NCT05226520已完成不适用
Effect of 6-week Probiotic Supplementation on Stress-related Parameters in Healthy Adults With Different Levels of Stress
Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2020年12月16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
- 49
- 试验地点
- 2
- 主要终点
- Salivary cortisol level
研究概览
简要总结
This is a pilot exploratory study to investigate the effects of a probiotic Bifidobacterium longum NCC3001 intake on physiological and psychophysiological parameters related to stress in healthy individuals with mild to moderate stress level.
详细描述
The purpose of the study is to explore the effects of a probiotic Bifidobacterium longum NCC3001 intake on physiological and psychophysiological parameters related to stress in healthy individuals with mild to moderate stress level.
The objectives is three:
- Measure the effects of a 6-week supplementation with NCC3001 on psychological and physiological parameters in response to an acute experimental stress;
- Measure the effects of a 6-week supplementation with NCC3001 on chronic stress level, gastro-intestinal symptoms and sleep quality;
- Explore changes in the profiles of biological parameters associated with ingestion of NCC3001; including changes in hormones, neurotransmitters, circulating immune and microbiome-derived molecules and changes in the microbiome itself
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Unique coding
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to understand and sign the informed consent
- •Healthy adult men and/or women aged 25 to 65 years old
- •Mild to moderate stress, defined as a score in the range of 15 to 25 on the validated Depression, Anxiety and Stress Scale (DASS-42)
- •Proficiency in French and/or English
- •Normal visual acuity and hearing with or without correction (self-reported)
- •BMI in the range of 18.5 to 29.9 kg/m2
排除标准
- •Diagnosed food allergies
- •Currently participating or having recently participated in a clinical study with products potentially interfering with the results as judged by the investigator
- •Organic gastrointestinal pathology other than benign polyps, diverticulosis, hemorrhoids
- •Chronic or recurrent diarrhea with spontaneous bowel movements more often than 2 times daily
- •Concurrent diagnosed systemic chronic disease (e.g., endocrine, cardiovascular, metabolic, liver, celiac)
- •Willing to avoid the consumption of probiotic-containing products (including yogurts containing probiotics) i.e. any commercially available product specified as containing Lactobacillus, Bifidobacteria, Streptococcus or Saccharomyces for the 2 weeks prior to randomization visit
- •Willing to avoid the use of antibiotics in the 4 weeks prior to randomization visit
- •Adherence to an overly unbalanced diet such as vegan, paleo, ketogenic, low carbohydrate, raw diets
- •Conditions that may affect mood
结局指标
主要结局
Salivary cortisol level
时间窗: Before the stressor (time-point -20 minutes) and after the stressor (time-point +0 min, time-point +5 min, time-point +10 min, time-point +20 min, time-point +30 min, time-point +40 min) at both baseline and after 6 weeks of treatment
Salivary cortisol levels (nmol/L) before and after stressor
次要结局
- Probiotic in feces(Baseline and after 6 weeks treatment)
- Mean heart rate variability(Baseline and after 6 weeks treatment)
- Self-reported measures before and after the stressor (PANAS)(Baseline and after 6 weeks treatment)
- Self-reported measures before, during and after the stressor (VAS)(Baseline and after 6 weeks treatment)
- Self-reported endpoints from standard questionnaires (GSRS)(Baseline and after 6 weeks treatment)
- Cortisol level from waking saliva samples(Baseline and after 6 weeks treatment)
- Heart frequency(Baseline and after 6 weeks treatment)
- Self-reported measures before and after the stressor (STAI-6)(Baseline and after 6 weeks treatment)
- Mean skin conductance level(Baseline and after 6 weeks treatment)
- Self-reported endpoints from standard questionnaires (HADs)(Baseline and after 6 weeks treatment)
- Self-reported endpoints from standard questionnaires (Pittsburgh Sleep Quality)(Baseline and after 6 weeks treatment)
- Self-reported endpoints from standard questionnaires (PSS)(Baseline and after 6 weeks treatment)
- Microbiome related metabolites in stool, blood and urine(Baseline and after 6 weeks treatment)
研究者
研究点 (2)
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