Sixteen-week multicentre randomised controlled trial to study the effect of the consumption of an oat beta-glucan-enriched bread versus a whole-grain wheat bread on glycaemic control among persons with pre-diabetes: a study protocol of the CarbHealth study
Rikard Landberg,
Katja Piotrowski,
Vegard Lysne,
Anette Buyken,
Hanne Rosendahl-Riise,
Jutta Dierkes,
Therese Hjorth,
Alena Schadow,
Ingrid Revheim,
Ulrike Spielau,
Lise M Thomassen,
Klara Meyer,
Anne Rieder,
Paula Varela,
Simon Ballance,
Antje Koerner
Affiliations
Rikard Landberg
5 Department of Biology and Biological Engineering, Chalmers University of Technology, Göteborg, Sweden
Katja Piotrowski
1 Clinical Trial Centre, University of Leipzig, Leipzig, Germany
Vegard Lysne
Centre for nutrition, Department of Clinical Science, University of Bergen, Bergen, Norway
Anette Buyken
3IEL-Nutritional Epidemiology, University of Bonn, DONALD Study, Dortmund, Germany
Hanne Rosendahl-Riise
7 Mohn Nutrition Research Laboratory, Department of Clinical Medicine, University of Bergen, Bergen, Norway
Jutta Dierkes
Department of Clinical Medicine, Centre for Nutrition, Mohn Nutrition Research Laboratory, University of Bergen, Bergen, Norway
Therese Hjorth
Department of Biology and Biological Engineering, Chalmers University of Technology, Goteborg, Sweden
Alena Schadow
Department of Exercise and Health, Paderborn University, Paderborn, Germany
Ingrid Revheim
Department of Clinical Medicine, University of Bergen, Bergen, Norway
Ulrike Spielau
Department of Clinical Medicine, University of Bergen, Bergen, Norway
Lise M Thomassen
Department of Clinical Medicine, University of Bergen, Bergen, Norway
Klara Meyer
Department of Women and Child Health, Centre of Paediatric Research (CPL), Leipzig University, Medical Faculty, Hospital for Children and Adolescents, Leipzig, Germany
Anne Rieder
Norwegian Institute of Food Fisheries and Aquaculture Research, Ås, Norway
Paula Varela
Norwegian Institute of Food Fisheries and Aquaculture Research, Ås, Norway
Simon Ballance
Norwegian Institute of Food Fisheries and Aquaculture Research, Ås, Norway
Antje Koerner
Department of Women and Child Health, Centre of Paediatric Research (CPL), Leipzig University, Medical Faculty, Hospital for Children and Adolescents, Leipzig, Germany
Introduction In 2012, the estimated global prevalence of pre-diabetes was 280 million, and the prevalence is expected to rise to 400 million by 2030. Oat-based foods are a good source of beta-glucans, which have been shown to lower postprandial blood glucose. Studies to evaluate the effectiveness of the long-term intake of beta-glucan-enriched bread as part of a habitual diet among individuals with pre-diabetes are needed. Therefore, we designed a multicentre intervention study in adults with pre-diabetes to investigate the effects of consumption of an oat-derived beta-glucan-enriched bread as part of a normal diet on glycated haemoglobin (HbA1c) in comparison to consumption of whole-grain wheat bread.Methods and analysis The CarbHealth trial is a multicentre double-blind randomised controlled 16-week dietary intervention trial in participants 40–70 years of age with a body mass index of ≥27 kg/m2 and HbA1c of 35–50 mmol/mol. The study is conducted at four universities located in Norway, Sweden and Germany and uses intervention breads specifically designed for the trial by Nofima AS. The aim is to recruit 250 participants. The primary outcome is the difference in HbA1c between the intervention and the control groups. The main analysis will include intervention group, study centre and baseline HbA1c as independent variables in an analysis of covariance model.Ethics and dissemination The study protocol was approved by respective ethical authorities in participating countries. The results of the study will be communicated through publication in international scientific journals and presentations at (inter)national conferences.Trial registration number NCT04994327.
