Effects of Short Chain Fatty Acids on Affective Processes in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Stress sensitivity
研究概览
简要总结
The role of short chain fatty acids (SCFA) in the microbiota-gut-brain axis is examined in a sample of healthy volunteers. SCFA are the major products of bacterial fermentation of dietary fiber in the colon, and are hypothesised to mediate the bidrectional communication between the gut and the residing microbiota on the one hand, and the central nervous system on the other hand. We perform a 1-week intervention with SCFA and measure their effects on a range of affective outcomes in healthy male volunteers.
详细描述
The study is an interventional double-blind, placebo-controlled, parallel group design with 3 arms (placebo, high-dose of SCFA, and low-dose of SCFA). The high and low doses of SCFA are equivalent to 20 and 10 grams of fiber respectively. Healthy male participants follow a low-fiber diet for the study duration (11 days). On day 4, baseline measurements are taken in the lab, including biological samples and psychophysiological measurements. Participants then consume placebo or SCFA for one week and revisit the lab on day 11 for a second measurement of the outcomes of interest. Specifically, we investigate the effect of SCFA supplementation on affective processing, including stress sensitivity, fear-related processes (e.g. extinction learning), and attentional bias to emotional stimuli. Volunteers also respond to questionnaires in relation to mood, and provide biological samples (blood and faecal samples) for analysis of circulating short chain fatty acids and microbiota composition, 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
- Single (Participant)
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 18.5-27
- •Dutch 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 are capsules containing cellulose.
干预措施: SCFA mixture (Dietary Supplement)
SCFA mixture low dose
Encapsulated SCFA mixture in the ratio of 67:6:27 (acetate, propionate, butyrate) equivalent of 10 grams of fiber.
干预措施: SCFA mixture (Dietary Supplement)
SCFA mixture high dose
Encapsulated SCFA mixture in the ratio of 67:6:27 (acetate, propionate, butyrate) equivalent of 20 grams of fiber.
干预措施: SCFA mixture (Dietary Supplement)
结局指标
主要结局
Stress sensitivity
时间窗: 1 year
Induction of cognitive, physical, and social stress using Maastricht Acute Stress Test. Stress hormone cortisol is quantified.
次要结局
- Stress sensitivity (subjective)(1 year)
- Fear(1 year)
- Microbiota composition(1 year)
- Fear (subjective)(1 year)
- Cortisol awakening response(1 year)
- Attentional bias to emotional stimuli(1 year)
- Positive and Negative Affect Schedule (PANAS)(1 year)
- Perceived Stress Scale (PSS)(1 year)
- Depression, Anxiety, and Stress Scale (DASS-21)(1 year)
- Gastointestinal symptom rating scale (GSRS)(1 year)
- Circulating SCFA(1 year)
研究者
Kristin Verbeke
Prof. Dr. Kristin Verbeke
KU Leuven