NCT01931930已完成不适用
Effect of Perilla Extract on Improvement of Intestinal Discomfort and Bowel Function in Healthy Volunteers With Gastrointestinal Discomfort
Amino Up Chemicals Co., Ltd.2 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2012年7月1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
- 47
- 试验地点
- 2
- 主要终点
- daily gastrointestinal symptoms
研究概览
简要总结
In the current study the effects of proprietary Perilla frutescens leaf extract in comparison to Maltodextrin, a fully digestible carbohydrate (placebo control), on gastrointestinal discomfort and bowel function were investigated. The study was performed double-blind and placebo-controlled with a 4 week intervention period. Study products were taken two times daily (each one capsule before breakfast and dinner).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers without clinical diagnosed diseases with relevant effect on the gastrointestinal system or on visceral motility.
- •BMI: 19-30 kg/m2
- •Reduced bowel movements defined as an average of >1 and ≤ 3.5 stools per week for at least the previous 6 months
- •Gastrointestinal symptoms of at least 5 points
- •Male or female
- •Age ≥ 30 and ≤ 70 years
- •Nonsmoker
- •Written consent to participate in the study
- •Able and willing to follow the study protocol procedures
排除标准
- •Subject under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs or other digestive auxiliaries
- •Relevant history, presence of any medical disorder or intake of medication / dietary supplements, potentially interfering with this trial at screening
- •Subjects with stool frequency of ≤ 1 stool every 7 days or > 3,5 stools per week
- •Subjects not willing to avoid pre- and probiotics for the duration of the study
- •Intake of antibiotics in the last 4 weeks and laxatives in the last 2 weeks
- •Change of dietary habits within the 4 weeks prior to screening (for instance start of a diet high in fibers)
- •Pregnant subject or subject planning to become pregnant during the study; breast-feeding subject.
- •Subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to co-operate during the study.
- •Participants anticipating a change in their lifestyle or physical activity levels since this may also influence the results.
- •Known food intolerance or allergy.
- •Subject involved in any clinical or food study within the preceding month
结局指标
主要结局
daily gastrointestinal symptoms
时间窗: was assessed daily during 4 week intervention
The following gastrointestinal were rated and reported by the study participants on a daily based. Bloating, rumbling, feeling of fullness, passage of gas, abdominal discomfort (pain and cramps). The rating was done based on a number scale. 0 not at all and 4 extremely.
次要结局
- validated questionnaires(assessed at visit 1 (before) and at visit 2 (after 4 week intervention))
- stool consistency(reported at days with stool during 4 week intervention)
- Adverse events(assessed at visit 1 (before) and at visit 2 (after 4 week intervention))
- Stool frequency(reported at days with stool during 4 week intervention)
研究者
研究点 (2)
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