Effect of B. Longum 1714™ on Sleep Quality

NCT ID: NCT04167475

Last Updated: 2020-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-06
• Study Completion Date: 2020-06-23

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).

Conditions

Subjective Sleep Quality; Objective Sleep Quality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Probiotic capsule

The participants consume one probiotic capsule a day for 8 weeks

Group Type: EXPERIMENTAL

Probiotic capsule

Intervention Type: DIETARY_SUPPLEMENT

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 capsule

The participants consume one placebo capsule a day for 8 weeks

Group Type: PLACEBO_COMPARATOR

Placebo capsule

Intervention Type: DIETARY_SUPPLEMENT

Each placebo capsule contains corn starch and magnesium stearate. The placebo capsules will be supplied by PrecisionBiotics Ltd.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo capsule

Each placebo capsule contains corn starch and magnesium stearate. The placebo capsules will be supplied by PrecisionBiotics Ltd.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nottingham Trent University

OTHER

Sponsor Role: collaborator

Atlantia Food Clinical Trials

INDUSTRY

Sponsor Role: collaborator

PrecisionBiotics Group Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eileen Murphy, PhD

Role: STUDY_DIRECTOR

PrecisionBiotics Group Ltd.

Locations

Atlantia Food Clinical Trials Ltd.

Cork, , Ireland

Countries

Ireland

References

Patterson E, Tan HTT, Groeger D, Andrews M, Buckley M, Murphy EF, Groeger JA. Bifidobacterium longum 1714 improves sleep quality and aspects of well-being in healthy adults: a randomized, double-blind, placebo-controlled clinical trial. Sci Rep. 2024 Feb 14;14(1):3725. doi: 10.1038/s41598-024-53810-w.

Reference Type: DERIVED

PMID: 38355674 (View on PubMed)

Other Identifiers

AFCRO-108

Identifier Type: -

Identifier Source: org_study_id