None listed
Conditions
Brief summary
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.
Interventions
The main intervention will consist of two Zespri™ green kiwifruit per day, which will be eaten orally without the skin for 4 weeks.
The study duration is a nominal total of 9 weeks; 3-week lead-in phase, 4-week intervention phase, and final 2-week follow-up phase.
The 3-weeks lead-in phase requires participants to record their bowel motion on a developed app every day (until study completion); complete a questionnaire in regards to their socioeconomic status and general wellbeing, complete a no
The main intervention will consist of two Zespri™ green kiwifruit per day, which will be eaten orally without the skin for 4 weeks. The study duration is a nominal total of 9 weeks; 3-week lead-in phase, 4-week intervention phase, and final 2-week follow-up phase. The 3-weeks lead-in phase requires participants to record their bowel motion on a developed app every day (until study completion); complete a questionnaire in regards to their socioeconomic status and general wellbeing, complete a non-consecutive 3-day food diary and a fibre-specific food frequency questionnaire (2nd week of lead-in phase). Participants will consume a provided evening standardised meal, provide a faecal sample and fast overnight for 9 hours one day prior to their baseline visit (3rd week of lead-in phase). Participants will provide a blood sample, complete a set of questionnaires in regards to their mental and physical health, general well-being, and clinical variables, undergo Magnetic Resonance Imaging (MRI), ingest diagnostic devices (Atmo and Smart Pill) in capsule form, and blue food dye to measure whole gut transit during their baseline visit (3rd week of lead-in phase). Participants with FC and IBS-C will be randomised by using randomised permuted blocks, block size 4 to consume either two Zespri® green kiwifruit or 25g of maltodextrin (energy matched) per day throughout the 4 weeks intervention. The fruits will be provided by the research team in bulk. Selected participants will take the interventions home. Leftover fruit will be counted to measure adherence. Participants will repeat all of the aforementioned baseline visit procedures before and on their post-intervention visit. Prior to the follow up visit, participants will again complete the same set of questionnaires, provide a faecal sample and fast overnight for 9 hours. Participants will provide a blood sample and receive their reimbursement during their follow up visit. Attendance of clinic visits and completion of questionnaire will be assessed to measure the adherence of participants. The data generated with the questionnaires will be correlated to the data of the biological samples, such as the abundance of metabolites (including neurotransmitters), population and genetic composition of the microbiota as well as physiome data from MRI, blue food dye, Atmo, and Smartpill capsules, to determine the differences between the two groups.
Sponsors
Nicole Roy
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Adult with FC or IBS-C (18-65 years) with a BMI between 18 and 35kg/m2. A. The FC participants will be selected based on the following criteria: Presence of FC according to Rome IV Diagnostic Criteria (fulfilled for the last three months with symptom onset at least six months prior to diagnosis): 1. Must include two or more of the following: - Straining during more than 25% of defecations - Lumpy or hard stools during more than 25% of defecations - Sensation of incomplete evacuation for more than 25% of defecations - Sensation of anorectal obstructions/blockage for more than 25% of defecations - Manual manoeuvres to facilitate more than 25% of defecations (e.g. digital evacuation, support of the pelvic floor) - Fewer than three complete spontaneous bowel movements per week 2. Loose stools are rarely present without the use of laxatives 3. Insufficient criteria for irritable bowel syndrome The participants with mild IBS-C will be selected based on the following Rome IV Diagnostic Criteria (fulfilled for the last three months with symptom onset at least six months prior to diagnosis): 1. Recurrent abdominal pain, on average, at least one day per week in the last three months, associated with two or more of the following: - Related to defecation - Associated with a change in frequency of stool - Associated with a change in form (appearance) of stool 2. More than 25% of bowel movements with Bristol Stool form types 1 or 2 and less than 25% of Bowel movements of types 6 or 7.
Exclusion criteria
- Inability to give informed consent - Pregnancy, breastfeeding or planning a pregnancy in the three months post-selection (study time frame) - Alarm features associated with bowel habits, such as recent changes in bowel habits (onset less than three months), rectal bleeding, sudden weight loss, occult blood in stool, anaemia, anal fissures, bleeding haemorrhoids, and family history of gastrointestinal cancer at a young age or Irritable Bowel Disease (IBD) - Known significant gastrointestinal disorder and disease other than IBS-C, diverticulitis, coeliac disease, IBS-D or mixed IBS, or previous bowel resection. - Known systemic disease that could influence the gut directly or through medication use (e.g. diabetes, opiate or NSAID use) - Chronic disease such as cardiovascular, cancer, renal failure, previous gastrointestinal surgery other than cholecystectomy or appendectomy, neurological conditions such as multiple sclerosis, spinal cord injury, or stroke - Fasting blood glucose equals to or more than 6.0 mmol/l - Known kiwifruit or latex allergy - Inability to swallow pills - Inability to access MRI machines such as presence of pacemakers or cochlear implants - Laxative use and inability or unwillingness to stop laxative use for the seven days before sample collections. - An IBS Severity Index score of over 300. - Indication of inability to comply with the study procedures
Outcome results
None listed