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1Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea
2CJ Foods R&D, CJ CheilJedang Corporation, Suwon, Korea
3CJ CheilJedang Corporation, Suwon, Korea
Copyright © 2020 Korean Endocrine Society
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
AUTHOR CONTRIBUTIONS
Conception or design: S.L. Acquisition, analysis, or interpretation of data: S.L., J.H.M., D.J., B.K. Drafting the work: S.L. Final approval of the manuscript: S.L., J.H.M., C.M.S., D.J., B.K.
CONFLICTS OF INTEREST
This study was supported by a research grant from the CJ Foods R&D, CJ CheilJedang Corporation, Suwon, Korea and by the Korean Endocrine Society of Endocrinology and Metabolism Research Award 2019. The funders had no role in study design, data collection and analysis, or preparation of the manuscript.
Values are expressed as number (%) or mean±standard deviation.
SBP, systolic blood pressure; DBP, diastolic blood pressure; HbA1c, glycated hemoglobin; HOMA-IR, homeostasis model assessment of insulin resistance; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; ALP, alkaline phosphatase; AST, aspartate aminotransferase; ALT, alanine aminotransferase; BUN, blood urea nitrogen; TSH, thyroid stimulating hormone.
Variable | L. sakei (CJLS03) (n=47) | Placebo (n=48) | P valuea | ||||
---|---|---|---|---|---|---|---|
|
|
||||||
Baseline | 12 weeks | P value | Baseline | 12 weeks | P value | ||
Body weight, kg | 73.0±8.6 | 72.6±8.6 | 0.352 | 76.7±10.4 | 77.2±11.0 | 0.034 | 0.058 |
|
|||||||
Body mass index, kg/m2 | 28.2±2.3 | 28.0±2.5 | 0.360 | 28.5±2.5 | 28.7±2.7 | 0.033 | 0.065 |
|
|||||||
Body fat, kg | 27.0±5.1 | 26.8±5.3 | 0.454 | 27.4±5.8 | 28.0±6.1 | 0.003 | 0.018 |
|
|||||||
Waist circumference, cm | 91.0±5.6 | 90.3±5.6 | 0.017 | 91.1±7.1 | 91.3±7.6 | 0.301 | 0.013 |
|
|||||||
Abdominal visceral fat, cm2 | 131.7±33.5 | 130.7±34.6 | 0.554 | 131.4±32.7 | 134.6±34.0 | 0.003 | 0.035 |
|
|||||||
Whole body muscle mass, kg | 41.5±7.6 | 41.3±7.6 | 0.203 | 44.5±9.4 | 44.4±9.3 | 0.139 | 0.853 |
Variable | L. sakei (CJLS03) (n=47) | Placebo (n=48) | P valuea | ||||
---|---|---|---|---|---|---|---|
|
|
||||||
Baseline | 12 weeks | P value | Baseline | 12 weeks | P value | ||
SBP, mm Hg | 126.0±12.9 | 128.6±10.0 | 0.131 | 124.6±11.2 | 126.2±10.8 | 0.251 | 0.678 |
|
|||||||
DBP, mm Hg | 78.4±10.2 | 78.0±9.6 | 0.788 | 75.4±8.8 | 78.8±9.5 | 0.003 | 0.026 |
|
|||||||
Fasting glucose, mg/dL | 101.8±10.8 | 102.5±15.8 | 0.659 | 103.8±17.7 | 103.1±13.4 | 0.690 | 0.553 |
|
|||||||
HbA1c, % | 5.7±0.4 | 5.8±0.5 | 0.223 | 5.6±0.7 | 5.6±0.5 | 0.170 | 0.672 |
|
|||||||
