Bridging the Fibre Gap: A Pre-post Single-arm Feasibility Trial on Increased Fibre Intake and Mental Wellbeing
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Generalized Anxiety Disorder 7 scale scores
研究概览
简要总结
This feasibility study will explore whether adding an extra 10 grams of fibre to participants' daily diet for two weeks would improve their mental health and wellbeing.
详细描述
The current pre-post single-arm feasibility trial will investigate whether increasing daily fibre intake by 10 grams for two weeks enhance depression, anxiety, stress, sleep quality, gut health, and optimism in 18-40 year-old young adults. Participants will be provided a list of high fibre food items. Outcome measures will be acquired before and after 2-weeks . These will include cognitive measures of measures of depression, anxiety, and stress symptomatology; sleep; gastrointestinal symptomatology; optimism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aging between 18-40 years old
- •Having normal vision and hearing
- •Having a body mass index between 18.5 and 30
- •Not following a high fibre diet >20g fibre/day as assessed by using the FiberScreen
排除标准
- •Having food allergies
- •Following restrictive and/or unbalanced diets
- •Changing dietary intake majorly in past month
- •Being diagnosed with any psychiatric or neurologic conditions
- •Being diagnosed with any cardiometabolic diseases, or hypertension or thrombosis related disorders or suffer from thyroid disease
- •Currently taking anticoagulants, antiplatelet medication, antidepressants, proton-pump inhibitors
- •Currently consuming prebiotic or probiotic supplements or laxatives
- •Continuous antibiotic use for > 3 days within 1 month prior to enrolment
- •Continuous use of weight-loss drug for > 1 month before screening
- •Having a significant gastrointestinal (GI) condition
研究组 & 干预措施
Fibre arm
干预措施: Fibre arm (Other)
结局指标
主要结局
Generalized Anxiety Disorder 7 scale scores
时间窗: From baseline (pre intervention) to week 2 (post intervention)
A validated self-report measure of anxiety
Patient Health Questionaire-8 scores
时间窗: From baseline (pre intervention) to week 2 (post intervention)
A validated self-report measure of depression
Perceived Stress Scale scores
时间窗: From baseline (pre intervention) to week 2 (post intervention)
A validated self-report measure of stress
次要结局
- Pittsburgh Sleep Quality Index scores(From baseline (pre intervention) to week 2 (post intervention))
- Gastrointestinal Symptom Rating Scale Scores(From baseline (pre intervention) to week 2 (post intervention))
- Revised Life Orientation Test Scores(From baseline (pre intervention) to week 2 (post intervention))
研究者
Piril Hepsomali
Principle Investigator
University of Reading