The Effects of Chicory Root-derived Prebiotic on Mood and Stress Responsiveness in Healthy Adults With Mild to Moderate Levels of Stress and Anxiety: a Randomized, Placebo-controlled, Double-blind, Monocentric, Two-armed Parallel, Prospective Study - The PRIME Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Anxiety (STAI-X1, state)
研究概览
简要总结
Emerging evidence from preclinical research suggests that prebiotic fibres may play a beneficial role in supporting mental health through modulation of the gut-brain axis-a complex communication network linking the gastrointestinal tract and the central nervous system. Chicory root-derived prebiotic fibre, already well-established for its positive effects on glycaemic control and bowel regularity, has recently shown promise in this context. The present study aims to investigate the mental health benefits of chicory root fibre in a larger and more diverse population, thereby contributing to the growing body of evidence supporting nutritional strategies for mental well-being.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
To reduce potential bias, the study will blind all key parties involved: participants, investigators, and those evaluating the outcomes.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteer is healthy at the time of screening.
- •TICS Screening Scale of Chronic Stress (SSCS) score ≥
- •GAD total score ≥ 5 and ≤ 14 indicating mild to moderate anxiety.
- •Male or female aged ≥18 and ≤ 70 years at the time of screening.
- •Body-Mass-Index (BMI) ≥ 18.5 and ≤ 29.9 kg/m
- •Volunteer is able and willing to comply with the study instructions.
- •Volunteer is suitable for participation in the study according to the investigator/study personnel.
- •Voluntary, written informed consent to participate in the study.
排除标准
- •No command of local language.
- •Previously or currently diagnosed neurological or psychiatric disorders.
- •Previous history of renal, hepatic, cardiovascular disease or clinically significant diabetes.
- •Gastrointestinal disorders including irritable bowel syndrome (IBS), inflammatory bowel disease (IBD) or other conditions that might affect the gut environment.
- •Contraindication or allergy to any substance in the verum or placebo product incl. lactose or fructose intolerance.
- •Use of drugs (e.g., antibiotics, aspirin, proton pump inhibitors) influencing gastrointestinal function in the previous 8 weeks before the beginning of intervention.
- •Use of laxatives and labelled pre-and probiotics in the previous 4 weeks before the beginning of intervention.
- •Participation in another study with any investigational product within 30 days of screening or during the study.
- •History of drug (recreational) or alcohol abuse.
- •Use of anti-depressants medication including selective serotonin receptor inhibitors or amitriptyline for 3 months prior to screening.
- •Bowel preparation for investigative procedures in the 4 weeks prior to screening.
- •Surgical resection of any part of the bowel.
- •Pregnant or lactating.
- •Regular smoking.
- •Previous Trier Social Stress Test (TSST) participation.
研究组 & 干预措施
Prebiotic fiber
The prebiotic fiber group will receive prebiotic fiber during the 4-week intervention period.
干预措施: Prebiotic fiber (Dietary Supplement)
Placebo control
The placebo group will receive maltodextrin during the 4-week intervention period.
干预措施: Placebo control (Dietary Supplement)
结局指标
主要结局
Anxiety (STAI-X1, state)
时间窗: Baseline and after 4 weeks (before and during stress protocol TSST).
Anxiety as a temporary emotional state will be assessed with State-Trait-Anxiety Inventory (STAI-X1, state). Total scores range from 20-80, with higher scores indicate greater levels of current anxiety.
Anxiety (VAS)
时间窗: Baseline and after 4 weeks (before and during stress protocol TSST).
Anxiety as a temporary emotional state will be assessed with 100-mm visual analogue scale (VAS). Higher scores shown in VAS indicating higher levels of anxiety.
次要结局
- Beck's Anxiety Inventory (BAI)(Four weeks.)
- Beck's Depression Inventory (BDI)(Four weeks.)
- Depression Anxiety Stress Scale (DASS)(Four weeks.)
- Positive and Negative Affect Schedule (PANAS)(Four weeks.)
- Dietary intake(Four weeks.)
- Beck's Anxiety Inventory (BAI)(Four weeks.)
- Beck's Depression Inventory (BDI)(Four weeks.)
- Depression Anxiety Stress Scale (DASS)(Four weeks.)
- Positive and Negative Affect Schedule (PANAS)(Four weeks.)
- Salivary cortisol(Baseline and after 4 weeks (before and during stress protocol TSST).)
- Blood pressure(Baseline and after 4 weeks (before and during stress protocol TSST).)
- Gut microbiota(Four weeks.)
- Dietary intake(Four weeks.)
- Pulse/heart rate(Baseline and after 4 weeks (before and during stress protocol TSST).)