A Randomised, Double-blinded, Placebo-controlled, Parallel-group, Pilot Study to Assess the Effectiveness of the B. Longum 1714™ Strain on Subjective and Objective Sleep Quality in Healthy Men and Women
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Change in subjective sleep quality, assessed by Pittsburgh Sleep Quality Index global score
研究概览
简要总结
The aim of this study is to evaluate the effect of supplementation with the B. longum 1714™ strain on subjective and objective sleep quality in healthy participants.
详细描述
This is a randomized, double-blind, placebo-controlled, parallel group study, designed to assess the effectiveness & safety of the B. longum 1714™ strain, when consumed once daily, on sleep quality. The 8-week intervention study will be conducted in otherwise healthy participants with a Pittsburgh Sleep Quality Index (PSQI) score of greater than, or equal to 5, a HADS-A and HAD-D score less than or equal to 14 and an Insomnia Severity Index of less than 11. Participants (N=90) will be pre-screened online, then visit the study site 4 times during the course of the 8 - 10 weeks' study (2 weeks screening period, followed by 8-week intervention). The first visit will be for screening, second visit will be baseline (and start of intervention - either active or placebo), third visit will be mid-intervention, and fourth visit will be at the end of intervention. Questionnaires will be administered at visit 2, 3 and 4, and research blood and saliva will also be collected at these time points. Hair sample will be taken at visit 2 and 4 while stool sample will be collected at visit 4. Participants will wear an actigraph and fill in a sleep eDiary for the whole intervention period (from visit 2 to visit 4).
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Provide written informed consent
- •Age: 18 to 45 years of age
- •BMI < 29.9 kg/m2
- •Be willing to refrain from taking any dietary supplements or other fermented foods that contain live bacteria during the study
- •Be willing to refrain from taking any medications or preparations to improve sleep (herbal, dietary supplements, homeopathic preparations, etc.) during the study
- •If using products that contain nicotine or caffeine, agrees to continue current usage levels throughout the length of the study
- •Agrees not to undertake air travel exceeding two time zones during the period of the study
- •PSQI score of 5 and above
- •HADS-A and HADS-D score of 14 and below
- •ISI score below 11
- •Be willing to maintain stable dietary habits and physical activity levels throughout the study period
- •Be able to communicate well with the Investigator, to understand and comply with the requirements of the study and be judged suitable for the study in the opinion of the Investigator
排除标准
- •Less than 18 or older than 45 years of age at the time of consent
- •Use of dietary supplements or other fermented foods that contain live bacteria
- •Participant who has been on antibiotics during the past 3 months
- •Participant with a malignant disease or any concomitant end-state organ disease and/or laboratory abnormalities considered by Investigators to be risky or that could interfere with data collection
- •Participant who has a significant acute or chronic coexisting illness [cardiovascular, history of co-existing gastrointestinal, and/or gynaecological, and/or urologic pathology (e.g. colon cancer, colitis, Crohn's, celiac, IBS, endometriosis, prostate cancer) or lactose intolerance
- •Participant with inflammatory disorders (e.g. chronic fatigue syndrome, psoriasis, rheumatoid arthritis or any other inflammatory arthropathies)
- •Psychiatric diagnosis other than anxiety or depression
- •Participant who is severely immunocompromised (HIV positive, transplant patient, on antirejection medications, on a steroid for >30 days, or chemotherapy or radiotherapy within the last year)
- •Participants who are on anxiolytics, anti-depressants, antipsychotics, anticonvulsants, centrally acting corticosteroids, opioid pain relievers, hypnotics, and/or prescribed sleep medication/ herbals (e.g. valerian)
- •Combined SF36 score of greater than +2 SD from the mean
- •Participants with a history of drug and /or alcohol abuse at the time of enrolment
- •Pregnant or lactating female, or pregnancy planned during study period
- •Participants who have undertaken air travel involving transit across two or more time zones in the month previous to the study
- •Participants who are shift workers
- •Participants with sleep disorders diagnosed by a physician such as sleep apnoea;
- •Known allergy to any of the components of the test product
- •History of illicit drug use
- •Participation in a clinical study with an investigational product within 60 days before screening, or plans to participate in another study during the study period
- •Participant has a history of non-compliance
结局指标
主要结局
Change in subjective sleep quality, assessed by Pittsburgh Sleep Quality Index global score
时间窗: Change from baseline, assessed at 4 and 8 weeks of supplement intake
Minimum score is 0, maximum score is 21. Higher scores indicate worse sleep quality.
次要结局
- Change in objective sleep quality, specifically wake time after sleep onset (WASO)(Change from baseline, assessed at 4 and 8 weeks of supplement intake)
- Change in objective sleep quality, specifically wake episodes(Change from baseline, assessed at 4 and 8 weeks of supplement intake)
- Change in objective sleep quality, specifically sleep efficiency(Change from baseline, assessed at 4 and 8 weeks of supplement intake)
- Change in daily sleep diaries(Change from baseline, assessed daily during 8 weeks of supplement intake)
- Change in daytime sleepiness, assessed by Epworth Sleepiness Scale(Change from baseline, assessed at 4 and 8 weeks of supplement intake)
- Change in objective sleep quality, specifically sleep latency(Change from baseline, assessed at 4 and 8 weeks of supplement intake)
- Change in subjectively reported sleep quality, sleep latency, and sleep efficiency(Change from baseline, assessed at 4 and 8 weeks of supplement intake)