Scientific opinion on the tolerable upper intake level for selenium

View full-text article in PMC

. 2023 Jan 20;21(1):e07704. doi: 10.2903/j.efsa.2023.7704

Reference Study Country	Design N randomised/completed Duration^(a) Recruitment criteria	Subject characteristics at baseline^(b)	Intervention^(b)	Outcomes assessed	Results
Jacobs et al. (2019) Sel/Cel (mOGTT sub‐study) USA	RCT G1, placebo: 914/96* G2, 200 μg Se/day: 910/79* Duration (mean): 2.9 yr Aged 40–80 yr; ≥ 1 colorectal adenomas of diameter ≥ 3 mm; complete removal of all colorectal adenomas within the 6 mo before registration *All participants who remained on the trial near the end and accepted to take part in the mOGTT substudy	Sex (% F): 33.1 Age (yr) G1: 60.9 ± 8.5 G2: 62.3 ± 8.9 BMI (kg/m ² ) G1: 29.8 ± 5.4 G2: 28.5 ± 5.0 Ethnicity (white, %) G1: 95.8 G2: 98.7 Plasma Se (μg/L) G1: 139.7 ± 23.8 G2: 136.8 ± 22.8 Diabetes at baseline (yes, %) G1: 2.1 (N = 2) G2: 1.3 (N = 1)	Selenised yeast (200 μg Se/d) vs placebo Adherence, pill count (%): > 95% in main trial (Thompson et al. 2016).	mOGTT at end of trial; the test was commenced after an overnight fast with 75 g oral dose of glucose, followed by intravenous blood draws at 0, 10, 20, 30, 60, 90, 120 and 180 min.	Glucose (mg/dL, mean ± SD [median (Q1, Q3)]) Fasting G1: 96.6 ± 14.6 [94.0 (87.0, 102.5)] G2: 92.3 ± 12.0 [91.0 (85.0, 101.0)] p = 0.04 at 120 min G1: 132.2 ± 49.8 [122.0 (95.0, 168.0)] G2: 129.4 ± 41.4 [119.0 (98.0, 161.0)] p = 0.70

Reference Study Country

Design N randomised/completed Duration^(a) Recruitment criteria

Subject characteristics at baseline^(b)

Intervention^(b)

Outcomes assessed

Results

Jacobs et al. (2019)

Sel/Cel (mOGTT sub‐study)

USA

RCT

G1, placebo: 914/96*

G2, 200 μg Se/day: 910/79*

Duration (mean): 2.9 yr

Aged 40–80 yr; ≥ 1 colorectal adenomas of diameter ≥ 3 mm; complete removal of all colorectal adenomas within the 6 mo before registration

*All participants who remained on the trial near the end and accepted to take part in the mOGTT substudy

Sex (% F): 33.1

Age (yr)

G1: 60.9 ± 8.5

G2: 62.3 ± 8.9

BMI (kg/m ² )

G1: 29.8 ± 5.4

G2: 28.5 ± 5.0

Ethnicity (white, %)

G1: 95.8

G2: 98.7

Plasma Se (μg/L)

G1: 139.7 ± 23.8

G2: 136.8 ± 22.8

Diabetes at baseline (yes, %)

G1: 2.1 (N = 2)

G2: 1.3 (N = 1)

Selenised yeast (200 μg Se/d) vs placebo

Adherence, pill count (%): > 95% in main trial (Thompson et al. 2016).

mOGTT at end of trial; the

test was commenced

after an overnight fast with 75 g oral dose of glucose,

followed by intravenous blood draws at 0, 10, 20, 30,

60, 90, 120 and 180 min.

Glucose (mg/dL, mean ± SD [median (Q1, Q3)])

Fasting

G1: 96.6 ± 14.6 [94.0 (87.0, 102.5)]

G2: 92.3 ± 12.0 [91.0 (85.0, 101.0)]

p = 0.04

at 120 min

G1: 132.2 ± 49.8 [122.0 (95.0, 168.0)]

G2: 129.4 ± 41.4 [119.0 (98.0, 161.0)]

p = 0.70

BMI: body mass index; d: day; F: females; Gx: group x; mOGTT: modified oral glucose tolerance test; N: number; Qx: quartile x; RCT: randomised controlled trial; SD: standard deviation; Se: selenium; Sel/Cel: Selenium and Celecoxib trial; USA: United states of America; yr: year.

(a) Duration = duration of the treatment phase, unless specified otherwise.

(b): Mean ± SD, unless specified otherwise.