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The hypothesis was that WP, when administered as a pre-meal 30 min before breakfast daily, lowers glycaemic variability (primary outcome: CV%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      In a double-blinded, randomised, placebo-controlled, parallel trial, 62 women with GDM were randomised to receive 20 g WP isolate\/day or placebo 30 min before breakfast throughout the third trimester. Participants were randomly assigned (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/www.randomiser.org\" ext-link-type=\"uri\">www.randomiser.org<\/jats:ext-link>\n                      ) to WP or placebo using a computer-generated list. Allocation was concealed with sealed strips. Participants, caregivers, investigators and outcome assessors were masked, except the dietitian providing dietary guidance. Eligibility criteria included GDM, normotension and age \u226518 years. Exclusion criteria included special dietary regimens \u22651 month, daily protein supplements, food allergies, glucose-metabolism-affecting drugs, twin pregnancies, polycystic ovary syndrome, severe comorbidity, hyperemesis or non-breakfast eaters. The study included laboratory visits, home-based measurements under controlled-living and free-living conditions during the early and late third trimester, and follow-up at delivery. Glucose levels were assessed using continuous glucose monitoring.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 29 women were randomised to placebo and 33 were randomised to WP, with 25 in the placebo group and 30 women in the WP group completing the study. In the WP group, the 1 h postprandial glucose following breakfast was \u221220% (95% CI \u221228%, \u221211%) lower in the early and \u221215% (95% CI \u221224%, \u22125%) lower in the late third trimester compared with the placebo group under controlled conditions. Similarly, the 1 h postprandial glucose was \u221214% (95% CI \u221223%, \u22124%) lower in the early and \u22128% (95% CI \u221218%, 3%) lower in the late third trimester under free-living conditions. Glycaemic variability was lower in the WP group under controlled-living conditions. The mean amplitude of glycaemic excursions (MAGE) was lower during both the early and late third trimester, and the SD and CV% were lower during the early third trimester (all\n                      <jats:italic>p<\/jats:italic>\n                      &lt;0.05). Time in range (proportion of time spent with glucose levels 3.5\u20137.8 mmol\/l) was lower during free-living in the late third trimester (\n                      <jats:italic>p<\/jats:italic>\n                      =0.05).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions\/interpretation<\/jats:title>\n                    <jats:p>Pre-meal WP improves glycaemic management and reduces glucose variability in women with GDM under controlled-living and free-living conditions. Future research should evaluate whether WP can delay or prevent pharmacological treatments such as insulin initiation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>ClinicalTrials.gov NCT04767880<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Funding<\/jats:title>\n                    <jats:p>Department of Clinical Medicine, Aarhus University and Arla Foods Ingredients Group P\/S (Agr-2020\u2013731\u201312107).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Graphical Abstract<\/jats:title>\n                  <\/jats:sec>","DOI":"10.1007\/s00125-025-06587-0","type":"journal-article","created":{"date-parts":[[2025,11,7]],"date-time":"2025-11-07T22:12:54Z","timestamp":1762553574000},"page":"350-363","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Once-daily supplementation with pre-meal whey protein lowers breakfast postprandial glucose levels in women with GDM throughout the third trimester: a randomised, controlled, clinical trial"],"prefix":"10.1007","volume":"69","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0225-8809","authenticated-orcid":false,"given":"Stine","family":"Smedegaard","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9938-2181","authenticated-orcid":false,"given":"Nikolaj","family":"Rittig","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Per G.","family":"Ovesen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-5479-6047","authenticated-orcid":false,"given":"Louise B.","family":"Suder","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-8595-7265","authenticated-orcid":false,"given":"Janni H.","family":"Knudsen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lise H.","family":"Brunsgaard","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2234-7780","authenticated-orcid":false,"given":"Ulla","family":"Kampmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,11,7]]},"reference":[{"issue":"9","key":"6587_CR1","doi-asserted-by":"publisher","first-page":"469","DOI":"10.1016\/j.jogoh.2018.08.003","volume":"47","author":"J Huet","year":"2018","unstructured":"Huet J, Beucher G, Rod A, Morello R, Dreyfus M (2018) Joint impact of gestational diabetes and obesity on perinatal outcomes. 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Buus, E. Hornemann, H. Fjeldsted and M. Flinck, Steno\/Medical Aarhus Research Laboratory, Aarhus University Hospital, for their invaluable assistance during study days and their technical expertise in the laboratory. Special thanks go to C. W. Poulsen, Department of Obstetrics and Gynecology, Aarhus University Hospital, for her guidance on nutritional regimens and the staff at the AUH Kitchen for their support in tailoring meal plans and preparing food packages. We are also deeply appreciative of the laboratory technicians from the Department of Clinical Biochemistry, Aarhus University Hospital, for their expertise in collecting and processing cord blood samples. Additionally, we acknowledge the midwives at Aarhus University Hospital for their crucial role in cord blood sampling after delivery. Special thanks to the staff at the outpatient clinics, Aarhus University Hospital, the Regional Hospitals G\u00f8dstrup, Viborg, Horsens and Randers, for their support in recruiting participants. Results of this study were presented at the annual meeting of the Danish Endocrine Society (DES) on 28 February 2025.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Acknowledgements"}},{"value":"Data are available on request from the corresponding author.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data availability"}},{"value":"SS received funding from the Department of Clinical Medicine, Aarhus University. Arla Foods Ingredients Group P\/S (AFI) provided financial support for operational expenses (Agr-2020-731-12107) and supplied the WP and placebo pre-meals. The funders were not involved in the design of the study; the collection, analysis, and interpretation of data; writing the report; and did not impose any restrictions regarding the publication of the report.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"LHB is a nutrition research scientist at Arla Foods Ingredients Group P\/S. Arla Foods Ingredients Group P\/S did not influence the study\u2019s design, execution, data analysis, interpretation or decision to publish. UK received funding from the Novo Nordisk Foundation and NR received funding from the Novo Nordisk Foundation and Arla Food for Health for other studies. The authors declare that there are no other relationships or activities that might bias, or be perceived to bias, their work.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authors\u2019 relationships and activities"}},{"value":"SS, NR, PO and UK conceptualised and designed the study with input from LHB. LBS was responsible for developing the food survey and meal plans. JK provided guidance and collaborated closely with participants to adjust meal plans. JK and SS acquired the data. SS conducted the study and performed the statistical analyses. SS, NR, PO and UK contributed to data interpretation. SS drafted the manuscript, which all authors reviewed critically for important intellectual content. All authors approved the final version to be published. SS and UK are the guarantors of this work and accept full responsibility for the work and the conduct of the study, had access to the data, and controlled the decision to publish.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Contribution statement"}}]}}