2014
DOI: 10.4172/2167-0870.1000178
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Two Randomized Cross-Over Trials Assessing the Impact of Dietary Gluten or Wholegrain on the Gut Microbiome and Host Metabolic Health

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Cited by 16 publications
(18 citation statements)
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“…The study protocol, randomisation, inclusion and exclusion criteria, and study products in the clinical studies that intervened with a whole grain-rich diet ( https://clinicaltrials.gov , ID-no: NCT01731366) or a low-gluten diet ( https://clinicaltrials.gov , ID-no: NCT01719913) are described previously 22 . Both studies were performed in accordance with relevant regulations and written informed consent was obtained from all participants.…”
Section: Methodsmentioning
confidence: 99%
See 1 more Smart Citation
“…The study protocol, randomisation, inclusion and exclusion criteria, and study products in the clinical studies that intervened with a whole grain-rich diet ( https://clinicaltrials.gov , ID-no: NCT01731366) or a low-gluten diet ( https://clinicaltrials.gov , ID-no: NCT01719913) are described previously 22 . Both studies were performed in accordance with relevant regulations and written informed consent was obtained from all participants.…”
Section: Methodsmentioning
confidence: 99%
“…We previously investigated the impact of 8 weeks dietary interventions on human metabolic health outcomes in two Danish randomized cross-over trials with a whole grain-rich diet or low-gluten diet, associated with a beneficial and non-beneficial impact on metabolic health, respectively 22 24 , and identified weight loss as a response to each of the interventions relative to a refined grain diet 25 , 26 . It has however been argued that no single dietary strategy would be appropriate for all individuals and that certain biomarkers can be important in relation to predisposition for weight loss 7 .…”
Section: Introductionmentioning
confidence: 99%
“…Importantly, participants had to meet similar inclusion and exclusion criteria in both trials and the different modes of interventions in the two studies are irrelevant for the present study, which exclusively was based on analyses of data obtained at baseline prior to start of the specific interventions [15]. The trials were registered at www.clinicaltrials.gov (NCT01719913 and NCT01731366) and were conducted in accordance with the Helsinki declaration II and endorsed by the Danish Data Protection Agency (2007-54-0269) and The Ethical Committee of the Capital Region of Denmark approved the trials (H-2-2012-065).…”
Section: Methodsmentioning
confidence: 99%
“…This study included cross-sectional baseline data from six human intervention trials: 3G, OPUS, DIOGENES, RIGHT, MyNewGut (MNG), and PROKA (1015). The studies were registered at http://www.clinicaltrials.gov; 3G (NCT01719913 and NCT01731366); SHOPUS (NCT01195610); DIOGENES (NCT00390637); RIGHT (NCT02358122); MNG: (NCT02215343); PROKA (NCT01561131) and approved by the Research Ethics Committees of the Capital Region of Denmark in accordance with Helsinki Declaration 3G (H-2-2012-064 and H-2-2012-065); SHOPUS (H-3-2010-058); RIGHT (H-1-2014-062); MNG (H-4-2014-052); and PROKA (H-2-2011-145) or the local ethical committees in the respective countries (16).…”
Section: Methodsmentioning
confidence: 99%