Investigating the effect of a paraprobiotic on sleep quality, stress, and gut health in people with insomnia and elevated stress levels

Not Applicable

Recruiting

• Conditions: Insomnia; Stress; Gastrointestinal health; Mental Health - Other mental health disorders; Mental Health - Anxiety; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12623000373673
• Lead Sponsor: niversity of Otago

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-04-13
• Last Update Posted: 21 June 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

To be eligible to participate, people must meet both 1 and 2 of the following inclusion criteria:
1)Experiencing sleep disturbances (difficulty getting to sleep, and/or staying asleep and/or waking too early over the last three months).
2)Experiencing elevated stress

Exclusion Criteria

- having a current clinical diagnosis of a sleep disorder (such as sleep apnea, sleep movement disorder or narcolepsy) or have had a recent major depressive episode or clincal diagnosis of schizophrenia, manic-depression or bipolar disorder
- taking prescribed medications for a sleep disorder or psychiatric disorder
- taken antibiotics wihtin the month before starting the trial
- medical history of severe gastrointestinal disorder (such as inflammatory bowel disease, coeliac disease) or clinically significant medical condition
- taking prescribed medications such as opioid pain killers, non-steroidal anti-inflammatory drugs
- are pregnant or lactating
- are current smokers
- have excessive alcohol intake (>21 standard drinks a week)
- unwilling to avoid probiotic or prebiotic supplements, or foods/beverages containing high levels of live lactic acid bacteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in self-reported sleep quality, measured by Pittsburgh Sleep Quality Index global score[Baseline (beginning of intervention phase) and end of intervention (week 8)]