H. Schellekens et al. / EBioMedicine xxx (xxxx) 103176
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Table 2 Human lipid, and inflammatory profiles. Placebo ( n =48)
B. longum APC1472 ( n =74)
Placebo vs B. Longum APC1472
P-value Week 0 – 12
P-value Week 0 – 12
Difference (95% CI)
P- value
η 2
Variable
Week 0
Week 6
Week 12
Week 0
Week 6
Week 12
Lipid profile Cholesterol (mmol/L) Triglycerides (mmol/L)
5.50 ± 0.12 5.42 ± 0.13 5.34 ± 0.15 0.310
5.45 ± 0.12 5.48 ± 0.12 5.41 ± 0.10 0.691
0.094 ( − 0.22 to 0.41) 0.089 ( − 0.14 to 0.31) − 0.083 ( − 0.38 to 0.21) 0.091 ( − 0.01 to 0.19) − 0.012 ( − 0.15 to 0.13) − 0.013 ( − 0.14 to 0.11) − 0.017 (8.29 to 8.26)
0.556 0.003
1.50 ± 0.13 1.47 ± 0.11 1.41 ± 0.09 0.412
1.46 ± 0.10 1.43 ± 0.08 1.49 ± 0.10 0.778
0.432 0.005
LDL (mmol/L HDL (mmol/L)
3.72 ± 0.13 3.70 ± 0.12 3.75 ± 0.15 0.896
3.73 ± 0.12 3.81 ± 0.11 3.66 ± 0.10 0.473
0.579 0.003
1.33 ± 0.04 1.34 ± 0.05 1.29 ± 0.05 0.537
1.29 ± 0.04 1.32 ± 0.04 1.36 ± 0.04 0.039
0.074 0.027
Inflammatory profile IL-10 (pg/ml)
0.43 ± 0.06 0.46 ± 0.06 0.42 ± 0.05 0.696
0.36 ± 0.03 0.38 ± 0.03 0.38 ± 0.05 0.807
0.864 <0.001
TNF- α (pg/ml) IFN γ (pg/ml)
1.14 ± 0.10 1.18 ± 0.12 1.04 ± 0.09 0.236
0.90 ± 0.06 0.88 ± 0.06 0.86 ± 0.06 0.488
0.838 <0.001
9.24 ± 1.38 9.21 ± 1.11 9.6 ± 1.6
0.819
6.80 ± 0.78 5.76 ± 0.50 9.4 ± 3.0
0.383
0.997 <0.001
Table 3 Overview of satiety, mood, perceived stress and cortisol awakening response data in human subjects. Placebo ( n =48)
B. longum APC1472 ( n =74)
Placebo vs B. longum APC1472
P-value Week 0 – 12
P-value Week 0 – 12
Difference (95% CI)
P- value
η 2
Variable
Week 0
Week 6
Week 12
Week 0
Week 6
Week 12
Questionnaire data Perceived stress (Cohens PSS)
11.2 ± 0.8 10.4 ± 0.8 10.6 ± 0.9 0.422
11.8±0.6
10.6 ± 0.7 10.3 ± 0.8 0.013
− 0.859 ( − 2.7 to 1.0) − 0.089 ( − 0.82 to 0.64) − 0.154 ( − 1.21 to 0.90) − 0.649 ( − 1.60 to 0.30) − 6.514 ( − 17.29 to 4.26)
0.354 0.007
Depression (HADS)
2.45 ± 0.34 2.44 ± 0.35 2.13 ± 0.32 0.315
2.66 ± 0.32 2.57 ± 0.36 2.20 ± 0.32 0.073
0.809 <0.001
Anxiety (HADS)
4.54 ± 0.44 4.40 ± 0.47 4.31 ± 0.54 0.572
4.76 ± 0.41 4.65 ± 0.46 4.35 ± 0.49 0.237
0.772 0.001
Hunger/Satiety
5.00 ± 0.41 4.96 ± 0.41 6.23 ± 0.44 0.026
5.09 ± 0.30 5.86 ± 0.32 5.53 ± 0.30 0.195
0.181 0.015
Cortisol awakening response AUCi (nmol/L)
3.22 ± 7.20 /
9.41 ± 4.37 0.967
1.29 ± 3.26 /
3.55 ± 4.39 0.725
0.233 0.016
AUC (nmol/L) Average (nmol/L)
33.3±2.8 /
37.4 ± 3.8 0.155
45.79 ± 3.92 /
43.5 ± 3.3 0.961 1.12
0.835 0.001
( − 9.5 to 11.8) ( − 2.4 to 2.6)
8.6±4.5
/
11.6 ± 2.0 0.271
11.6±1.0
/
10.5 ± 0.8 0.401 0.09
0.947 <0.001
tively impacts markers of obesity, which may be linked to the ghrelin- ergic effects previously demonstrated [37]. Specifically, we found that in the preclinical mouse model of obesity, the supplementation with B. longum APC1472 significantly reduced fat depots and body weight gain in HFD-fed mice independent of energy intake. Furthermore, B. longum APC1472 significantly reduced circulating leptin levels in HFD-fed
mice, which is in line with the reduction in fat depot size as leptin is released into the bloodstream in proportion to body fat mass [75]. No- tably, circulating levels of leptin were increased in HFD-fed mice com- pared to LFD-fed mice with no alterations in leptin receptor hypothal- amic expression, suggesting no alterations in leptin sensitivity, as has been previously reported in obesity [76]. No changes were observed in
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