This metadata record and it's attached files make statements about the kinds of data collected as part of this research, and set out policies for governance of that data, now and in the future.
Description: The Kiwifruit Ingestion to Normalise Gut Symptoms (KINGS) study was launched to understand more about the clinical, psychological, biological, and dietary changes in individuals with Functional Constipation (FC) or Constipation-Predominant Irritable Bowel Syndrome (IBS/C). We believe that the approach used in this study can help generate new knowledge beyond that already reported for the consumption of green kiwifruit. In this single-blinded, negative-controlled, randomised, parallel study, we aim to find differences in abdominal comfort between individuals with FC or IBS-C by ingesting either two Green Kiwifruit daily or Maltodextrin over the course of 4 weeks. The trial will be a maximum of up to 9 weeks in total. We hypothesise that the habitual consumption of two green kiwifruit will improve abdominal pain as measured by the GSRS ratings, other gut symptoms, bowel habits, fatigue, anxiety, depression, and total intestinal transit in individuals with FC and IBS-C. Additionally, we hope to find differences in the microbiome and metabolome in individuals consuming kiwifruit compared to control.
Publisher
University of AucklandTemporal coverage: start
2021-01-01Temporal coverage: end
2024-01-01HVN Project / Programme Name
HVN KINGS GUTData access requirements
Individual data is not available to the public. It would be a breach of data security.Principal investigator organisation
University of OtagoCollaborating researchers and affiliations
Principal Investigators:
Professor Richard Gearry, Department of Medicine, University of Otago,Gastrointestinal Unit for Translational Studies, University of Otago, Christchurch
Professor Nicole Roy, Department of Human Nutrition, University of Otago, Dunedin
Research coordinator:
Dr. Simone Bayer (University of Otago, Christchurch)
Project Team:
Professor Warren McNabb (Riddet Institute)
Dr. Karl Fraser (AgResearch)
Dr. Diana Cabrera (AgResearch)
Dr. Wayne Young (AgResearch)
Dr. Jane Mullaney (Riddet Institute, AgResearch)
Professor Robin Spiller (National Institute of Health Research (NIHR), Nottingham Biomedical Research Centre)
Professor Luca Marciani (National Institute of Health Research (NIHR), Nottingham Biomedical Research Centre)
Dr. Caroline Hoad (National Institute of Health Research (NIHR), Nottingham Biomedical Research Centre)
Dr. Janine Cooney (Plant and Food Research)
Dr. Catrin Guenther (Plant and Food Research)
Dr. Tania Trower (Plant and Food Research)
Dr. Olivier Gasser (Malaghan Institute of Medical Research)
Dr. Jeffry Tang (Malaghan Institute of Medical Research)
Dr. Amber Milan (Liggins Institute)
Dr. Catherine Wall (University of Otago, Christchurch)
Dr. Meika Foster (Riddet Institute, Edible Research)
Dr Kyle Berean (ATMO Bioscience, Melbourne)
Prof. Chris Frampton (University of Otago, Christchurch)
Jasjot Maggo PhD fellow (University of Otago, Christchurch)
Hwei Min Ng PhD fellow (University of Otago, Christchurch)Data description
Outcomes of the study and associated data
Primary outcome
an improvement of digestive comfort as indicated by statistically significant abdominal pain relief as measured by the Gastrointestinal Symptom Rating Scale (GSRS)
Associated data: GSRS Questionnaire
Secondary outcomes
1. Clinical outcomes
- An increase in complete spontaneous bowel movement (CSBM) in FC/IBS-C with the GrKF intervention
- Improved scores of validated patient-reported outcomes (PROs)
Associated data: Daily bowel habit diary, ROME IV Diagnostic Questionnaire, Patient Reported Outcomes Measurement Information System (PROMIS gastrointestinal, anxiety and depression), Irritable Bowel Syndrome - Quality of Life survey, World Health Organisation - Five question Well-Being Index, Warwick-Edinburgh Mental Wellbeing Scales, Structured Assessment of Gastrointestinal Symptoms Questionnaire, Multidimensional Fatigue Inventory
2. Physiome outcomes
Changes in total GI transit time, faecal water content, colonic gas content and composition as measured by MRI, blue food dye, Atmo gas-sensing capsule, and SmartPill
Associated data: MRI, Blue dye, Smart Pill, ATMO gas-sensing capsule
3. Systems biology outcomes
Changes in faecal metabolome, metagenome, bile and organic acid production plasma metabolome and neurotransmitters, and immune markers after intervention.
Associated data: Plasma metabolome, plasma neurotransmitters, blood and plasma immune markers (cytokine, phenotyping, peripheral blood mononuclear cells (PBMCs), faecal metagenome, faecal metabolome, faecal organic and bile acids
4. Dietary outcomes
Changes in macro and micronutrients, change in fibre intake.
Associated data: Fibre-specific Food Frequency Questionnaire, three-day food diary
Other data: Participant Screening Questionnaire, Participant blood screen, Economic Living Standard Index short form – ELSISF, Modified Hunter New England Health Survey – ModHNES (Enrolment)Principal investigator contact email
richard.gearry@otago.ac.nz
nicole.roy@otago.ac.nz
