None listed
Conditions
Brief summary
Constipation is a common problem affecting up to 20% of the World’s population. Laxative treatment for this condition is not without side effects and currently, there is a need for natural and safe alternatives. The consumption of Kiwifruit is frequently used to treat constipation and digestive discomfort in New Zealand. Clinical trials in this area are limited but some have shown significant improvements in digestive health (stool frequency, reduced constipation and well being) in both healthy and constipated individuals as well as those suffering from irritable bowel syndrome. This study aims to examine the effect of daily consumption of two green kiwifruit in healthy individuals and in individuals with functional constipation and IBS as part of their everyday lifestyle to determine if the product is effective at improving bowel regularity, digestive discomfort, digestive health and function and gut health. It will compare the efficacy of kiwifruit with psyllium (mucilage), a bowel bulking agent that has been shown to be an effective treatment for constipation. The trial will be a randomized, single blinded cross over study where participants will consume either two green kiwifruit daily for four weeks or 11g psyllium powder for four weeks. There will be a four week washout period in between and then the participants will swap over treatments for a further four weeks. The trial will start and finish with a two week washout period. Participants will be asked to complete a daily study diary (either online or by hand) to record daily bowel movement and general wellbeing during the study. Faecal and blood samples will be collected at the beginning of the trial and at the end of each treatment period. Participants will also be asked to complete a questionnaire relating to bowel health at these time 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 (2 green kiwifruit per day (Actinidia deliciosa var. Hayward), compared to a positive control intervention of psyllium (11g of psyllium per day providing 6g fibre). Compliance to the consumption of the kiwifruit will be monitored by measuring plasma vitaman C levels over the c
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 (2 green kiwifruit per day (Actinidia deliciosa var. Hayward), compared to a positive control intervention of psyllium (11g of psyllium per day providing 6g fibre). Compliance to the consumption of the kiwifruit will be monitored by measuring plasma vitaman C levels over the course of the study.
Sponsors
Zespri International
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy group: Adult (18-65 years); BMI 18-35; Generally healthy; Normal bowel habits Functionally constipated group: 1.Adult (18-65 years); Females will be required to declare stage of menstrual cycle during the different trial phases; BMI between 18-35; Presence of functional constipation according to ROME III diagnostic criteria for functional constipation. IBS-C group: 1.Adult (18-65 years); Females will be required to declare stage of menstrual cycle during the different trial phases; BMI between 18-35; Presence of functional constipation according to ROME III diagnostic criteria for IBSC.
Exclusion criteria
Individuals with alarm features associated with bowel habit (recent changes in bowel habit (<3 months), rectal bleeding, weight loss, occult blood in stools, anaemia) , anal fissures, bleeding haemorrhoids, and family history of GI cancer or IBD. Chronic disease (cardiovascular, cancer, renal failure, previous gastrointestinal surgery (not including appendectomy or cholecystectomy), neurological conditions (e.g. multiple sclerosis, spinal chord injury, stroke). All patients will be screened at recruitment for fasting blood glucose. Those with results greater than 7.2 mmol/l will not be accepted into the trial. Participants with diagnosed and stable conditions requiring the use of SSRI’s (selective serotonin reuptake inhibitors), tricyclates, opiates or anti-inflammatories will be permitted into the trial on condition the medication has been in use continually and the condition has been stable for > 3 months. Similarly those with stable and controlled diabetes (> 3 months) will be permitted to participate. Women who are pregnant, breastfeeding or planning a pregnancy in the 3 months post selection (trial period) will be excluded. Potential participants with known kiwifruit or latex allergy will be excluded. Potential participants using laxatives who are not prepared to stop using the laxatives for the 2 week lead-in period will be excluded.
Outcome results
None listed