Effect of B. Longum 1714™ on Sleep Quality

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

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.

Study Overview

• Status: Completed
• Conditions: Subjective Sleep Quality; Objective Sleep Quality
• Intervention / Treatment: Dietary supplement: Probiotic capsule; Dietary supplement: Placebo capsule

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).

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Phase 2

Contacts and Locations

Study Locations

• Ireland
  • Cork, Ireland
    • Atlantia Food Clinical Trials Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic capsule; The participants consume one probiotic capsule a day for 8 weeks	Dietary supplement: Probiotic 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.
Placebo Comparator: Placebo capsule; The participants consume one placebo capsule a day for 8 weeks	Dietary supplement: Placebo capsule; Each placebo capsule contains corn starch and magnesium stearate. The placebo capsules will be supplied by PrecisionBiotics Ltd.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in objective sleep quality, specifically sleep latency	Assessed by actigraph	Change from baseline, assessed at 4 and 8 weeks of supplement intake
Change in objective sleep quality, specifically sleep efficiency	Assessed by actigraph	Change from baseline, assessed at 4 and 8 weeks of supplement intake
Change in objective sleep quality, specifically wake episodes	Assessed by actigraph	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	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.	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	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.	Change from baseline, assessed at 4 and 8 weeks of supplement intake

Collaborators and Investigators

• Sponsor: PrecisionBiotics Group Ltd.
• Collaborators: Nottingham Trent University; Atlantia Food Clinical Trials Ltd.
• Investigators: Study Director: Eileen Murphy, PhD, PrecisionBiotics Group Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Actual): April 3, 2020
• Study Completion (Actual): June 23, 2020

Study Registration Dates

• First Submitted: November 15, 2019
• First Submitted That Met QC Criteria: November 15, 2019
• First Posted (Actual): November 18, 2019

Study Record Updates

• Last Update Posted (Actual): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 29, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: probiotic; sleep quality; actigraphy; sleep efficiency; Bifidobacterium longum 1714™; sleep latency; PSQI
• Other Study ID Numbers: AFCRO-108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No