) | 0.998 |
Fibrosis score (kPa) | 6.4 ± 2.5 | 5.5 ± 1.8 | −0.9 (−1.9, 0.1) | 0.085 | 7.3 ± 5.1 | 5.4 ± 1.4 | −1.9 (−3.9, 0) | 0.053 |
FIB-4 | 0.8 ± 0.4 | 0.7 ± 0.4 | −0.1 (−0.2, 0) | 0.234 | 1.0 ± 0.6 | 0.8 ± 0.5 | −0.2 (−0.3, 0) | 0.003 |
Characteristics | Control (n = 21) | MNT (n = 27) | p1 * | p2 * | ||
---|---|---|---|---|---|---|
24 w | 48 w | 24 w | 48 w | |||
Primary outcome | ||||||
ALT (IU/L) | 61 ± 25 | 66 ± 37 | 77 ± 57 | 57 ± 36 | 0.246 | 0.400 |
Steatosis factors | ||||||
AST (IU/L) | 35 ± 11 | 37 ± 17 | 48 ± 33 | 36 ± 15 | 0.075 | 0.776 |
CAP score (dB/m) | 299 ± 32 | 307 ± 43 | 297 ± 34 | 301 ± 44 | 0.831 | 0.642 |
NAFLD fat score | 3.0 ± 2.5 | 2.9 ± 3.2 | 2.8 ± 2.0 | 2.4 ± 1.8 | 0.677 | 0.489 |
Hepatic steatosis index | 44.5 ± 4.4 | 44.5 ± 4.9 | 43.3 ± 4.8 | 43.0 ± 6.1 | 0.389 | 0.354 |
USG fatty liver grade (%) | NA | 0.574 | ||||
Grade 0 | NA | - | NA | 1 (3.7) | ||
Grade I | NA | 6 (28.5) | NA | 11 (40.7) | ||
Grade II | NA | 10 (47.6) | NA | 7 (25.9) | ||
Grade III | NA | 5 (23.8) | NA | 8 (29.6) | ||
Metabolic factors | ||||||
Total cholesterol (mg/dL) | 156 ± 43 | 163 ± 48 | 135 ± 28 | 152 ± 42 | 0.051 | 0.392 |
LDL cholesterol (mg/dL) | 87 ± 31 | 95 ± 36 | 75 ± 24 | 87 ± 37 | 0.140 | 0.456 |
HDL cholesterol (mg/dL) | 47 ± 9 | 47 ± 9 | 45 ± 7 | 48 ± 9 | 0.408 | 0.767 |
Triglyceride (mg/dL) | 173 ± 128 | 166 ± 106 | 137 ± 47 | 145 ± 51 | 0.230 | 0.381 |
BMI (kg/m2) | 29.8 ± 3.9 | 29.8 ± 3.7 | 29.5 ± 4.1 | 29.7 ± 4.5 | 0.845 | 0.974 |
Muscle mass (kg) | 29.4 ± 6.5 | 29.5 ± 6.3 | 30.9 ± 7.1 | 31.1 ± 7.4 | 0.443 | 0.427 |
Body fat percentage (%) | 35.9 ± 8.2 | 36.0 ± 7.2 | 33.5 ± 7.7 | 33.4 ± 8.3 | 0.312 | 0.261 |
HOMA-IR | 121 ± 77 | 115 ± 99 | 101 ± 50 | 100 ± 56 | 0.285 | 0.529 |
Fasting glucose (mg/dL) | 105 ± 15 | 105 ± 13 | 109 ± 18 | 108 ± 11 | 0.403 | 0.397 |
HbA1C (%) | NA | 5.9 ± 0.4 | NA | 5.8 ± 0.4 | NA | 0.527 |
Serum Insulin (uIU/mL) | NA | 24 ± 20 | NA | 20 ± 11 | NA | 0.442 |
C-peptide (ng/mL) | NA | 3.4 ± 1.1 | NA | 3.1 ± 1.0 | NA | 0.365 |
Fibrosis factors | ||||||
NAFLD fibrosis score | −3.6 ± 1.3 | −3.7 ± 1.5 | −2.6 ± 1.1 | −2.7 ± 1.3 | 0.012 | 0.017 |
Fibrosis score (kPa) | 6.0 ± 2.4 | 5.5 ± 1.8 | 5.7 ± 2.2 | 5.4 ± 1.4 | 0.831 | 0.810 |
FIB-4 | 0.7 ± 0.3 | 0.7 ± 0.4 | 1.0 ± 0.5 | 0.8 ± 0.5 | 0.039 | 0.345 |
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Lee, W.M.; Bae, J.H.; Chang, Y.; Lee, S.H.; Moon, J.E.; Jeong, S.W.; Jang, J.Y.; Kim, S.G.; Kim, H.S.; Yoo, J.-J.; et al. Effect of Nutrition Education in NAFLD Patients Undergoing Simultaneous Hyperlipidemia Pharmacotherapy: A Randomized Controlled Trial. Nutrients 2021, 13, 4453. https://doi.org/10.3390/nu13124453
Lee WM, Bae JH, Chang Y, Lee SH, Moon JE, Jeong SW, Jang JY, Kim SG, Kim HS, Yoo J-J, et al. Effect of Nutrition Education in NAFLD Patients Undergoing Simultaneous Hyperlipidemia Pharmacotherapy: A Randomized Controlled Trial. Nutrients. 2021; 13(12):4453. https://doi.org/10.3390/nu13124453
Chicago/Turabian StyleLee, Won Myung, Jea Hurn Bae, Young Chang, Sae Hwan Lee, Ji Eun Moon, Soung Won Jeong, Jae Young Jang, Sang Gyune Kim, Hong Soo Kim, Jeong-Ju Yoo, and et al. 2021. "Effect of Nutrition Education in NAFLD Patients Undergoing Simultaneous Hyperlipidemia Pharmacotherapy: A Randomized Controlled Trial" Nutrients 13, no. 12: 4453. https://doi.org/10.3390/nu13124453
APA StyleLee, W. M., Bae, J. H., Chang, Y., Lee, S. H., Moon, J. E., Jeong, S. W., Jang, J. Y., Kim, S. G., Kim, H. S., Yoo, J. -J., & Kim, Y. S. (2021). Effect of Nutrition Education in NAFLD Patients Undergoing Simultaneous Hyperlipidemia Pharmacotherapy: A Randomized Controlled Trial. Nutrients, 13(12), 4453. https://doi.org/10.3390/nu13124453