Green and gold kiwifruit powders consumed for 28 days by healthy individuals with occasional constipation are safe and well-tolerated: A randomized controlled trial

Abstract

Constipation is a global issue which impacts quality of life. Therapeutic laxatives are used to rescue constipation, but they may have side effects such as urgency, gas, bloating or gastrointestinal discomfort. Kiwifruit are thought to promote laxation without the urgency induced by therapeutic laxatives. The objective of this study was to examine the safety and tolerability of a 2,400 mg daily dosage of green kiwifruit powder or gold kiwifruit powder, a 600 mg of green kiwifruit powder or gold kiwifruit powder combined with cellulose, and a combination of 600 mg green kiwifruit powder plus 1,400 mg xylo-oligosaccharide. This randomised, double-blinded, placebo-controlled, parallel study for 28 days across four North American sites (NCT03462199) enrolled 288 participants with non-pathological constipation who had ≤3 complete spontaneous bowel movements (CSBM) per week. Baseline demographics, anthropomorphic and vital signs, clinical chemistry and hematology, and patient assessment of quality-of-life questionnaire, and adverse events data were collected at baseline and end of intervention. All investigational products had no clinically relevant changes to blood chemistry or hematology, and no adverse events linked to the investigational products. However, there were significant (p < 0.05) within-group improvements in patient-assessed quality of life scores in physical discomfort, psychosocial discomfort, worries/concerns, and satisfaction, and overall PAC-QoL scores for all products and placebo. These kiwifruit-derived products were safe and well-tolerated.