Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Oct 6;9(4):e001751.
doi: 10.1136/bmjsem-2023-001751. eCollection 2023.

Randomised controlled trial of exercise training during lactation on breast milk composition in breastfeeding people with overweight/obesity: a study protocol for the MILKSHAKE trial

Trine Moholdt  1   2 , Emily Rose Ashby  1 , Karina Hammer Tømmerdal  1 , Maëliss Cynthia Chloé Lemoine  1 , Rebecca Lyng Holm  1 , Pål Sætrom  3 , Ann-Charlotte Iversen  3   4 , Anuradha Ravi  1 , Melanie Rae Simpson  5 , Guro F Giskeødegård  5
Affiliations

Randomised controlled trial of exercise training during lactation on breast milk composition in breastfeeding people with overweight/obesity: a study protocol for the MILKSHAKE trial

Trine Moholdt et al. BMJ Open Sport Exerc Med. .

Erratum in

Abstract

Breast milk from people with overweight/obesity may differ in composition compared with that from normal-weight people. Exercise training can modify breast milk composition in rodent models, with a beneficial impact demonstrated on the offspring's metabolism, but whether these findings translate to humans is unclear. This trial aims to determine the effect of an exercise intervention on breast milk composition and whether an exercise-induced modification of breast milk impacts the infants' growth and body composition. Effect of Exercise Training on Breastmilk Composition is a randomised, controlled trial with two parallel groups, one exercise group and one control group, with a 1:1 allocation. We will include a minimum of 62 exclusively breastfeeding participants, 6 weeks postpartum. The exercise intervention lasts 8 weeks and comprises 25 supervised endurance exercise sessions with moderate or high intensity. The primary outcome measure is the change in the relative concentration of the human milk oligosaccharide 3'sialyllactose in breast milk from baseline at 6 weeks postpartum to the end of the intervention period. Secondary outcomes include breast milk concentrations of other metabolites, cytokines, hormones and microRNA, maternal health outcomes, infant growth, infant gut microbiome and infant circulating microRNA. Maternal and infant outcomes will be measured before, during and after the intervention period, with a follow-up of the infants until they are 24 months old. Trial registration number NCT05488964.

Keywords: body composition; carbohydrates; exercise and/or caloric restriction effects on body weight/composition; nutrition; obesity.

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1. Study design. Overview of the design of the Effect of Exercise Training on Breastmilk Composition randomised controlled trial.
Figure 2
Figure 2. Overview of study visits schedule and procedures.
See this image and copyright information in PMC

References

    1. Di Cesare M, Sorić M, Bovet P, et al. The Epidemiological burden of obesity in childhood: a worldwide epidemic requiring urgent action. BMC Med. 2019;17:212. doi: 10.1186/s12916-019-1449-8. - DOI - PMC - PubMed
    1. Voerman E, Santos S, Patro Golab B, et al. Maternal body mass index, gestational weight gain, and the risk of overweight and obesity across childhood: an individual participant data meta-analysis. PLoS Med. 2019;16:e1002744. doi: 10.1371/journal.pmed.1002744. - DOI - PMC - PubMed
    1. Isganaitis E. Developmental programming of body composition: update on evidence and mechanisms. Curr Diab Rep. 2019;19:60. doi: 10.1007/s11892-019-1170-1. - DOI - PubMed
    1. Mameli C, Mazzantini S, Zuccotti GV. Nutrition in the first 1000 days: the origin of childhood obesity. Int J Environ Res Public Health. 2016;13:838. doi: 10.3390/ijerph13090838. - DOI - PMC - PubMed
    1. Horta BL, Loret de Mola C, Victora CG. Long-term consequences of Breastfeeding on cholesterol, obesity, systolic blood pressure and type 2 diabetes: a systematic review and meta-analysis. Acta Paediatr. 2015;104:30–7. doi: 10.1111/apa.13133. - DOI - PubMed

Associated data