Snack Foods and Their Impact on the Gut-Brain Axis: a Randomised Controlled Trial on Mental Health and the Gut Microbiota
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Symptoms of depression and anxiety
研究概览
简要总结
The aim of this study is to investigate the effects of snack foods on mental health and the gut-brain axis, in adults with mild to moderate symptoms of depression and anxiety.
详细描述
There is increasing evidence on the potential modulating role of healthy dietary patterns in managing symptoms of psychological distress including but not limited to depression and anxiety. Despite growing evidence, further research is required to investigate how dietary interventions may impact symptoms of depression and anxiety, as well as their mechanisms of action via the gut-brain axis. Consumption of snacks now contributes to roughly 17% and 21% of daily energy intake for men and women respectively. Therefore, snacks greatly impact nutritional intake and diet quality and can be a target of dietary manipulation for potential health benefits.
This will be the first randomised controlled trial to assess the impact of snack consumption on mental health in adults with mild to moderate symptoms of depression and anxiety. The trial will use a parallel design with a 12-week intervention. Stool and blood samples will be collected at the beginning and end of the intervention for measurement of the gut microbiota and biomarkers related to the gut-brain axis.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18-45 years old.
- •Body mass index (BMI) between 18.50-29.99kg/m2
- •Score 10-29 on the patient health questionnaire anxiety and depression scale (PHQ-ADS) for mild to moderate symptoms of depression and anxiety.
- •Individuals who regularly consume snacks (Classified as ≥2 per day excluding fruit, vegetable, nut and seed snacks).
- •Willing to complete the 12-week intervention by adhering to snacks, complete mental health questionnaires, provide stool and blood samples, record weight and other anthropometric values and record food intake at various timepoints throughout the intervention.
- •Willing to adhere to the protocol and provide informed consent.
- •Fibre intake of <30g/d
- •Willing to discontinue use of pre and probiotics during the trial.
排除标准
- •Dislike of intervention products.
- •Allergy or intolerance to the intervention products
- •Self-report occurrence of substance dependency or severe mental health conditions (e.g., psychosis, schizophrenia, eating disorder). Those with depressive disorders or anxiety disorders will be included in the trial providing they meet all other inclusion criteria.
- •Regular consumption of experimental product as snacks and unwilling to complete a washout (no consumption for 4 weeks before baseline or during the study period).
- •Changes to medication for depression or anxiety within the last 3 months (e.g., dosage, frequency, type)
- •Initiation of any new medications for mental health or any form of talk therapy within the last 3 months.
- •Intention to start or alter medication or therapy for mental health during the study.
- •Current or previous antibiotic treatment within 4 weeks prior to the start of the study.
- •Consumption of probiotics or prebiotic products within the 2 weeks prior to the start of the study
- •Women who are pregnant, lactating or planning pregnancy
- •Unexplained or unintentional weight loss in the past six months
- •Medical history of any of the following: diabetes, major active or historic psychiatric conditions (e.g. schizophrenia), current eating disorder, alcohol abuse, active treatment for cancer in the last year, severe neurological, endocrine, renal, cardiac or pulmonary disease (or any other chronic medical condition), severe oesophagitis, gastritis or duodenitis, active diverticulitis or intestinal/colonic strictures, Coeliac disease, Crohn's disease or Ulcerative colitis, stem cell or organ transplant, gut resection surgery (excluding appendicectomy and cholecystectomy), bleeding disorder, anaphylaxis or any other major or chronic condition known to impact study outcome measures.
结局指标
主要结局
Symptoms of depression and anxiety
时间窗: Week 0 and 12
Symptoms of depression and anxiety as measured by the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). This is a 15-item self-report likert scale comprising the PHQ-8 and GAD-7. Scores can range from 0 to 48, cut points of 10,20 and 30 indicate mild, moderate and severe levels of depression/anxiety respectively.
次要结局
- Dietary intake(Week 0 and 12)
- Wellbeing(Weeks 0,6 and 12)
- Faecal water(Week 0 and 12)
- Stool frequency(Week 0 and 12)
- Stool consistency(Week 0 and 12)
- Serum Vitamin E levels(Week 0 and 12)
- Acceptability of snack products(Week 12)
- Adverse events(Week 0 to 12)
- Snack compliance(Week 12)
- Symptoms of depression(Weeks 0,6 and 12)
- Symptoms of anxiety(Weeks 0,6 and 12)
- Psychological Distress(Weeks 0,6 and 12)
- Faecal gut microbiota (composition, alpha- and beta-diversity)(Week 0 and 12)
- Faecal short-chain fatty acids (SCFA)(Week 0 and 12)
- Physical activity(Weeks 0,6 and 12)
- Functional impairment(Weeks 0,6 and 12)
- Sleep quality(Weeks 0,6 and 12)
- Proportion of people with no, mild, moderate and severe symptoms of depression(Week 0, 6 and 12)
- Gut symptoms(Week 0 and 12)
- Symptoms of depression and anxiety(Week 0,6 and 12)
- Change in symptoms of depression and anxiety(Week 0, 6 and 12)
- Proportion of people with no, mild, moderate and severe symptoms of anxiety and depression(Week 0, 6 and 12)
- Quality of life(Weeks 0,6 and 12)
- Proportion of people with no, mild, moderate and severe symptoms of anxiety(Week 0, 6 and 12)