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. 2021 Aug 13;22(16):8708. doi: 10.3390/ijms22168708

Table 4.

Studies examining human milk insulin.

Author Year Sample Size (n) Sample Type Sampling Time of the Day (h) Time of
Collection
Preparation Method Intra, Inter Assay (%CV) LOD
(pmol/L)
R (%) Concentration
(pmol/L)
Shehadeh et al. [114] 2003 90 C - - 3, 10 d SM RIA 6.6, - - - d 3: 300.6 ± 207.6, (42–1074)
d 10: 241.2 ± 208.8 (72–1098)
(range)
Ley et al. [82] 2011 34 M pooled milk bank samples - 1–6 mo SM ECLIA - - - 162 ± 64.2
Ley et al. [78] 2012 170 C, M - - 2 d, 3 mo SM ECLIA - - - C, 170 (64,402); M, 52 (34,87)
median (25th,75th percentile)
Fields and Demerath [36] 2012 19 M pre-, mid- and post feed (pooled), 1.5 h after the last feed 8–10 1 mo SM - - - - 954.9 ± 726.5
pg/mL
Whitmore et al. [111] 2012 14 M pre- and post-feed 24 h milk collection 1–6 mo SM ELISA & CMIA -, < 9 CMIA, 9
ELISA, 0.8
Total ELISA, 34.2
CIMA,
100 ± 5
ELISA,
95 ± 4
Total ELISA,
97 ± 8
93.78 ± 6.18
Andreas et al. [46] 2016 120 -
no feeding 1 h prior sampling, pre- and post-feed, protease inhibitors 10:00–13:00 1 wk, 3 mo SM Multiplex assay 3, - 1 - pre-feed, 1 wk, 515.4 (42.4);
post-feed, 1 wk, 439.5 (45.2);
pre-feed, 3 mo, 524.8 (30.9);
post-feed, 3 mo, 456.8 (32.9)
mean (SEM), ng/mL
Nunes et al. [54] 2017 69 C, M - - 1, 2, 30 d SM ELISA - - - SGA, M (n = 12),
109.7 (84.7–156.9);
GDM, M (n = 12),
158.3 (113.2–419.4);
CTL, M (21), 153.5 (92.4–223.6);
median (25–75th percentile)
Young et al. [107] 2017 48 M mid-feed ND 2 wk,
1, 2, 3, 4 mo
SM RIA - - - 2 wk, 109.7 ± 104.2
2 mo, 136.1 ± 86.1
4 mo, 94.4 ± 61.1
Fields et al. [51] 2017 37 M complete feed 8:00–10:00 1, 6 mo SM - - - - 1 mo, 6.5 ± 0.8;
6 mo, 6.0 ± 1.0
Chan et al. [56]
2018 430 M sample collected over 24 h and pooled over 24 h, pooled
together
4 mo SM ELISA 69 586 (340–1013),
pg/mL
Young et al. [88] 2018 41 M fasted,
mid feed
morning 2 wk,
1, 2, 3, 4 mo
SM RIA - - - 2 wk, 93 ± 95.5;
1 mo, 185.4 ± 474;
2 mo, 88.2 ± 55.2;
3 mo, 87.6 ± 57.7;
4 mo, 81.6 ± 52.8
Yu et al. [57] 2018 96 C, M pre- and post-feed for mature milk 3 d, 8:00–9:00
42, 90 d, 14:00–16:00
3, 42, 90 d SM ELISA <4.1, 9.0 3 GDM (n = 48),
d 3, 136.8 (81–307.5);
d 42, 194.2 (78.4–349.3);
d 90, 243.9 (134.9–343.1);
Healthy (n = 48),
d 3, 122.5 (46.1–188.3);
d 42, 169.2 (107.4–240.3;
d 90, 147.7 (80.4–191.1)
Sadr Dadres et al. [58] 2019 135 M 2 h after
feed
10:00–12:00 1 and 3 mo SM ELISA <6, 6 1.44 88–115 1 mo, 178.2 ± 134.4 (26.4–699)
3 mo, 19.2 ± 4.2 (9–28.8)
Grunewald et al. [90] 2019 367 M - - 16–163 d SM ELISA 3.4, 11 - 92.3 ± 14.8 86.5 ± 56.9
Schneider-Worthington et al. [64] 2020 25 M - - 1 mo SM ELISA 4.48, 13.56 - - 60.06 (34.02)
Ellsworth et al. [115] 2020 32 M 2 h after
feed
8:00–10:00 2 wk SM ELISA - - - NW, 100.6 ± 109.02
Ow/Ob, 204.86 ± 147.9
Mank et al. [116] 2021 32 M - - 1–10 mo SM CLIA <6, - - 101–117 (16–1431)
(range)

Data reported as mean ± SD or median (IQR) unless specified. C, colostrum milk; CTL, control; CV %, coefficient variation percentage; CLIA, chemiluminescent immunoassay; CMIA, chemiluminescent microparticle immunoassay ECLIA, electrochemiluminescence immunoassay; ELISA, enzyme-linked immunosorbent assay; GDM, gestational diabetes mellitus; LOD, limit of detection; M, mature milk; mo, month; NW, normal weight; OW/Ob, with overweight/obesity; R%, recovery of analyte percentage; RIA, radioimmunoassay; wk, week.