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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
89
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.
Each placebo capsule contains corn starch and magnesium stearate. The placebo capsules will be supplied by PrecisionBiotics Ltd.
Atlantia Food Clinical Trials Ltd.
Cork, Ireland
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.
Time frame: Change from baseline, assessed at 4 and 8 weeks of supplement intake
Change in objective sleep quality, specifically sleep latency
Assessed by actigraph
Time frame: Change from baseline, assessed at 4 and 8 weeks of supplement intake
Change in objective sleep quality, specifically sleep efficiency
Assessed by actigraph
Time frame: Change from baseline, assessed at 4 and 8 weeks of supplement intake
Change in objective sleep quality, specifically wake episodes
Assessed by actigraph
Time frame: Change from baseline, assessed at 4 and 8 weeks of supplement intake
Change in objective sleep quality, specifically wake time after sleep onset (WASO)
Assessed by actigraph
Time frame: Change from baseline, assessed at 4 and 8 weeks of supplement intake
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.
Time frame: Change from baseline, assessed at 4 and 8 weeks of supplement intake
Change in daily sleep diaries
Assess waking refreshed, night time waking and sleep quality
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Time frame: Change from baseline, assessed daily during 8 weeks of supplement intake
Change in daytime sleepiness, assessed by Epworth Sleepiness Scale
Minimum score is 0, maximum score is 24. Higher scores indicate higher daytime sleepiness.
Time frame: Change from baseline, assessed at 4 and 8 weeks of supplement intake