title: Effects of Kivia powder on gut health in patients with occasional constipation: a randomized, double-blind, placebo-controlled study.
abstract: OBJECTIVE
  To evaluate the efficacy of Kivia powder on supporting overall gut health through the relief of the discomfort of occasional constipation.
  
  
  METHODS
  Randomized, double-blind, placebo-controlled, parallel-group trial.
  
  
  METHODS
  The 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.
  
  
  RESULTS
  One 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).
  
  
  CONCLUSIONS
  Treatment 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.
  
  
  BACKGROUND
  ISRCTN: ISRCTN49036618.
authors.affiliation: Medicus Research LLC, Agoura Hills, CA 91301, USA. jay.udani@medicusresearch.com
authors.forename: Jay K
authors.initials: JK
authors.lastname: Udani
authors.forename: David W
authors.initials: DW
authors.lastname: Bloom
mesh_terms: D015746:Abdominal Pain / Q000188:drug therapy; D029042:Actinidia / Q000737:chemistry; D000293:Adolescent; D000328:Adult; D000368:Aged; D015992:Body Mass Index; D003248:Constipation / Q000188:drug therapy*; D004311:Double-Blind Method; D004353:Drug Evaluation, Preclinical; D023381:Endpoint Determination; D005260:Female; D005638:Fruit / Q000737:chemistry; D041981:Gastrointestinal Tract / Q000187:drug effects* / Q000378:metabolism; D006801:Humans; D008297:Male; D008875:Middle Aged; D009520:New Zealand; D010936:Plant Extracts / Q000008:administration & dosage*; D011208:Powders; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D010936:Plant Extracts; D011208:Powders