TY - JOUR
T1 - Effect of selenium supplementation on changes in HbA1c
T2 - Results from a multiple-dose, randomized controlled trial
AU - Stranges, Saverio
AU - Rayman, Margaret P.
AU - Winther, Kristian H.
AU - Guallar, Eliseo
AU - Cold, Søren
AU - Pastor-Barriuso, Roberto
N1 - Funding Information:
information This work was supported by: the Danish Cancer Society; The Research Foundation of the County of Funen; Cypress Systems Inc.; The Danish Veterinary and Food Administration; The Council of Consultant Physicians, Odense University Hospital; The Clinical Experimental Research Foundation at Department of Oncology, Odense University Hospital; K. A. Rohde's Foundation; Dagmar Marshall's Foundation. The Luxembourg Institute of Health provided an internal grant to S. S. for HbA1c measurements. The funders had no role in the design or conduct of the study; collection, management, analysis and interpretation of the data; preparation, review or approval of the manuscript; and decision to submit the manuscript for publication.Pharma Nord ApS, Vejle, Denmark provided the selenium and placebo tablets. None declared. S. S., M. P. R. and S. C. designed the research; K. H. W., S. C. and R. P.-B. conducted research and analysed data; R. P.-B. performed statistical analysis; S. S., M. P. R. and R. P.-B. wrote the paper with help from K. H. W. and E. G.; S. S. (guarantor) and M. P. R. had primary responsibility for the final content. All the authors read and approved the final manuscript.
Funding Information:
This work was supported by: the Danish Cancer Society; The Research Foundation of the County of Funen; Cypress Systems Inc.; The Danish Veterinary and Food Administration; The Council of Consultant Physicians, Odense University Hospital; The Clinical Experimental Research Foundation at Department of Oncology, Odense University Hospital; K. A. Rohde's Foundation; Dagmar Marshall's Foundation. The Luxembourg Institute of Health provided an internal grant to S. S. for HbA1c measurements. The funders had no role in the design or conduct of the study; collection, management, analysis and interpretation of the data; preparation, review or approval of the manuscript; and decision to submit the manuscript for publication.
Publisher Copyright:
© 2018 John Wiley & Sons Ltd
PY - 2019/3
Y1 - 2019/3
N2 - Aim: To investigate the effect of selenium supplementation at different dose levels on changes in HbA1c after 6 months and 2 years in a population of low selenium status. Materials and Methods: The Denmark PRECISE study was a single-centre, randomized, double-blinded, placebo-controlled, multi-arm, parallel clinical trial with four groups. In total, 491 volunteers aged 60 to 74 years were randomly assigned to treatment with 100, 200 or 300 μg selenium/day as selenium-enriched yeast or placebo-yeast. HbA1c measurements were available for 489 participants at baseline, 435 at 6 months, and 369 after 2 years of selenium supplementation. Analyses were performed by intention to treat. Results: The mean (SD) age, plasma-selenium concentration, and blood HbA1c at baseline were 66.1 (4.1) years, 86.5 (16.3) ng/g and 36.6 (7.0) mmol/mol, respectively. During the initial 6-month intervention period, mean HbA1c (95% CI) decreased by 1.5 (−2.8 to −0.2) mmol/mol for 100 μg/d of selenium supplementation and by 0.7 (−2.0 to 0.6) mmol/mol for the 200 and 300 μg/d groups compared with placebo (P = 0.16 for homogeneity of changes across the four groups). After 2 years of selenium supplementation, HbA1c had decreased significantly in all treatment groups, with no difference between active treatment and placebo. Conclusions: Selenium supplementation in an elderly European population of low selenium status did not significantly affect HbA1c levels after 2 years. Our findings corroborate a possible U-shaped response of selenium supplementation on glucose metabolism.
AB - Aim: To investigate the effect of selenium supplementation at different dose levels on changes in HbA1c after 6 months and 2 years in a population of low selenium status. Materials and Methods: The Denmark PRECISE study was a single-centre, randomized, double-blinded, placebo-controlled, multi-arm, parallel clinical trial with four groups. In total, 491 volunteers aged 60 to 74 years were randomly assigned to treatment with 100, 200 or 300 μg selenium/day as selenium-enriched yeast or placebo-yeast. HbA1c measurements were available for 489 participants at baseline, 435 at 6 months, and 369 after 2 years of selenium supplementation. Analyses were performed by intention to treat. Results: The mean (SD) age, plasma-selenium concentration, and blood HbA1c at baseline were 66.1 (4.1) years, 86.5 (16.3) ng/g and 36.6 (7.0) mmol/mol, respectively. During the initial 6-month intervention period, mean HbA1c (95% CI) decreased by 1.5 (−2.8 to −0.2) mmol/mol for 100 μg/d of selenium supplementation and by 0.7 (−2.0 to 0.6) mmol/mol for the 200 and 300 μg/d groups compared with placebo (P = 0.16 for homogeneity of changes across the four groups). After 2 years of selenium supplementation, HbA1c had decreased significantly in all treatment groups, with no difference between active treatment and placebo. Conclusions: Selenium supplementation in an elderly European population of low selenium status did not significantly affect HbA1c levels after 2 years. Our findings corroborate a possible U-shaped response of selenium supplementation on glucose metabolism.
KW - HbA1c
KW - diabetes
KW - randomized controlled trial
KW - selenium
KW - selenium dose
KW - selenium toxicity
UR - http://www.scopus.com/inward/record.url?scp=85055714348&partnerID=8YFLogxK
U2 - 10.1111/dom.13549
DO - 10.1111/dom.13549
M3 - Article
C2 - 30280459
AN - SCOPUS:85055714348
SN - 1462-8902
VL - 21
SP - 541
EP - 549
JO - Diabetes, Obesity and Metabolism
JF - Diabetes, Obesity and Metabolism
IS - 3
ER -