Objective Sleep Quality Clinical Trial
Official title:
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
| Verified date | June 2020 |
| Source | PrecisionBiotics Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 89 |
| Est. completion date | June 23, 2020 |
| Est. primary completion date | April 3, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 45 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Ireland | Atlantia Food Clinical Trials Ltd. | Cork |
| Lead Sponsor | Collaborator |
|---|---|
| PrecisionBiotics Ltd. | Atlantia Food Clinical Trials Ltd., Nottingham Trent University |
Ireland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in subjective sleep quality, assessed by Pittsburgh Sleep Quality Index global score | Minimum score is 0, maximum score is 21. Higher scores indicate worse sleep quality. | Change from baseline, assessed at 4 and 8 weeks of supplement intake | |
| Secondary | Change in objective sleep quality, specifically sleep latency | Assessed by actigraph | Change from baseline, assessed at 4 and 8 weeks of supplement intake | |
| Secondary | Change in objective sleep quality, specifically sleep efficiency | Assessed by actigraph | Change from baseline, assessed at 4 and 8 weeks of supplement intake | |
| Secondary | Change in objective sleep quality, specifically wake episodes | Assessed by actigraph | Change from baseline, assessed at 4 and 8 weeks of supplement intake | |
| Secondary | Change in objective sleep quality, specifically wake time after sleep onset (WASO) | Assessed by actigraph | Change from baseline, assessed at 4 and 8 weeks of supplement intake | |
| Secondary | Change in subjectively reported sleep quality, sleep latency, and sleep efficiency | 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. | Change from baseline, assessed at 4 and 8 weeks of supplement intake | |
| Secondary | Change in daily sleep diaries | Assess waking refreshed, night time waking and sleep quality | Change from baseline, assessed daily during 8 weeks of supplement intake | |
| Secondary | Change in daytime sleepiness, assessed by Epworth Sleepiness Scale | Minimum score is 0, maximum score is 24. Higher scores indicate higher daytime sleepiness. | Change from baseline, assessed at 4 and 8 weeks of supplement intake |