Insulin, μIU/mL | 10.9±3.9 | 11.5±6.9 | 0.514 | 11.5±4.9 | 13.1±9.6 | 0.217 | 0.487 |
|
|||||||
HOMA-IR | 2.8±1.1 | 2.9±1.8 | 0.444 | 3.0±2.0 | 3.4±2.7 | 0.283 | 0.583 |
|
|||||||
Glucagon, pg/mL | 174.8±131.6 | 180.7±138.4 | 0.603 | 167.2±111.0 | 163.0±100.2 | 0.689 | 0.512 |
|
|||||||
Uric acid, mg/dL | 5.1±1.1 | 5.0±1.1 | 0.088 | 5.6±1.6 | 5.6±1.6 | 0.659 | 0.404 |
|
|||||||
Protein, g/dL | 7.4±0.3 | 7.4±0.4 | 0.447 | 7.4±0.4 | 7.4±0.3 | 0.397 | 0.255 |
|
|||||||
Albumin, g/dL | 4.4±0.2 | 4.4±0.2 | 0.945 | 4.4±0.2 | 4.5±0.2 | 0.013 | 0.091 |
|
|||||||
Total bilirubin, mg/dL | 0.73±0.22 | 0.75±0.29 | 0.409 | 0.79±0.30 | 0.77±0.27 | 0.404 | 0.239 |
|
|||||||
Total cholesterol, mg/dL | 201.3±28.4 | 197.4±43.2 | 0.465 | 199.0±36.1 | 205.2±40.7 | 0.058 | 0.105 |
|
|||||||
Triglyceride, mg/dL | 125.6±64.1 | 129.0±83.2 | 0.754 | 128.3±62.0 | 134.2±63.5 | 0.461 | 0.850 |
|
|||||||
HDL-C, mg/dL | 54.4±9.7 | 55.1±9.6 | 0.375 | 52.6±11.4 | 53.5±9.6 | 0.387 | 0.907 |
|
|||||||
LDL-C, mg/dL | 116.8±20.4 | 115.6±24.0 | 0.620 | 117.1±27.4 | 118.2±28.6 | 0.626 | 0.486 |
|
|||||||
Apolipoprotein A1, mg/dL | 142.3±17.0 | 144.1±15.8 | 0.242 | 138.3±22.9 | 139.9±18.2 | 0.480 | 0.913 |
|
|||||||
Apolipoprotein B, mg/dL | 105.2±18.3 | 104.9±20.0 | 0.849 | 104.5±23.1 | 108.9±30.3 | 0.082 | 0.136 |
|
|||||||
Free fatty acid, μEq/L | 675.2±250.9 | 574.9±217.1 | 0.011 | 563.9±199.8 | 569.7±216.3 | 0.868 | 0.041 |
|
|||||||
ALP, IU/L | 75.2±21.3 | 78.2±23.0 | 0.117 | 70.0±16.4 | 72.6±17.7 | 0.020 | 0.870 |
|
|||||||
AST, IU/L | 26.3±12.2 | 27.5±21.7 | 0.572 | 24.8±8.3 | 27.2±12.8 | 0.074 | 0.620 |
|
|||||||
ALT, IU/L | 28.4±21.4 | 30.3±34.0 | 0.594 | 26.8±17.8 | 35.0±46.9 | 0.197 | 0.390 |
|
|||||||
BUN, mg/dL | 12.6±3.4 | 12.8±3.2 | 0.576 | 13.4±3.2 | 13.7±3.6 | 0.428 | 0.855 |
|
|||||||
Creatinine, mg/dL | 0.69±0.16 | 0.69±0.17 | 0.745 | 0.74±0.18 | 0.73±0.18 | 0.497 | 0.461 |
|
|||||||
Calcium, mg/dL | 9.2±0.3 | 9.2±0.3 | 0.879 | 9.2±0.3 | 9.3±0.3 | 0.041 | 0.144 |
|
|||||||
Phosphorus, mg/dL | 3.6±0.4 | 3.5±0.4 | 0.052 | 3.5±0.5 | 3.5±0.5 | 0.679 | 0.273 |
Values are expressed as mean±standard deviation. P values were calculated using paired t tests between the baseline and after 12 weeks.
SBP, systolic blood pressure; DBP, diastolic blood pressure; HbA1c, glycated hemoglobin; HOMA-IR, homeostasis model assessment of insulin resistance; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; ALP, alkaline phosphatase; AST, aspartate aminotransferase; ALT, alanine aminotransferase; BUN, blood urea nitrogen.
a P values were calculated using Student’s t test for the difference between groups in the change from the baseline to 12 weeks.
