The Effect of Galacto-oligosaccharides (GOS) on Self-perceived Stress in Apparently Healthy But Stressed Dutch Women: Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Perceived stress
研究概览
简要总结
In modern life, many people state to experience stress. Women compared to men report more and higher levels of stress. Recent research found that supplementation of galactose-oligosaccharides (GOS) resulted in reduced anxiety levels in British female students with higher anxiety scores at baseline in self-reported trait anxiety. Moreover, supplementation of probiotics in germ-free rodents resulted in reduced levels of circulating corticosterone (cortisol in humans). These findings illustrate the potential of prebiotic supplementation, through the microbiota-gut-brain (MGB) axis, to improve mental health and wellbeing.
The present study aims to study the effect of oligosaccharides on self-perceived stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy women
- •Moderate or high stress level; DASS42 stress sub-score ≥19
- •Age between 25 and 45 years
- •Body mass index (BMI) between 18.5 and 30 kg/m2
- •Access to internet and a smart phone
排除标准
- •Any metabolic, gastrointestinal, inflammatory or chronic disease
- •History of gastro-intestinal surgery or having (serious) gastrointestinal discomfort
- •Use of supplement to relief stress during or within 2 weeks prior to the start of the study
- •Use of pre- and/or probiotics during the study (except for the study product) or within 4 weeks prior to the start of the study
- •Use of medication that may influence the study results, such as laxatives
- •Self-reported and/or clinical lactose intolerance
- •Self-reported and/or active cow's milk protein allergy
- •Pregnant or lactating (or having the wish to become pregnant during the study period, self-reported)
- •Having used antibiotics in the 6 months prior to the start of the study
研究组 & 干预措施
Relax+
Relax+ consists of a powder containing a blend of two prebiotics.
干预措施: Relax+ (Dietary Supplement)
Placebo
The placebo contains maltodextrin.
干预措施: Maltodextrin (Dietary Supplement)
结局指标
主要结局
Perceived stress
时间窗: 28 days
The difference in absolute stress sub-score after the product intervention between the product groups (using the Depression Anxiety Stress Scale (DASS-42)), in which a lower score corresponds with a lower stress level
次要结局
未报告次要终点