Abstract
ObjectiveTo evaluate the efficacy of Kivia powder on supporting overall gut health through the relief of the discomfort of occasional constipation.DesignRandomized, double-blind, placebo-controlled, parallel-group trial.InterventionsThe investigational product for this study was Kivia powder (Vital Food Processors Ltd., Auckland, New Zealand), containing the active ingredient Zyactinase™, 5.5 g taken daily for four weeks.ResultsOne hundred thirty-eight subjects reporting occasional constipation were screened and 87 were randomized to placebo (n = 44) and product (n = 43). Bowel movement frequency, as measured by both average daily spontaneous bowel movements (SBM) and complete spontaneous bowel movements (CSBM), were the same in both groups at baseline. There were significant increases in spontaneous bowel movements at week 1 (p = 0.001), week 2 (p = 0.001), week 3 (p = 0.000), and week 4 (p = 0.000) compared to baseline. SBM demonstrated significant differences between the treatment group and the placebo group at week 3 (p = 0.000), and week 4 (p = 0.020). The treatment group demonstrated a significantly higher rate of SBM at week 3 (p = 000) and from baseline to week 4 (p = 0.019). Significant increases in complete spontaneous bowel movements were observed at week 1 (p = 0.000), week 2 (p = 0.000), week 3 (p = 0.000), and week 4 (p = 0.000) compared to baseline. Moreover, CSBM was significantly higher for the treatment group compared to placebo at week 2 (p = 0.001). The change in average daily CSBM from baseline to week 2 was significantly higher in the treatment group than in the placebo group (p = 0.004).Abdominal discomfort or pain demonstrated significant differences between groups at week 1 (p = 0.044) and week 3 (p = 0.026). Flatulence was significantly lower for active group compared to placebo at week 2 (p = 0.047) and week 3 (p = 0.023). The number of bowel movements associated with urgency was significantly lower in the treatment group compared to the placebo group at week 3 (p = 0.048). In addition, it was decreased from baseline to week 1 (p = 0.040) and from baseline to week 3 (p = 0.024) in the treatment group, while the placebo group did not report any reductions in bowel urgency. Bowel movements in the treatment arm were significantly smoother and softer by week 2 (p = 0.020) and week 3 (p = 0.041).ConclusionsTreatment with Kivia powder, an extract of kiwifruit containing Zyactinase™, for four weeks was well tolerated and more effective than placebo in gently enhancing bowel movement frequency and reducing abdominal pain and flatulence in subjects with occasional constipation.Trial registrationISRCTN: ISRCTN49036618
Highlights
According to the American Gastroenterological Association, among healthy people, the frequency of bowel movements may vary from three movements per week to three daily
The number of bowel movements associated with urgency was significantly lower in the treatment group compared to the placebo group at week 3 (p = 0.048)
The number of bowel movements associated with urgency decreased from baseline to week 1 (p = 0.040) and to week 3 (p = 0.024) in the treatment group, while the placebo group did not report any reductions in bowel urgency
Summary
According to the American Gastroenterological Association, among healthy people, the frequency of bowel movements may vary from three movements per week to three daily. Constipation may be suspected if there is difficulty or pain when passing a hardened stool or if greater than three days pass between bowel movements. Occasional constipation is common and occurs in most people at some point. In some typically healthy individuals, evacuating the bowels is difficult at times, even in the absence of any physical or physiological symptoms. Neurological, psychological, or psychosomatic problems may be the cause in some individuals. Contributing factors to constipation include gender (being female), age (being older), diet and lifestyle choices, use of certain medications, and bowel habits
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