ISRCTN49036618已完成不适用
Effects of Kivia powder on gut health in patients with occasional constipation: a randomized double-blind, placebo-controlled study
Vital Food Processors Ltd (New Zealand)0 个研究点目标入组 87 人开始时间: 2012年2月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 87
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Healthy adults between 18 and 65 years of age and with a body mass index (BMI) between 20 and 35 kg/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
- •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
排除标准
- •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 Crohn?s)
- •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 Parkinson?s disease
- •20. An unwillingness to discontinue all laxatives or all dietary supplements
- •21. Pregnancy, lactation, or an unwillingness to use adequate contraception for the duration of the study
研究者
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