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. The Auckland KINGS Gastric is a second locality for the KINGS in the Christchurch IBS cohort (ACTRN12621000621819), with site-specific study design and secondary outcomes. In this single arm, open-label, intervention study, we aim to assess the impact of habitual consumption of two Green Kiwifruit daily for 4 weeks on abdominal pain, bowel habits and other gastrointestinal symptoms in individuals with FC/IBS-C; and to evaluate the effects of habitual consumption of Green Kiwifruit on digestive function, gastric motility and emptying, abdominal distension and biomarkers of these physiological effects. Additionally, we hope to investigate the influence of the two Green Kiwifruit intervention on the microbiome and metabolome, and to compare differences between individuals with constipation and healthy controls. The trial will be a maximum of up to 8 weeks in total.
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 8 weeks; 2-week lead-in phase, 4-week intervention phase, and final 2-week follow-up phase.
The 2-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
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 8 weeks; 2-week lead-in phase, 4-week intervention phase, and final 2-week follow-up phase. The 2-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 (end of 2nd 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 physiome during their baseline visit (end of 2nd week of lead-in phase). Participants (constipation group and healthy control group) will consume two Zespri® green kiwifruit per day throughout the 4 weeks intervention. The fruits will be provided by the research team in bulk for the participants to take home. Compliance will be monitored by checklist. 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, fast overnight for 9 hours and provide a fasted blood sample. Participants will receive their reimbursements (gift vouchers) after each visits. Attendance of clinic visits and completion of questionnaire will be assessed to measure the adherence of participants.
Sponsors
University of Otago
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
For inclusion into Constipation Group: Adult with FC or IBS-C (18-65 years) with a BMI between 18 and 35kg/m2. A1. 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 A2. 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. B. For inclusion into Healthy Control group: Adult (18-65 years) with a BMI between 18 and 35kg/m2, not meeting inclusion criteria for Constipation Group and any exclusion criteria.
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 - 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