RT Journal Article
SR Electronic
T1 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
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e016637
DO 10.1136/bmjopen-2017-016637
VO 7
IS 10
A1 Shuai Huang
A1 Ting-Ting Mo
A1 Tom Norris
A1 Si Sun
A1 Ting Zhang
A1 Ting-Li Han
A1 Angela Rowan
A1 Yin-Yin Xia
A1 Hua Zhang
A1 Hong-Bo Qi
A1 Philip N Baker
YR 2017
UL http://bmjopen.bmj.com/content/7/10/e016637.abstract
AB 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.