NCT04796259已完成不适用
Malt-derived Ingredients and Their Prolactinotrophic Effects
Société des Produits Nestlé (SPN)1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2021年2月5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
- 12
- 试验地点
- 1
- 主要终点
- Prolactinotrophic effect
研究概览
简要总结
This proof-of-concept study aims to investigate whether malt-derived ingredients have acute prolactinotrophic effects in healthy women of child-bearing age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subjects who have/are
- •Willing and able to provide written informed consent
- •Healthy women aged 18 to
- •BMI in the range of 18 to
- •Willing to undergo an experiment in the follicular phase of the menstrual cycle i.e. day 0 to 14 of the menstrual cycle starting from the first day of the period.
排除标准
- •Subjects who have/are
- •Allergic to tested products
- •Under regular medication including oral contraceptive pills or other form of hormonal replacement therapy.
- •Under medications which affects prolactin levels.
- •Pregnant or lactating or planning to conceive during the study period.
- •Smokers, or excessive alcohol consumption (alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer) or other substance abuse.
- •Not willing and/or not able to comply with the study procedures and requirements.
- •Suffering from pre-existing medical conditions and chronic illnesses that in the opinion of the investigator may interfere with the study.
- •Family or hierarchical relationships with research team members
研究组 & 干预措施
Intervention 2
Experimental
Malt ingredient II
干预措施: Malt ingredient (Dietary Supplement)
Negative control
No Intervention
Water
Positive control
Active Comparator
Non-alcoholic beer solids
干预措施: Non-alcoholic beer solids (Dietary Supplement)
Intervention 1
Experimental
Malt ingredient I
干预措施: Malt ingredient (Dietary Supplement)
结局指标
主要结局
Prolactinotrophic effect
时间窗: 2 hours post consumption
Δ of serum Prolactin Cmax between test products, positive control of beer solids and negative control of still water
次要结局
- Gastrointestinal tolerability(2 hours post consumption)
研究者
研究点 (1)
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