Irritable Bowel Syndrome Clinical Trial
Official title:
The Effect of Zespri Green Kiwifruit on Digestive and Gut Health Functions: a Multi-country, Randomized, Cross-over Clinical Intervention
The proposed study will primarily demonstrate the efficacy of kiwifruit as a food intervention for the relief of constipation and associated symptoms in functionally constipated adults, and those with IBS-C. Secondary measures will show the consumption of kiwifruit will result in improvements in gastro-intestinal discomfort levels of adults with IBS-C.
The study is a randomised, single-blinded, cross-over design. Both target study populations
(those with functional constipation, and the matched healthy control group) will complete the
16-week trial. Each study group will be randomly selected to either begin the first
intervention period on the kiwifruit treatment or the psyllium treatment, and following the
washout period will then receive the opposite treatment. Researchers and analysts will be
blind as to as to the order of treatment individuals will receive. A dedicated treatment
administrator will be assigned to provide the treatments to participants and liaise with them
during the intervention phases.
All participants will be free living and required to maintain their normal dietary and
lifestyle habits for the duration of the trial.
The primary outcome measure will be quantification of CSBM (complete spontaneous bowel
movement). Secondary outcome measures will include additional stool frequency measures and
other questionnaires.
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