NCT01398163已完成不适用
A f-MRI STUDY OF AFFECTIVE CHANGES ASSOCIATED WITH FOUR WEEKS CONSUMPTION OF A FERMENTED DAIRY PRODUCT IN HEALTHY WOMEN
Danone Research1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2009年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to evaluate the effect of a commercially available fermented dairy product containing probiotics (4 weeks, twice a day) on the brain activity within specific neural circuits regulating the subjective experience of emotional valence and digestive well-being.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women, right-handed, aged from 18 to 60 years
- •Subject of normal body weight or with overweight i.e. not obese (body mass index between 18 and 30 kg/m2).
- •For fertile women, complying with one of the other medically approved methods of contraception
排除标准
- •Subject with any current psychiatric or eating or suicidal attempt disorder, or history of such disorder.
- •Subject with any history of chronic GI disorder or disease.
- •Subject with any significant active or prior metabolic disorder or disease.
- •Subject with any use of probiotic supplements or antibiotics in the previous month.
- •Subject with current use of any medications with potential central nervous system effects (antidepressants, anxiolytics, opiate pain medications...).
- •Subject with allergy or hypersensitivity to milk proteins or lactose intolerance or immunodeficiency
- •Subjects with claustrophobia or other condition (such as metallic implants) that would preclude MRI scanning
研究组 & 干预措施
1 = Tested product
Experimental
干预措施: 1-Fermented Dairy Product (test) (Other)
2 = Control product
Active Comparator
干预措施: 2-Milk-based non-fermented dairy product(control) (Other)
3 = No product
No Intervention
研究者
研究点 (1)
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