Beneficial Effects of A Diverse Prebiotic Fibre bLend on Affect, iNflammation, Cognition, and the Gut microbiomE: a Double-blind Placebo Controlled Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Perceived Stress
研究概览
简要总结
This clinical trial will investigate whether a powdered prebiotic fibre blend, at two doses, can improve perceived stress levels in healthy adults with mild-severe stress levels.
详细描述
There is growing interest in how the gut microbiota interacts with the brain to influence psychological outcomes, particularly stress. Even in otherwise healthy individuals, persistent psychological stress is associated with measurable physiological changes-including elevated cortisol levels, heightened hypothalamic-pituitary-adrenal (HPA) axis reactivity, and systemic low-grade inflammation. These biological signatures are increasingly understood to be shaped, in part, by the composition and activity of the gut microbiota.
This study will investigate how a powdered prebiotic fibre supplement can affect stress levels. Secondary endpoints include the effects that the prebiotic fibre supplement will have on other areas of health, like depression, mood, anxiety, cognition, inflammation, and the gut microbiome.
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)
盲法说明
Study sponsor
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-50 years of age
- •Capacity to give informed consent to participate in the study
- •Able to comply with study requirements and visits
- •Meet the criteria for mild-severe stress levels (scores between 15-33) as assessed by DASS-42 Stress Subscale
- •Normal or corrected to normal vision and/or hearing
排除标准
- •Current smoker
- •Having food allergies and/or intolerances
- •Current diagnosis of Type 1 or 2 diabetes, cardiometabolic disease, or psychiatric or neurological conditions (e.g. schizophrenia, dementia) including eating disorders
- •Current or previous diagnosis of depression in past 6 months
- •Currently receiving medications that lower cholesterol, blood pressure, blood glucose levels, or improve insulin sensitivity
- •Receiving antidepressant or anti-anxiety medications or treatments
- •Receiving hormonal birth control
- •Perimenopause or menopause
- •Pregnancy, lactation, or an intent to become pregnant during the course of the study
- •Continuous antibiotic use for > 3 days within 1 month prior to enrolment
- •Continuous use of weight-loss drug for > 1 month before screening
- •Major change in dietary intake in past month (e.g. excluding whole food groups)
- •Consuming a restricted diet, including a vegan, vegetarian, and ketogenic diet
- •Currently consuming daily prebiotic or probiotic supplements
- •Any significant GI condition affecting absorption including (but not limited to) inflammatory bowel disease, weight loss surgery, irritable bowel syndrome.
- •Active cancer, or treatment for any cancer, in last 3 years
- •Consuming more than 20g of fibre a day as assessed by the FiberScreen
研究组 & 干预措施
Prebiotic fibre blend (10g)
Prebiotic fibre blend, consisting of 10g of a powdered supplement, to be taken daily alongside usual diet for 12 weeks.
干预措施: Prebiotic fibre blend (Dietary Supplement)
Prebiotic fibre blend (6g)
Prebiotic fibre blend, consisting of 6g of a powdered supplement, to be taken daily alongside usual
干预措施: Prebiotic fibre blend (Dietary Supplement)
Placebo
Placebo will be 10g of maltodextrin powder, to be taken daily alongside usual diet for 12 weeks.
干预措施: Maltodextrin (Placebo) (Dietary Supplement)
结局指标
主要结局
Perceived Stress
时间窗: Baseline and 12 weeks
The primary objective is to determine the effect of 12-week long daily administration of Prebiotic fibre blend as compared to Placebo on stress scores (Perceived Stress Scale) on a scale between 0 - 40 (where higher scores indicate higher stress).
次要结局
- Perceived Stress(Baseline and 8 weeks)
- Depression(Baseline, 8 weeks and 12 weeks)
- Mood(Baseline, 8 weeks and 12 weeks)
- Anxiety(Baseline, Week 8, and Week 12)
- Serum hs-CRP(Baseline and Week 12)
- Cognition: Auditory Verbal Learning Task (AVLT)(Baseline and Week 12)
- Cognition: Affective 2-Back Task(Baseline and Week 12)
- Cognition: Emotional Go/No-Go(Baseline and Week 12)
- Cognition: Attentional Network Task (ANT)(Baseline and Week 12)
- Cognition: Number Letter Task(Baseline and Week 12)
- Gastrointestinal symptoms(Baseline, Week 8 and Week 12)