Evaluating the Effects of Nutritional Interventions on Sleep, the Gut Microbiome, Cognition, and Stress Following 28 Days Consumption in Adults Reporting Sub-clinical Sleep Deficits: A Randomised, Double-blind, Placebo-controlled, Three-arm Parallel Groups Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Sleep Efficiency (SE)
研究概览
简要总结
This will be a double-blind, placebo-controlled, parallel-group trial. Participants who are poor sleepers will be randomised to receive one of two investigational supplements, or a placebo control supplement, over a 28-day period. At baseline and following 28 days of consumption, sleep quality, gut microbiome profiles, cognitive performance, and mood will be assessed. Sleep outcome measures will also be assessed throughout the supplementation period to monitor the time course of any observed changes. A final data set of at least 66 participants is expected.
详细描述
This will be a double-blind, placebo-controlled, parallel-group trial. Participants who are poor sleepers will be randomised to receive one of two investigational supplements, or a placebo control supplement, over a 28-day period. At baseline and following 28 days of consumption, sleep quality, gut microbiome profiles, cognitive performance, and mood will be assessed. Sleep outcome measures will also be assessed throughout the supplementation period to monitor the time course of any observed changes. A final data set of at least 66 participants is expected.
Interested participants will initially be scheduled to complete a screening telephone call with the researcher. Here, electronic informed consent will first be provided by the participant, by accessing a pre-emailed link to the Qualtrics survey platform, to an account which is hosted by Northumbria University. Once consent is obtained, the participant will confirm that they do not meet any of the study exclusion criteria, and will complete the SDS-CL checklist with the researcher, over the phone. If any clinical thresholds are met, participants will be invited to a separate clinical interview (again via phonecall) with Professor Jason Ellis, employing the International Classification of Sleep Disorders (ICSD-3) criteria, to determine elligibility.
If participants progress to enrolment, they will be invited to attend a lab-based training/screening session (protocol day -7) at Northumbria University. Here, hard and wet-signed (by both the participant and the researcher) consent forms will be completed and stored on site. Participants will then be familiarised with the study protocol and procedures. Participants will also be trained on the cognitive tasks. During the following 7 nights (Protocol days -7 to -1), participants will monitor their sleep and complete the daily Sleep Diary each morning. During this week, they will also drop off their pre-dose baseline stool sample at a remote drop-off location at Northumbria University.
Seven days following the lab-based screening visit (Supplement day 1, Protocol day 0), participants will attend the laboratory for their acute visit. Here, a pre-dose baseline sample of saliva and a single blood sample will be taken (for Alpha Amylase, Cortisol, Serotonin and Melatonin), and Blood Pressure, Heart Rate, Body Mass Index, and Waist-to-Hip Ratio will be measured. Participants will complete the Intake24 dietary assessment, and gastrointestinal symptoms questionnaires, as well as the Pittsburgh Sleep Quality Index (PSQI), State-Trait Anxiety Inventory (STAI), and Depression, Anxiety and Stress Scale - 21 Items (DASS-21). The cognitive task battery will additionally be completed.
After completing these measures, participants will receive instructions on the next phase of the trial. From that night, participants will consume their first dose of the investigational supplement (noting the time in their treatyment diary) 4 hours before their normal bed-time. They will monitor their sleep overnight. The following morning (supplementation day 2, protocol day 1), participants will complete their Sleep Diary. Participants will follow this procedure for the following 27 days. At some point during Protocol (Days 12-18), participants will return to Northumbria University to drop-off their interim stool sample.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must self-assess themselves as being in good health.
- •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 nutritional supplements.
- •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 (descriptions will be given)
- •Current misuse of alcohol and/or drugs
- •Current smoker
- •Recent (within the last 12 weeks) infection and/or use of antibiotic medication
- •Pregnant, seeking to become pregnant or lactating
- •Those using (including within the last 2 weeks) proton-pump inhibitors
研究组 & 干预措施
Arm 1
Participants will be randomly allocated to consume investigational supplement (1 of 2 proprietary 'active' compositions) for 28 days.
干预措施: Proprietary 'active' composition 1 (Dietary Supplement)
Arm 2
Participants will be randomly allocated to consume investigational supplement (1 of 2 proprietary 'active' compositions) for 28 days.
干预措施: Proprietary 'active' composition 2 (Dietary Supplement)
Control
Participants will be randomly allocated to consume control supplement for 28 days.
干预措施: Inactive control supplement (Dietary Supplement)
结局指标
主要结局
Sleep Efficiency (SE)
时间窗: Change from Baseline to end of supplementation period at 28 days
Sleep efficiency (SE), commonly defined as the ratio of total sleep time (TST) to time in bed (TIB), will be reported as a percentage of time in bed.
次要结局
- Actigraphy - Sleep onset latency(Change from baseline following 28 days of supplement consumption)
- Actigraphy - Sleep efficiency(Change from baseline following 28 days of supplement consumption)
- Actigraphy - Number of awakenings(Change from baseline following 28 days of supplement consumption)
- Actigraphy - Wake after sleep onset (WASO)(Change from baseline following 28 days of supplement consumption)
- COMPASS global performance measures(Change from baseline following 28 days of supplement consumption)
- Pittsburgh Sleep Quality Index (PSQI)(Change from baseline following 28 days of supplement consumption)
- Depression, Anxiety and Stress Scale - 21 Items (DASS-21)(Change from baseline following 28 days of supplement consumption)
- State-Trait Anxiety Inventory (STAI)(Change from baseline following 28 days of supplement consumption)
- Actigraphy - Total sleep time(Change from baseline following 28 days of supplement consumption)
- Sleep Diary - Total sleep time(Change from baseline following 28 days of supplement consumption)
- Sleep Diary - Sleep onset latency(Change from baseline following 28 days of supplement consumption)
- Sleep Diary - Sleep efficiency(Change from baseline following 28 days of supplement consumption)
- Sleep Diary - Number of awakenings(Change from baseline following 28 days of supplement consumption)
- Sleep Diary - Wake after sleep onset (WASO)(Change from baseline following 28 days of supplement consumption)