ACTRN12616000775415已完成未知
A randomised, controlled, single blinded cross-over trial to investigate the effect of Zespri SunGold kiwifruit on digestive health and gut health function in individuals with constipation with or without Irritable Bowel Syndrome.
The New Zealand Institute for Plant & Food Research0 个研究点目标入组 50 人开始时间: 2016年6月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Functionally Constipated Group and Irritable Bowel Sydrome with constipation group: Adult (18-65 years), BMI 18-25, Both male and female (females will be required to declare stage of menstrual cycle during different trial stages), Presence of Functional Constipation or Irritable Bowel Syndrome according to ROME III diagnostic criteria.
排除标准
- •1. Alarm features associated with bowel habit (recent changes in bowel habit (<3 months), rectal bleeding, weight loss, blood in stools, bleeding haemorrhoids, family history of Gastrointestinal (GI) cancer or Irritable Bowel Disease (IBD).
- •2. Chronic disease (cardiovascular, cancer, renal failure, previous GI surgery (not including appendectomy or cholecystectomy), neurological conditions (e.g. stroke, spinal chord injury, multiple sclerosis)
- •3. Fasting blood glucose of 6.0 mmol/l or greater. Participants will be screened during recruitment.
- •4. Participants with diagnosed and stable conditions requiring the use of selective serotonin uptake inhibitors, triglycerides, opiates or anti-inflammatories will only be permitted into the trial on condition that the medication has been in use continually and the condition has been stable for > 3 months. Similarly those with stable and controlled diabetes for > 3 months will also be permitted to take part in the study.
- •5. Women who are pregnant, breastfeeding or planning a pregnancy in the 3 months post selection will be excluded.
- •6. Potential participants with known kiwifruit or latex allergy will be excluded.
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