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Decentralized clinical trials are better for the participants and for the planet: the case study of a double-blind randomized controlled trial in Singapore (PROMOTE study).
Front Public Health
January 2025
Clinical Research Unit, Nestlé Research, Société des Produits Nestlé S.A., Lausanne, Switzerland.
Introduction: Novel technologies have enabled the decentralization of many aspects of clinical trials, but little research has been done on the impact of these changes on the participant experience, trial operations, or the environment.
Methods: A fully decentralized clinical trial conducted in Singapore is used as a case study to evaluate the operational outcomes, environmental impact (via life cycle assessment), and participants experience (qualitative interviews) of the decentralized model compared to a traditional study with in-person visits.
Results: The decentralized study achieved high participant retention rates (97%) and high completion rates for clinical data, even for biological samples.
Diversity of complementary diet and early food allergy risk.
Pediatr Allergy Immunol
January 2025
Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden.
Introduction: Diet diversity (DD) in infancy may be protective for early food allergy (FA) but there is limited knowledge about how DD incorporating consumption frequency influences FA risk.
Methods: Three measures of DD were investigated in 2060 infants at 6 and/or at 9 months of age within the NorthPop Birth Cohort Study: a weighted DD score based on intake frequency, the number of introduced foods, and the number of introduced allergenic foods. In multivariable logistic regression models based on directed acyclic graphs, associations to parentally reported physician-diagnosed FA at age 9 and 18 months were estimated, including sensitivity and stratified analyses.
Zinc absorption from maize-based meals enriched with edible house crickets: a randomized crossover stable-isotope study in Kenyan pre-school children.
Nat Commun
January 2025
Division of Human Nutrition and Health, Wageningen University & Research, Wageningen, the Netherlands.
Edible insects have been proposed as a novel and sustainable source of protein and other essential nutrients for human consumption but nutrient absorption efficiency is still uncertain. We investigated zinc absorption from house crickets (Acheta domesticus) in a single-center and single-blinded cross-over study with children aged 24-36 months old in Kenya from September-November 2021. For this, children were randomized to consume two different experimental meals labeled with stable isotopes of zinc (Zn) at two different days, separated by a wash-out period of one month.
View Article and Find Full Text PDFPatient-reported outcomes in sarcopenia: An ICFSR task force report.
J Frailty Aging
February 2025
Department of Human Neuroscience, Sapienza University, Rome, Italy; National Center for Disease Prevention and Health Promotion, Italian National Institute of Health, Rome, Italy; Aging Research Center, Department of Neurobiology, Care Sciences, and Society, Karolinska Institute and Stockholm University, Stockholm, Sweden.
The International Conference on Frailty and Sarcopenia Research (ICFSR) Task Force convened in March 2024 to address patient-reported outcomes measures (PROMs) in the field of sarcopenia. PROMs are crucial to enhance healthcare services at both individual and societal levels. PROMs complement objective outcome measures by capturing insights that patients are best suited to judge.
View Article and Find Full Text PDFCardiometabolic benefits of a non-industrialized-type diet are linked to gut microbiome modulation.
Cell
January 2025
Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AB T6G 2E1, Canada; APC Microbiome Ireland, University College Cork, Cork T12 YT20, Munster, Ireland; School of Microbiology, University College Cork, Cork T12 YT20, Munster, Ireland; Department of Medicine, University College Cork, Cork T12 YT20, Munster, Ireland; Department of Biological Sciences, University of Alberta, Edmonton, AB T6G 2E1, Canada. Electronic address:
Industrialization adversely affects the gut microbiome and predisposes individuals to chronic non-communicable diseases. We tested a microbiome restoration strategy comprising a diet that recapitulated key characteristics of non-industrialized dietary patterns (restore diet) and a bacterium rarely found in industrialized microbiomes (Limosilactobacillus reuteri) in a randomized controlled feeding trial in healthy Canadian adults. The restore diet, despite reducing gut microbiome diversity, enhanced the persistence of L.
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