Accepted for/Published in: JMIR Research Protocols
Date Submitted: Mar 31, 2025
Date Accepted: Nov 20, 2025
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Normalization of gastrointestinal symptoms in adults with constipation with daily green kiwifruit consumption: protocol for an open-label intervention study.
ABSTRACT
Background:
Constipation-predominant irritable bowel syndrome (IBS-C) and functional constipation (FC) have significant personal, healthcare, and social impacts, affecting patients’ quality of life. Treatment for these conditions is challenging. While green kiwifruit is a promising natural alternative to laxatives, its effectiveness in managing abdominal pain and the underlying mechanism of action is yet to be substantiated.
Objective:
This study investigates the effect of consuming two green kiwifruit daily for four weeks (the habitual serving) on abdominal pain and discomfort in individuals with IBS-C and FC.
Methods:
This study is a two-arm parallel, open-label, placebo-controlled randomized study. The study duration was nine weeks, with a three-week lead-in phase, a four-week intervention phase, and a two-week follow-up phase. Sixty participants with IBS-C and FC were randomized to consume either two Zespri® green kiwifruit (Actinidia deliciosa ‘Hayward,’ ~150 g per serving, ~90 kcal) or maltodextrin (calorie-matched to the fruit, ~ 25 g per serving, ~90 kcal) per day for four weeks. The participants completed validated questionnaires assessing digestive and general health and well-being parameters, underwent magnetic resonance imaging to determine colon physiological measures, ingested a blue food dye, provided blood and fecal samples to measure microbial, immunological, and biochemical parameters, and ingested wireless motility devices (selected participants only) to assess physiological processes.
Results:
Recruitment for this study began in May 2021 and was completed in May 2022. Sixty-three participants were randomized, and 57 were analyzed using intention-to-treat analysis. Data analysis is complete, and full results are expected to be published in peer-reviewed journals by the end of 2025.
Conclusions:
This study aims to evaluate the effectiveness of green kiwifruit consumption in managing abdominal pain in individuals with IBS-C and FC. It will provide new insights into the mechanisms behind the habitual consumption of green kiwifruit on digestive comfort in this population. Clinical Trial: Australian New Zealand Clinical Trial Registry (ACTRN) 12621000621819
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