Evaluating the Effects of Prebiotic-based Interventions on Sleep, the Gut Microbiome, Cognition, Immune Function and Stress Following 56 Days Consumption in Healthy Volunteers

Northumbria University2 个研究点分布在 1 个国家目标入组 68 人2022年3月3日

适应症Sleep

干预措施Prebiotic Control

概览

阶段: 不适用
干预措施: Prebiotic
疾病 / 适应症: Sleep
发起方: Northumbria University
入组人数: 68
试验地点: 2
主要终点: Lab-recorded polysomnography- Sleep Quality
状态: 进行中（未招募）
最后更新: 3个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

The aim of the proposed randomised, double-blind, controlled, parallel groups trial is to assess the sleep, gut microbiome, cognitive, immune and stress effects of 56 days administration of three formulations of a prebiotic-based intervention, in comparison to a placebo control, in a cohort of healthy adults reporting poor sleep quality.

注册库

clinicaltrials.gov

开始日期

2022年3月3日

结束日期

2026年12月1日

最后更新

3个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Northumbria University

责任方

Sponsor

入排标准

入选标准

•Participants must self-assess themselves as being in good health.
•Have a stable sleep/wake schedule (bedtime between 9pm and 1am and wake time between 6am and 10am at least 5 nights per week)
•Aged 25 to 60 years at the time of randomisation
•Fluent in English
•Identify as a 'poor sleeper' as defined subjectively (i.e. poor sleep quality, unrefreshing sleep) and a total score of \>5 on the Pittsburgh Sleep Quality Index (PSQI).

排除标准

•Member of own household currently participating in this trial
•Evidence of current or recent sleep disorders (e.g. sleep apnoea, insomnia, circadian rhythm disorders), taking any medication which exerts sedative effects, affects the CNS and/or sleep, or be currently unwell with any illness that affects sleep (i.e. disorders of the CNS). An initial screening for sleep disorders will be conducted using the Sleep Disorders Symptom Checklist-25 (SDS-CL; Klingman et al., 2017). If a participant reports positively to any of the 25 questions in terms of being affected for three nights per week, or more, this will be followed up using a clinical interview according to the International Classification of Sleep Disorders (ICSD-3) to exclude on the basis of a sleep disorder
•History of seizures or epilepsy
•Shift working or have a history of shift work within the previous six months
•Currently, or within the previous 8 weeks, consuming any prebiotic or probiotic products/supplements (including specifically oligosaccharides)
•Participation in any other intervention research trials
•Sleeping at a location other than their usual residence more than two nights per week during participation
•Travel across multiple time zones within the last three months or have planned travel across multiple time zones during the study
•Current or recent mood disturbances or Axis I disorders
•Current misuse of alcohol and/or drugs

研究组 & 干预措施

Investigational Supplement 1 (INV-1)

The total daily supplement to be consumed by participants is 33.0 g. This will be administered as 2 separate doses mixed with water, a 16.5 g dose (two 8.25 g sachets) to be consumed in the morning (AM dose) and a 16.5 g dose (two 8.25 g sachets) to be consumed in the evening (PM dose). Supplementation will last 56 days.

干预措施: Prebiotic

Investigational Supplement 1 (INV-2)

干预措施: Prebiotic

Investigational Supplement 1 (INV-3)

