None listed
Conditions
Brief summary
Gastrointestinal discomfort, including constipation, is a common condition throughout the world, which often leads to a reduction in the quality of life. The prevelance of constipation is reported to affect around 15% of adults in the western world. The consumption of green kiwifruit is recognised to assist with the relief of constipation and provide potential relief of gastrointestinal symptoms. A more recently commerecialised cultivar marketed as SunGold may also have a similar effect. The aim of this study is to examine the effect of daily consumption of three SunGold kiwifruit in individuals who suffer from functional constipation or irritable bowel syndrome with constipation to determine if kiwifruit can improve bowel regularity, digestive discomfort, digestive health and function and gut health. The effect of the kiwifruit will be compared with psyllium (Metamucil(Registered Trademark)), a bowel bulking agent that has been shown to be an effective treatment for constipation. The trial is a randomised, single-blinded cross-over study where individuals will consume either 3 SunGold kiwifruit daily for four weeks or 2.5 teaspoons of Metamucil(Registered Trademark) powder for four weeks. There will be a four week washout period and then the participants will swap over treatments for a further four weeks. The trial will start and finish with a 2 week washout period. Participants will be asked to complete a daily diary to record bowel movement and general wellbeing during the study. Faecal samples and blood will be collected at the beginning of the trial and at the end of each treatment period. Participants will also be asked to complete at questionnaire relating to bowel health at these points.
Interventions
The study duration is a total of 16 weeks; 2-week lead in, 4-week intervention, 4-week washout, 4-week intervention, and final 2-week follow up. The cross-over design will be completed using the kiwifruit intervention (3 SunGold kiwifruit per day (Actinidia chinensis 'Zesy002)), compared to a positive control intervention of psyllium (Two and a half teaspoons of Metamucil(Registered trademark) per day providing 5.0g fibre). The kiwifruit and Metamucil (Registered trademark) can be consumed in tw
The study duration is a total of 16 weeks; 2-week lead in, 4-week intervention, 4-week washout, 4-week intervention, and final 2-week follow up. The cross-over design will be completed using the kiwifruit intervention (3 SunGold kiwifruit per day (Actinidia chinensis 'Zesy002)), compared to a positive control intervention of psyllium (Two and a half teaspoons of Metamucil(Registered trademark) per day providing 5.0g fibre). The kiwifruit and Metamucil (Registered trademark) can be consumed in two doses, preferably one dose in the morning and one dose at night. There is no restriction as to what other foods are consumed with them. Adherence to the treatments is measured by a daily diary and food diaries at the end of each treatment. The lead-in period requires individuals to stop taking laxatives and kiwifruit.
Sponsors
The New Zealand Institute for Plant & Food Research
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Functionally Constipated Group and Irritable Bowel Sydrome with constipation group: Adult (18-65 years), BMI 18-25, Both male and female (females will be required to declare stage of menstrual cycle during different trial stages), Presence of Functional Constipation or Irritable Bowel Syndrome according to ROME III diagnostic criteria.
Exclusion criteria
1. Alarm features associated with bowel habit (recent changes in bowel habit (<3 months), rectal bleeding, weight loss, blood in stools, bleeding haemorrhoids, family history of Gastrointestinal (GI) cancer or Irritable Bowel Disease (IBD). 2. Chronic disease (cardiovascular, cancer, renal failure, previous GI surgery (not including appendectomy or cholecystectomy), neurological conditions (e.g. stroke, spinal chord injury, multiple sclerosis) 3. Fasting blood glucose of 6.0 mmol/l or greater. Participants will be screened during recruitment. 4. Participants with diagnosed and stable conditions requiring the use of selective serotonin uptake inhibitors, triglycerides, opiates or anti-inflammatories will only be permitted into the trial on condition that the medication has been in use continually and the condition has been stable for > 3 months. Similarly those with stable and controlled diabetes for > 3 months will also be permitted to take part in the study. 5. Women who are pregnant, breastfeeding or planning a pregnancy in the 3 months post selection will be excluded. 6. Potential participants with known kiwifruit or latex allergy will be excluded.
Outcome results
None listed