Characteristic | CJLS03 (n=57) | Placebo (n=57) | P value |
---|---|---|---|
Men | 14 (24.6) | 17 (29.8) | 0.674 |
Age, yr | 46.4±12.2 | 47.2±11.2 | 0.707 |
Height, cm | 161.5±8.1 | 163.2±8.6 | 0.292 |
Weight, kg | 74.4±9.4 | 75.6±10.6 | 0.521 |
Body mass index, kg/m2 | 28.5±2.4 | 28.3±2.4 | 0.695 |
Waist circumference, cm | 91.4±6.0 | 90.4±7.2 | 0.460 |
SBP, mm Hg | 126.5±13.4 | 124.3±11.3 | 0.358 |
DBP, mm Hg | 78.5±10.4 | 75.6±8.8 | 0.112 |
Fasting plasma glucose, mg/dL | 103.8±18.6 | 103.4±16.9 | 0.900 |
HbA1c, % | 5.8±0.7 | 5.6±0.6 | 0.118 |
Insulin, μIU/mL | 10.7±3.8 | 11.1±4.6 | 0.634 |
HOMA-IR | 2.8±1.3 | 2.9±1.8 | 0.677 |
Glucagon, pg/mL | 176.1±132.5 | 160.8±104.6 | 0.494 |
Uric acid, mg/dL | 5.2±1.1 | 5.6±1.6 | 0.131 |
Protein, g/dL | 7.4±0.3 | 7.3±0.4 | 0.444 |
Albumin, g/dL | 4.4±0.2 | 4.4±0.2 | 0.592 |
Total bilirubin, mg/dL | 0.74±0.28 | 0.79±0.29 | 0.357 |
Total cholesterol, mg/dL | 199.3±32.0 | 199.1±39.8 | 0.975 |
Triglyceride, mg/dL | 122.2±61.2 | 125.8±59.5 | 0.753 |
HDL-C, mg/dL | 54.1±10.3 | 52.9±11.1 | 0.552 |
LDL-C, mg/dL | 116.4±24.0 | 116.5±30.1 | 0.973 |
Apolipoprotein A1, mg/dL | 141.2±17.7 | 138.4±22.1 | 0.464 |
Apolipoprotein B, mg/dL | 104.6±21.4 | 104.1±25.5 | 0.915 |
Free fatty acid, μEq/L | 667.2±249.4 | 599.6±232.2 | 0.137 |
ALP, IU/L | 75.1±21.9 | 70.0±17.9 | 0.172 |
AST, IU/L | 26.3±12.4 | 23.9±8.0 | 0.218 |
ALT, IU/L | 28.8±21.7 | 25.1±16.8 | 0.314 |
BUN, mg/dL | 12.6±3.6 | 13.2±3.2 | 0.369 |
Creatinine, mg/dL | 0.71±0.16 | 0.71±0.18 | 0.852 |
Calcium, mg/dL | 9.2±0.3 | 9.2±0.3 | 0.180 |
Phosphorus, mg/dL | 3.6±0.5 | 3.5±0.5 | 0.118 |
TSH, μIU/mL | 2.1±1.2 | 2.0±0.9 | 0.815 |
Variable | L. sakei (CJLS03) (n=47) | Placebo (n=48) | P value | ||||
---|---|---|---|---|---|---|---|
|
| ||||||
Baseline | 12 weeks | P value | Baseline | 12 weeks | P value | ||
Body weight, kg | 73.0±8.6 | 72.6±8.6 | 0.352 | 76.7±10.4 | 77.2±11.0 | 0.034 | 0.058 |
| |||||||
Body mass index, kg/m2 | 28.2±2.3 | 28.0±2.5 | 0.360 | 28.5±2.5 | 28.7±2.7 | 0.033 | 0.065 |
| |||||||
Body fat, kg | 27.0±5.1 | 26.8±5.3 | 0.454 | 27.4±5.8 | 28.0±6.1 | 0.003 | 0.018 |
| |||||||
Waist circumference, cm | 91.0±5.6 | 90.3±5.6 | 0.017 | 91.1±7.1 | 91.3±7.6 | 0.301 | 0.013 |
| |||||||
Abdominal visceral fat, cm2 | 131.7±33.5 | 130.7±34.6 | 0.554 | 131.4±32.7 | 134.6±34.0 | 0.003 | 0.035 |
| |||||||
Whole body muscle mass, kg | 41.5±7.6 | 41.3±7.6 | 0.203 | 44.5±9.4 | 44.4±9.3 | 0.139 | 0.853 |
Variable | L. sakei (CJLS03) (n=47) | Placebo (n=48) | P value | ||||
---|---|---|---|---|---|---|---|
|
| ||||||
Baseline | 12 weeks | P value | Baseline | 12 weeks | P value | ||
SBP, mm Hg | 126.0±12.9 | 128.6±10.0 | 0.131 | 124.6±11.2 | 126.2±10.8 | 0.251 | 0.678 |
| |||||||
DBP, mm Hg | 78.4±10.2 | 78.0±9.6 | 0.788 | 75.4±8.8 | 78.8±9.5 | 0.003 | 0.026 |
| |||||||
Fasting glucose, mg/dL | 101.8±10.8 | 102.5±15.8 | 0.659 | 103.8±17.7 | 103.1±13.4 | 0.690 | 0.553 |
| |||||||
HbA1c, % | 5.7±0.4 | 5.8±0.5 | 0.223 | 5.6±0.7 | 5.6±0.5 | 0.170 | 0.672 |
| |||||||
Insulin, μIU/mL | 10.9±3.9 | 11.5±6.9 | 0.514 | 11.5±4.9 | 13.1±9.6 | 0.217 | 0.487 |
| |||||||
