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Effects of Kivia powder on gut health in patients with occasional constipation
ISRCTN ISRCTN49036618
DOI 10.1186/ISRCTN49036618
ClinicalTrials.gov identifier
EudraCT number
Public title Effects of Kivia powder on gut health in patients with occasional constipation
Scientific title Effects of Kivia powder on gut health in patients with occasional constipation: A randomized double-blind, placebo-controlled study
Acronym N/A
Serial number at source VTLF1400
Study hypothesis The aim of the study is to evaluate the ability and safety of a proprietary extract of kiwifruit containing zyactinase in individuals with occasional constipation by observing change in bowel movement frequency.
Lay summary Lay summary under review 1
Ethics approval Institutional Review Board (IRB) (Copernicus Group IRB, Cary, NC); August 2010
Study design Randomized double-blind placebo-controlled study
Countries of recruitment United States of America
Disease/condition/study domain Constipation
Participants - inclusion criteria 1. Healthy adults, between 18 and 65 years of age and with a body mass index (BMI) between 20 and 35kg/m2
2. The subjects had symptoms consistent with occasional constipation, these included at least two of the following occurring during the two-week run-in period:
2.1. Three or fewer defecations per week
2.2. Straining during at least 25% of defecations
2.3. Lumpy or hard stools in at least 25% of defecations
2.4. A sensation of incomplete evacuation for at least 25% of defecations
2.5. A sensation of anorectal obstruction or blockage for at least 25% of defecations, and
2.6. Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor)
3. Subjects were also required to be willing to maintain his or her habitual food and beverage intake (other than substitution of study food for similar products) and physical activity patterns throughout the study period. The subjects were judged by the investigator to be in general good health on the basis of their medical histories
4. Informed consents were signed
Participants - exclusion criteria 1. Any significant gastrointestinal condition that would potentially interfere with the evaluation of the study product, including, but not limited to, inflammatory bowel disease (ulcerative colitis or Crohnís)
2. A history of frequent diarrhea
3. A history of surgery for weight loss (including gastric bypass or lapband)
4. A history of perforation of the stomach or intestines
5. Gastroparesis, or clinically important lactose intolerance
6. Clinically significant renal, hepatic, endocrine (including diabetes mellitus), cardiac, pulmonary, pancreatic, neurologic, hematologic, or biliary disorders
7. Known allergy or sensitivity to kiwifruit
8. A recent (within two weeks of visit 1, week -1) episode of acute gastrointestinal illness such as nausea, vomiting, or diarrhea
9. A history or presence of cancer in the prior two years, except for nonmelanoma skin cancer
10. A recent history of (within 12 months) or a strong potential for alcohol or substance abuse
11. Participation in a clinical study with exposure to any nonregistered drug product within 30 days prior to the study 12. Any condition believed to interfere with ability to provide informed consent or comply with the study protocol, or believed to confound the interpretation of the study results or put the person at undue risk
13. Any active infection or any infection in the previous month requiring antibiotics, antiviral medication, or hospitalization
14. Diabetes requiring medication
15. Untreated or unstable hypothyroidism
16. Weight loss or gain of ≥ 20 pounds in the previous three months
17. A clinically significant abnormal physical examination
18. An active eating disorder, including anorexia nervosa, bulimia, and/or obsessive compulsive eating disorders
19. Central neurological disorders, including, but not limited to, spinal cord injuries, multiple sclerosis, and Parkinsonís disease
20. An unwillingness to discontinue all laxatives or all dietary supplements and
21. Pregnancy, lactation, or an unwillingness to use adequate contraception for the duration of the study
Anticipated start date 01/08/2010
Anticipated end date 31/10/2011
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 87
Interventions Subjects received one of the following two interventions

identical placebo or one sachet of Kivia powder, containing the active ingredient zyactinase (5,500mg), daily for four weeks.

Eighty-seven men and women were randomized to the study (43 to Kivia powder and 44 to placebo), and 82 completed the study (n=39 in the treatment group). These 82 subjects were included in the analysis. Five subjects did not complete the study because they were lost to follow-up.
Primary outcome measure(s) Efficacy of Kivia powder compared to placebo on bowel movement frequency (the number of bowel movements per week)
Secondary outcome measure(s) Efficacy of Kivia powder compared to placebo:
1. On gut health, including stool form (Bristol Stool Scale)
2. Bowel urgency
3. Abdominal bloating
4. Abdominal discomfort or pain
5. Satisfaction with bowel habits, flatulence, and burping
6. The use of rescue medication and safety, based on adverse events

Measured in daily diaries which were collected on each visit such that V1 (Screen/ Run-in), V2(Randomization) = Day 0, V3= Week 2, V4 (End of Study) = Week 4
Sources of funding Medicus Research, LLC (USA)
Trial website
Publications 1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23758673
Contact name Dr  Jay  Udani
  Address 18250 Roscoe Blvd, Suite 220
  City/town Northridge
  Zip/Postcode 91325
  Country United States of America
Sponsor Vital Food Processors Ltd (New Zealand)
  Address 78 Ascot Rd
PO Box 107-071
  City/town Auckland
  Zip/Postcode 2022
  Country New Zealand
Date applied 26/01/2012
Last edited 01/07/2013
Date ISRCTN assigned 23/02/2012
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