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Myo-inositol, probiotics and micronutrient supplementation from preconception for glycemia in pregnancy: NiPPeR international multi-center double-blind randomized controlled trial

Myo-inositol, probiotics and micronutrient supplementation from preconception for glycemia in pregnancy: NiPPeR international multi-center double-blind randomized controlled trial
Myo-inositol, probiotics and micronutrient supplementation from preconception for glycemia in pregnancy: NiPPeR international multi-center double-blind randomized controlled trial
Objective: Better preconception metabolic and nutritional health are hypothesized to promote gestational normoglycemia and reduce preterm birth, but evidence supporting improved outcomes with nutritional supplementation starting preconception is limited. Research design and methods: This double-blind randomized controlled trial recruited from the community 1,729 U.K., Singapore, and New Zealand women aged 18-38 years planning conception. We investigated whether a nutritional formulation containing myo-inositol, probiotics, and multiple micronutrients (intervention), compared with a standard micronutrient supplement (control), taken preconception and throughout pregnancy could improve pregnancy outcomes. The primary outcome was combined fasting, 1-h, and 2-h postload glycemia (28 weeks gestation oral glucose tolerance test). Results: Between 2015 and 2017, participants were randomized to control (n = 859) or intervention (n = 870); 585 conceived within 1 year and completed the primary outcome (295 intervention, 290 control). In an intention-to-treat analysis adjusting for site, ethnicity, and preconception glycemia with prespecified P < 0.017 for multiplicity, there were no differences in gestational fasting, 1-h, and 2-h glycemia between groups (β [95% CI] loge mmol/L intervention vs. control -0.004 [-0.018 to 0.011], 0.025 [-0.014 to 0.064], 0.040 [0.004-0.077], respectively). Between the intervention and control groups there were no significant differences in gestational diabetes mellitus (24.8% vs. 22.6%, adjusted risk ratio [aRR] 1.22 [0.92-1.62]), birth weight (adjusted β = 0.05 kg [-0.03 to 0.13]), or gestational age at birth (mean 39.3 vs. 39.2 weeks, adjusted β = 0.20 [-0.06 to 0.46]), but there were fewer preterm births (5.8% vs. 9.2%, aRR 0.43 [0.22-0.82]), adjusting for prespecified covariates. Conclusions: Supplementation with myo-inositol, probiotics, and micronutrients preconception and in pregnancy did not lower gestational glycemia but did reduce preterm birth.
1935-5548
1091-1099
Godfrey, Keith
0931701e-fe2c-44b5-8f0d-ec5c7477a6fd
Barton, Sheila
4f674382-ca0b-44ad-9670-e71a0b134ef0
El-Heis, Sarah
6d7d2e03-3d63-4510-8b7e-fcbe4653db13
Kenealy, Timothy
c032e16b-65a8-4156-bc79-422f6c0e7079
Nield, Heidi
837b180c-0a9e-49ba-bc2e-a899ef761d34
Baker, Philip N.
e1cd37f8-ad89-4ec9-852a-0de07468abab
Chong, Yap-Seng
492de658-aa9e-4b57-95bf-33109f4d2cc5
Cutfield, Wayne
a01589bd-5b82-49fa-89e1-137e6f59e24d
Chan, Shiao-Yng
3c9d8970-2cc4-430a-86a7-96f6029a5293
Godfrey, Keith
0931701e-fe2c-44b5-8f0d-ec5c7477a6fd
Barton, Sheila
4f674382-ca0b-44ad-9670-e71a0b134ef0
El-Heis, Sarah
6d7d2e03-3d63-4510-8b7e-fcbe4653db13
Kenealy, Timothy
c032e16b-65a8-4156-bc79-422f6c0e7079
Nield, Heidi
837b180c-0a9e-49ba-bc2e-a899ef761d34
Baker, Philip N.
e1cd37f8-ad89-4ec9-852a-0de07468abab
Chong, Yap-Seng
492de658-aa9e-4b57-95bf-33109f4d2cc5
Cutfield, Wayne
a01589bd-5b82-49fa-89e1-137e6f59e24d
Chan, Shiao-Yng
3c9d8970-2cc4-430a-86a7-96f6029a5293

Godfrey, Keith, Barton, Sheila, El-Heis, Sarah, Kenealy, Timothy, Nield, Heidi, Baker, Philip N., Chong, Yap-Seng, Cutfield, Wayne and Chan, Shiao-Yng (2021) Myo-inositol, probiotics and micronutrient supplementation from preconception for glycemia in pregnancy: NiPPeR international multi-center double-blind randomized controlled trial. Diabetes Care, 44 (5), 1091-1099. (doi:10.2337/dc20-2515).

Record type: Article

Abstract

Objective: Better preconception metabolic and nutritional health are hypothesized to promote gestational normoglycemia and reduce preterm birth, but evidence supporting improved outcomes with nutritional supplementation starting preconception is limited. Research design and methods: This double-blind randomized controlled trial recruited from the community 1,729 U.K., Singapore, and New Zealand women aged 18-38 years planning conception. We investigated whether a nutritional formulation containing myo-inositol, probiotics, and multiple micronutrients (intervention), compared with a standard micronutrient supplement (control), taken preconception and throughout pregnancy could improve pregnancy outcomes. The primary outcome was combined fasting, 1-h, and 2-h postload glycemia (28 weeks gestation oral glucose tolerance test). Results: Between 2015 and 2017, participants were randomized to control (n = 859) or intervention (n = 870); 585 conceived within 1 year and completed the primary outcome (295 intervention, 290 control). In an intention-to-treat analysis adjusting for site, ethnicity, and preconception glycemia with prespecified P < 0.017 for multiplicity, there were no differences in gestational fasting, 1-h, and 2-h glycemia between groups (β [95% CI] loge mmol/L intervention vs. control -0.004 [-0.018 to 0.011], 0.025 [-0.014 to 0.064], 0.040 [0.004-0.077], respectively). Between the intervention and control groups there were no significant differences in gestational diabetes mellitus (24.8% vs. 22.6%, adjusted risk ratio [aRR] 1.22 [0.92-1.62]), birth weight (adjusted β = 0.05 kg [-0.03 to 0.13]), or gestational age at birth (mean 39.3 vs. 39.2 weeks, adjusted β = 0.20 [-0.06 to 0.46]), but there were fewer preterm births (5.8% vs. 9.2%, aRR 0.43 [0.22-0.82]), adjusting for prespecified covariates. Conclusions: Supplementation with myo-inositol, probiotics, and micronutrients preconception and in pregnancy did not lower gestational glycemia but did reduce preterm birth.

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NiPPeR DC 2nd revision FINAL accepted - Accepted Manuscript
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More information

Accepted/In Press date: 10 February 2021
e-pub ahead of print date: 29 March 2021
Published date: 1 May 2021

Identifiers

Local EPrints ID: 447043
URI: http://eprints.soton.ac.uk/id/eprint/447043
ISSN: 1935-5548
PURE UUID: 1a66233b-2266-434b-8f2b-1084346b0d4b
ORCID for Keith Godfrey: ORCID iD orcid.org/0000-0002-4643-0618
ORCID for Sheila Barton: ORCID iD orcid.org/0000-0003-4963-4242

Catalogue record

Date deposited: 02 Mar 2021 17:31
Last modified: 26 Nov 2021 06:58

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Contributors

Author: Keith Godfrey ORCID iD
Author: Sheila Barton ORCID iD
Author: Sarah El-Heis
Author: Timothy Kenealy
Author: Heidi Nield
Author: Philip N. Baker
Author: Yap-Seng Chong
Author: Wayne Cutfield
Author: Shiao-Yng Chan

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