HOMA-IR | 2.8±1.1 | 2.9±1.8 | 0.444 | 3.0±2.0 | 3.4±2.7 | 0.283 | 0.583 |
| |||||||
Glucagon, pg/mL | 174.8±131.6 | 180.7±138.4 | 0.603 | 167.2±111.0 | 163.0±100.2 | 0.689 | 0.512 |
| |||||||
Uric acid, mg/dL | 5.1±1.1 | 5.0±1.1 | 0.088 | 5.6±1.6 | 5.6±1.6 | 0.659 | 0.404 |
| |||||||
Protein, g/dL | 7.4±0.3 | 7.4±0.4 | 0.447 | 7.4±0.4 | 7.4±0.3 | 0.397 | 0.255 |
| |||||||
Albumin, g/dL | 4.4±0.2 | 4.4±0.2 | 0.945 | 4.4±0.2 | 4.5±0.2 | 0.013 | 0.091 |
| |||||||
Total bilirubin, mg/dL | 0.73±0.22 | 0.75±0.29 | 0.409 | 0.79±0.30 | 0.77±0.27 | 0.404 | 0.239 |
| |||||||
Total cholesterol, mg/dL | 201.3±28.4 | 197.4±43.2 | 0.465 | 199.0±36.1 | 205.2±40.7 | 0.058 | 0.105 |
| |||||||
Triglyceride, mg/dL | 125.6±64.1 | 129.0±83.2 | 0.754 | 128.3±62.0 | 134.2±63.5 | 0.461 | 0.850 |
| |||||||
HDL-C, mg/dL | 54.4±9.7 | 55.1±9.6 | 0.375 | 52.6±11.4 | 53.5±9.6 | 0.387 | 0.907 |
| |||||||
LDL-C, mg/dL | 116.8±20.4 | 115.6±24.0 | 0.620 | 117.1±27.4 | 118.2±28.6 | 0.626 | 0.486 |
| |||||||
Apolipoprotein A1, mg/dL | 142.3±17.0 | 144.1±15.8 | 0.242 | 138.3±22.9 | 139.9±18.2 | 0.480 | 0.913 |
| |||||||
Apolipoprotein B, mg/dL | 105.2±18.3 | 104.9±20.0 | 0.849 | 104.5±23.1 | 108.9±30.3 | 0.082 | 0.136 |
| |||||||
Free fatty acid, μEq/L | 675.2±250.9 | 574.9±217.1 | 0.011 | 563.9±199.8 | 569.7±216.3 | 0.868 | 0.041 |
| |||||||
ALP, IU/L | 75.2±21.3 | 78.2±23.0 | 0.117 | 70.0±16.4 | 72.6±17.7 | 0.020 | 0.870 |
| |||||||
AST, IU/L | 26.3±12.2 | 27.5±21.7 | 0.572 | 24.8±8.3 | 27.2±12.8 | 0.074 | 0.620 |
| |||||||
ALT, IU/L | 28.4±21.4 | 30.3±34.0 | 0.594 | 26.8±17.8 | 35.0±46.9 | 0.197 | 0.390 |
| |||||||
BUN, mg/dL | 12.6±3.4 | 12.8±3.2 | 0.576 | 13.4±3.2 | 13.7±3.6 | 0.428 | 0.855 |
| |||||||
Creatinine, mg/dL | 0.69±0.16 | 0.69±0.17 | 0.745 | 0.74±0.18 | 0.73±0.18 | 0.497 | 0.461 |
| |||||||
Calcium, mg/dL | 9.2±0.3 | 9.2±0.3 | 0.879 | 9.2±0.3 | 9.3±0.3 | 0.041 | 0.144 |
| |||||||
Phosphorus, mg/dL | 3.6±0.4 | 3.5±0.4 | 0.052 | 3.5±0.5 | 3.5±0.5 | 0.679 | 0.273 |
Variable | L. sakei (CJLS03) (n=47) | Placebo (n=48) | P value |
---|---|---|---|
Gastrointestinal discomfort | 15 (31.9) | 13 (27.1) | 0.657 |
Loose stools | 18 (38.3) | 18 (37.5) | 1.000 |
Fecal urgency | 17 (36.2) | 17 (35.4) | 1.000 |
Flatulence | 17 (36.2) | 17 (35.4) | 1.000 |
Values are expressed as number (%) or mean±standard deviation. SBP, systolic blood pressure; DBP, diastolic blood pressure; HbA1c, glycated hemoglobin; HOMA-IR, homeostasis model assessment of insulin resistance; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; ALP, alkaline phosphatase; AST, aspartate aminotransferase; ALT, alanine aminotransferase; BUN, blood urea nitrogen; TSH, thyroid stimulating hormone.
Values are expressed as mean±standard deviation.
Values are expressed as mean±standard deviation. SBP, systolic blood pressure; DBP, diastolic blood pressure; HbA1c, glycated hemoglobin; HOMA-IR, homeostasis model assessment of insulin resistance; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; ALP, alkaline phosphatase; AST, aspartate aminotransferase; ALT, alanine aminotransferase; BUN, blood urea nitrogen.
Values are expressed as number (%).