PROMOTE: The Effect of Prebiotic Supplementation on Salivary Cortisol Awakening Response in Young Adults With Mild-To-Moderate Self-Reported Stress: A Double Blinded Parallel Randomised Controlled-Trial.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Salivary Cortisol Awakening Response - Biological salivary cortisol (µg/dL)
研究概览
简要总结
The study will investigate whether taking a prebiotic for six weeks helps to reduce morning cortisol levels in healthy young adults with mild to moderate stress compared to a placebo. Individuals should continue with their usual lifestyle during the study. Other factors of wellbeing will also be assessed.
详细描述
PROMOTE is a double blinded parallel randomised controlled-trial investigating if prebiotic supplementation reduce awakening salivary cortisol response, reported as area under the curve compared to a maltodextrin placebo in healthy young adults with a mild-to-moderate self reported stress score. There will be a focus on biological secondary outcomes to better understand how supplementation may influence the microbiome using metabolomics and sequencing techniques. In addition to other measures of wellbeing captured by questionnaires and activity monitors.
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
Research nurses, Independent investigators
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18-25 at time of recruitment
- •Body Mass Index (18.5 - 29.9 kg) : Healthy - Overweight
- •Stress score of 15≤ - ≥25 (DASS)
- •Willing and with capacity to give informed consent to participate at time of recruitment
- •Speak and comprehend English to a good standard
- •In good general health
- •Willing to provide stool, urine and blood (8mL) sample during intervention
- •Willing to attend 4 visits to Southampton General Hospital Clinical Research Facility over 10-11 weeks
排除标准
- •Consuming ≥ 14 units of alcohol/week (6 x 175 mL of wine, 6 pints of 4% beer)
- •Learning or behavioural difficulties (assessed on individual basis)
- •Planning a pregnancy in the next 6 months, pregnant, lactating or had a recent birth ≥6 months
- •Currently smoking or using e-cigarette, vape
- •Vulnerable adults (with self reported sever or very severe stress score (DASS)
- •Unwilling to suspend existing probiotic / prebiotic supplementation (with additional 4 weeks washout) before starting study.
- •Medical exclusions:
- •Actively involved in therapy or psychiatric intervention of a diagnosed mental health condition
- •Prescribed psychotropic medication (Antidepressants, Monoamine Oxidase Inhibitors (MAOI's), Antipsychotics, sleeping pills, mood stabilisers etc)
- •Allergic to milk, soy, corn, penicillin or fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPS)
- •Currently prescribed laxatives, enemas, anti-coagulants or painkillers
- •Existing medical condition: cancer, hepatobiliary surgery, diabetes or diagnosed gastrointestinal diseases (irritable bowel disease, ulcerative colitis)
- •Involved in a recent pharmacology/psychological intervention, last 6 months
- •Recent antibiotic prescription, last 6 months
研究组 & 干预措施
Maltodextrin
Maltodextrin (Corn origin)
干预措施: Maltodextrin (Corn) (Dietary Supplement)
Prebiotic
WellBiome® prebiotic complex Inulin 67%, Xylooligosaccharides (XOS) 27%, Magnesium Chloride (MgCl2) 9.8 %
干预措施: Prebiotic (Dietary Supplement)
结局指标
主要结局
Salivary Cortisol Awakening Response - Biological salivary cortisol (µg/dL)
时间窗: 6 collections across two working mornings per timepoint. (2 'baseline' - week 0 before supplementation; 2 'endpoint' - week 6 of supplementation ; 2 'follow-up' - within 3rd week (week 9) of supplement end)
Salivary Cortisol Awakening Response (µg/dL) Measured on awakening and hereafter at 0, 15 , 30, 45 minutes Quantified by ELISA and presented as area under the curve, for each timepoint. Example outcome: 'Awakening salivary cortisol response was significantly lower in the prebiotic group compared to the placebo mean difference: -2.27( 95CI-3.68, -0.87) group after 6 weeks of supplementation.' \[result sourced from clinicaltrials.gov NCT0521254\]
次要结局
- Good Sleeper Scale -15 items (GSS -15) self-reported sleep.(3 timepoints 'Baseline','Endpoint' and 'Follow-up' visits 0,6 and 10 weeks respectivley)
- Depression Anxiety and Stress Scales 42-items (DASS-42) questionnaire. Wellbeing and subjective mental health assessment.(3 timepoints 'Baseline','Endpoint' and 'Follow-up' visits 0,6 and 10 weeks respectivley)
- Faceal microbial sequencing and interventional group microbiota compositional change(Participant home collection, 3 collections:24 hours before 'baseline visit' week 0, 24 hours before 'endpoint visit' week 6, 24 hours before follow-up visit (week 10).)
- Short Food Frequency Questionnaire (SFFQ): Diet quality score(3 timepoints 'Baseline','Endpoint' and 'Follow-up' visits 0,6 and 10 weeks respectivley)
- Activity monitoring using activewear devices(Continuous / 3 nights per 14 days (2 weeknights, 1 weekend night) depending on participants preference.)
- Urine Metabolomics (Untargeted)(Participant home collection, 3 collections:24 hours before 'baseline visit' week 0, 24 hours before 'endpoint visit' week 6, 24 hours before follow-up visit (week 10).)
- Faeces Metabolomics (Untargeted)(Participant home collection, 3 collections:24 hours before 'baseline visit' week 0, 24 hours before 'endpoint visit' week 6, 24 hours before follow-up visit (week 10).)
- Plasma Metabolomics (Untargeted)(3 timepoints 'Baseline','Endpoint' and 'Follow-up' visits 0,6 and 10 weeks respectivley)
- Anthropometrics - Body composition(3 timepoints 'Baseline','Endpoint' and 'Follow-up' visits 0,6 and 10 weeks respectivley)
- Adverse effects monitoring(Continuous monitoring from start to end of study for all participants)