The CLIMB (Complex Lipids in Mothers and Babies) study: Protocol for a multicentre, three-group, parallel randomised controlled trial to investigate the effect of supplementation of complex lipids in pregnancy, on maternal ganglioside status and subsequent cognitive outcomes in the offspring

Huang, Shuai, Mo, Ting Ting, Norris, Tom, Sun, Si, Zhang, Ting, Han, Ting Li, Rowan, Angela, Xia, Yin Yin, Zhang, Hua, Qi, Hong Bo and Baker, Philip N. (2017) The CLIMB (Complex Lipids in Mothers and Babies) study: Protocol for a multicentre, three-group, parallel randomised controlled trial to investigate the effect of supplementation of complex lipids in pregnancy, on maternal ganglioside status and subsequent cognitive outcomes in the offspring. BMJ Open, 7 (10). ISSN 2044-6055

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Abstract

Introduction: Complex lipids are important constituents of the central nervous system. Studies have shown that supplementation with complex milk lipids (CML) in pregnancy may increase the level of fetal gangliosides (GA), with the potential to improve cognitive outcomes.  Methods and analysis: We aim to recruit approximately 1500 pregnant women in the first trimester (11-14 weeks) and randomise them into one of the three treatment groups: Standard maternal milk formulation, CML-enhanced maternal milk formulation or no maternal milk intervention with standard pregnancy advice (ie, the standard care). Maternal lifestyle and demographic data will be collected throughout the pregnancy, as well as biological samples (eg, blood, hair, urine, buccal smear, cord blood, cord and placenta samples). Data from standard obstetric care recorded in hospital maternity notes (eg, ultrasound reports, results of oral glucose tolerance test and pregnancy outcome data) will also be extracted. Postnatal follow-up will be at 6 weeks and 12 months of age, at which point infant cognitive development will be assessed (Bayley Scales of Infant Development I). Ethics and dissemination This project was approved by the Ethics Committee of Chongqing Medical University. Dissemination of findings will take the form of publications in peer-reviewed journals and presentations at national and international conferences. Trial registration number ChiCTR-IOR-16007700; Pre-results.

Item Type:	Article
Additional Information:	Publisher Copyright: © 2017 Article author(s).
Uncontrolled Keywords:	clinical trials,obstetrics,public health,qualitative research,medicine(all),sdg 3 - good health and well-being ,/dk/atira/pure/subjectarea/asjc/2700
Faculty \ School:	Faculty of Medicine and Health Sciences > Norwich Medical School
UEA Research Groups:	Faculty of Medicine and Health Sciences > Research Centres > Metabolic Health
Related URLs:	http://www.scopus.com/inward/record.url?...
Depositing User:	LivePure Connector
Date Deposited:	02 Mar 2026 17:30
Last Modified:	02 Mar 2026 17:30
URI:	https://ueaeprints.uea.ac.uk/id/eprint/102142
DOI:	10.1136/bmjopen-2017-016637

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