Effects of Butyrate on Affective Processes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Stress sensitivity (cortisol)
研究概览
简要总结
The effects of butyrate on psychobiological processes are examined in a sample of healthy volunteers.
详细描述
The study is an interventional triple-blind, placebo-controlled, parallel group design with 2 arms (placebo, butyrate). Healthy male participants adhere to a low-fiber diet for the duration of the study (11 days). At the baseline study visit, measurements are taken in the lab, including biological samples and psychophysiological measurements. Participants then consume placebo or butyrate for 1 week and revisit the lab on day 11 for a second measurement of the outcomes of interest. Specifically, we investigate the effect of colonic butyrate administration on affective processing, including stress sensitivity and fear-related processes (e.g. extinction learning). Volunteers also respond to questionnaires in relation to mood and GI symptoms, and provide biological samples (saliva, blood, and faecal samples) for analysis of cortisol levels, circulating short chain fatty acids and serum BDNF, and faecal SCFA, respectively.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants, investigators, and personnel involved in data analyses are blinded to the intervention. Unblinding occurs after all data has been collected AND analysed.
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male participants
- •Age range 20-40 years
- •BMI range 18.5-25
- •Dutch or English as native-language
排除标准
- •previous or current neurological, psychiatric, gastrointestinal or endocrine disorders, or other relevant medical history
- •current or recent regular medication use
- •previous or current substance/alcohol dependence or abuse (> 2 units per day/14 units per week)
- •one or more diagnoses based on the mini-international neuropsychiatric interview
- •night-shift work
- •adherence to vegan or vegetarian diets
- •use of pre- or probiotics within one month preceding the study
- •use of antibiotics within 3 months preceding the study
- •previous experience with one of the tasks used in the study
研究组 & 干预措施
Placebo
Placebo (cellulose)
干预措施: Placebo (Dietary Supplement)
Butyrate
Sodium butyrate
干预措施: Butyrate (Dietary Supplement)
结局指标
主要结局
Stress sensitivity (cortisol)
时间窗: through study completion, on average 1 year and 5 months
Induction of cognitive, physical, and social stress using Maastricht Acute Stress Test. Stress hormone cortisol is quantified by gathering multiple saliva samples throughout the stress induction and recovery during both pre-intervention and post-intervention visit.
次要结局
- Faecal SCFA(through study completion, on average 1 year and 5 months)
- Serum SCFA(through study completion, on average 1 year and 5 months)
- Fear (subjective)(through study completion, on average 1 year and 5 months)
- Stress sensitivity (subjective)(through study completion, on average 1 year and 5 months)
- Leiden Index of Depression Sensitivity-Revised (LEIDS-R)(through study completion, on average 1 year and 5 months)
- Gastrointestinal symptom rating scale (GSRS)(through study completion, on average 1 year and 5 months)
- Cortisol awakening response(through study completion, on average 1 year and 5 months)
- Fear(through study completion, on average 1 year and 5 months)
- Positive and Negative Affect Schedule (PANAS)(through study completion, on average 1 year and 5 months)
- Perceived Stress Scale (PSS)(through study completion, on average 1 year and 5 months)
- Depression, anxiety, and stress scales (DASS-21)(through study completion, on average 1 year and 5 months)
- Serum BDNF(through study completion, on average 1 year and 5 months)
研究者
Kristin Verbeke
Prof. Dr. Kristin Verbeke
KU Leuven