干预措施: Prebiotic

Control

干预措施: Control

结局指标

主要结局

Lab-recorded polysomnography- Sleep Quality

时间窗: Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption

percentage of time in staged sleep from total sleep recorded time

次要结局

Lab-recorded polysomnography- Time spent in stages of rapid eye movement (REM) and non-REM sleep(Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption)
Lab-recorded polysomnography- Sleep onset latency(Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption)
Lab-recorded polysomnography- Total sleep time(Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption)
Lab-recorded polysomnography- Number of awakenings(Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption)
Lab-recorded polysomnography- Wake after sleep onset(Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption)
Lab-recorded polysomnography- REM Rebound(Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption)
Lab-recorded polysomnography- Sleep microstructure(Change from protocol days 2 and 3 (baseline) and 59 and 60 following 56 days of supplement consumption)
Actigraphy - Sleep onset latency(Change from baseline following 56 days of supplement consumption)
Actigraphy - Total sleep time(Change from baseline following 56 days of supplement consumption)
Actigraphy - Number of awakenings(Change from baseline following 56 days of supplement consumption)
Actigraphy - Wake after sleep onset (WASO)(Change from baseline following 56 days of supplement consumption)
Actigraphy - Sleep efficiency(Change from baseline following 56 days of supplement consumption)
Blood Pressure and Heart Rate (BP/HR)(Change from baseline following 56 days of supplement consumption)
Waist-to-Hip Ratio (WHR)(Change from baseline following 56 days of supplement consumption)
Work Productivity and Activity Impairment questionnaire (WPAI)(Change from baseline following 56 days of supplement consumption)
Gastrointestinal symptoms questionnaire(Change from baseline following 56 days of supplement consumption)
Sleep Diary -Sleep Latency(Change from baseline following 56 days of supplement consumption)
Sleep Diary - Wake After Sleep Onset (WASO)(Change from baseline following 56 days of supplement consumption)
Body Mass Index (BMI)(Change from baseline following 56 days of supplement consumption)
Perceived Stress Scale (PSS(Change from baseline following 56 days of supplement consumption)
Sleep Diary -Number of Awakenings(Change from baseline following 56 days of supplement consumption)
Dietary assessment- Intake24(Change from baseline following 56 days of supplement consumption)
Subjective Stress (VAS)(Change from baseline following 56 days of supplement consumption)
Subjective productivity (VAS)(Change from baseline following 56 days of supplement consumption)
Cognitive domain factor score(Change from baseline following 56 days of supplement consumption)
Cognitive Function under stressful conditions(Change from baseline following 56 days of supplement consumption)
Changes in subjective stress; as assessed by the 'state, trait anxiety inventory' (STAI)(Change from baseline following 56 days of supplement consumption)
Pittsburgh Sleep Quality Index (PSQI)(Change from baseline following 56 days of supplement consumption)
Profile of Mood States (POMS)(Change from baseline following 56 days of supplement consumption)
State-Trait Anxiety Inventory (STAI)(Change from baseline following 56 days of supplement consumption)
Depression, Anxiety and Stress Scale - 21 Items (DASS-21)(Change from baseline following 56 days of supplement consumption)
12-Item Short Form Survey (SF-12)(Change from baseline following 56 days of supplement consumption)
Sleep Diary -Total Sleep Time(Change from baseline following 56 days of supplement consumption)
Sleep Diary -Time in bed(Change from baseline following 56 days of supplement consumption)
Sleep Diary - Sleep Efficiency(Change from baseline following 56 days of supplement consumption)
Sleep Diary - Sleep Quality(Change from baseline following 56 days of supplement consumption)
Perceived sleep quality (VAS)(Change from baseline following 56 days of supplement consumption)
Subjective mood (VAS)(Change from baseline following 56 days of supplement consumption)
COMPASS global performance measures(Change from baseline following 56 days of supplement consumption)
Changes in objective stress; as assessed by salivary cortisol levels(Change from baseline following 56 days of supplement consumption)
Changes in objective stress; as assessed by salivary alpha-amylase levels(Change from baseline following 56 days of supplement consumption)
Changes in objective stress; as assessed by galvanic skin response (GSR)(Change from baseline following 56 days of supplement consumption)
Changes in objective stress; as assessed by heart rate (HR)(Change from baseline following 56 days of supplement consumption)
Gut microbiome assessments (gut bacterial profile)(Change from baseline following 56 days of supplement consumption)
Immunological marker Assessment -Blood(Change from baseline following 56 days of supplement consumption)