Objective Sleep Quality, Subjective Sleep Quality
Conditions
Keywords
Bifidobacterium longum 1714™, probiotic, sleep quality, PSQI, actigraphy, sleep latency, sleep efficiency
Brief summary
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.
Detailed description
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).
Interventions
DIETARY_SUPPLEMENTProbiotic capsule
Each probiotic capsule contains 1 x 10\^9 CFU B. longum 1714™ with corn starch and magnesium stearate. The probiotic capsules will be supplied by PrecisionBiotics Ltd.
DIETARY_SUPPLEMENTPlacebo capsule
Each placebo capsule contains corn starch and magnesium stearate. The placebo capsules will be supplied by PrecisionBiotics Ltd.
Sponsors
Nottingham Trent University
Atlantia Food Clinical Trials
PrecisionBiotics Group Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Provide written informed consent 2. Age: 18 to 45 years of age 3. BMI \< 29.9 kg/m2 4. Be willing to refrain from taking any dietary supplements or other fermented foods that contain live bacteria during the study 5. Be willing to refrain from taking any medications or preparations to improve sleep (herbal, dietary supplements, homeopathic preparations, etc.) during the study 6. If using products that contain nicotine or caffeine, agrees to continue current usage levels throughout the length of the study 7. Agrees not to undertake air travel exceeding two time zones during the period of the study 8. PSQI score of 5 and above 9. HADS-A and HADS-D score of 14 and below 10. ISI score below 11 11. Be willing to maintain stable dietary habits and physical activity levels throughout the study period 12. 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
Exclusion criteria
1. Less than 18 or older than 45 years of age at the time of consent 2. Use of dietary supplements or other fermented foods that contain live bacteria 3. Participant who has been on antibiotics during the past 3 months 4. 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 5. 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 6. Participant with inflammatory disorders (e.g. chronic fatigue syndrome, psoriasis, rheumatoid arthritis or any other inflammatory arthropathies) 7. Psychiatric diagnosis other than anxiety or depression 8. 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) 9. 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) 10. Combined SF36 score of greater than +2 SD from the mean 11. Participants with a history of drug and /or alcohol abuse at the time of enrolment 12. Pregnant or lactating female, or pregnancy planned during study period 13. Participants who have undertaken air travel involving transit across two or more time zones in the month previous to the study 14. Participants who are shift workers 15. Participants with sleep disorders diagnosed by a physician such as sleep apnoea; 16. Known allergy to any of the components of the test product 17. History of illicit drug use 18. 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 19. Participant has a history of non-compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in subjective sleep quality, assessed by Pittsburgh Sleep Quality Index global score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in objective sleep quality, specifically sleep efficiency | Change from baseline, assessed at 4 and 8 weeks of supplement intake | Assessed by actigraph |
| Change in objective sleep quality, specifically wake episodes | Change from baseline, assessed at 4 and 8 weeks of supplement intake | Assessed by actigraph |
| Change in objective sleep quality, specifically wake time after sleep onset (WASO) | Change from baseline, assessed at 4 and 8 weeks of supplement intake | Assessed by actigraph |
| Change in objective sleep quality, specifically sleep latency | Change from baseline, assessed at 4 and 8 weeks of supplement intake | Assessed by actigraph |
| Change in daily sleep diaries | Change from baseline, assessed daily during 8 weeks of supplement intake | Assess waking refreshed, night time waking and sleep quality |
| Change in daytime sleepiness, assessed by Epworth Sleepiness Scale | Change from baseline, assessed at 4 and 8 weeks of supplement intake | Minimum score is 0, maximum score is 24. Higher scores indicate higher daytime sleepiness. |
| Change in subjectively reported sleep quality, sleep latency, and sleep efficiency | Change from baseline, assessed at 4 and 8 weeks of supplement intake | Assessed by Pittsburgh Sleep Quality Index (PSQI) subscales. Each component has a minimum score of 0, maximum score of 3. Higher scores mean worse outcome. |
Countries
Ireland
Outcome results
None listed