None listed
Conditions
Brief summary
Recent research suggests that probiotics or paraprobiotics may be a possible option for preventing insomnia or increased stress levels. Probiotics are live microorganisms that can lead to health benefits when consumed in adequate amounts. Paraprobiotics are probiotic cells that have been ‘inactivated’ (e.g., no longer live) that provide similar health benefits to probiotics. Consuming probiotics or paraprobiotics may restore the balance of helpful and harmful microbes in the gut, and some studies show they improve sleep quality and stress levels, possibly by changing the production of hormones and neurotransmitters by gut cells that are responsible for sleep patterns. For this study, we will compare the effects of consuming a paraprobiotic over eight weeks, on sleep quality, stress levels and the gut microbiome, in New Zealanders who suffer from insomnia and high stress levels.
Interventions
The intervention consists of tablets containing heat-inactivated Lactobacullus sp. (1 x 10^10 bacterial cells per two tablets). The active tablet will be composed of maltose, dextrin, starch, heat-inactivated lactic acid bacteria powder, and vegetable oil.
The study duration is a nominal total of 12 weeks, with a two-week lead-in phase, eight-week intervention phase, and follow-up two-weeks after the end of the intervention.
The 2-weeks lead-in phase requires participants to complete weekly ques
The intervention consists of tablets containing heat-inactivated Lactobacullus sp. (1 x 10^10 bacterial cells per two tablets). The active tablet will be composed of maltose, dextrin, starch, heat-inactivated lactic acid bacteria powder, and vegetable oil. The study duration is a nominal total of 12 weeks, with a two-week lead-in phase, eight-week intervention phase, and follow-up two-weeks after the end of the intervention. The 2-weeks lead-in phase requires participants to complete weekly questionnaires about their sleep patterns, and record their bowel motion, mood, and perception of sleep quality every day on an app designed for this trial. During the second week of the lead-in period they will complete a non-consecutive 3-day food diary, wear an actigraphy device for seven days to measure sleep and activity levels, and wear an electroencephalogram headband for three nights (at their home) to measure brainwave patterns during sleep. Participants will collect a faecal and saliva sample one day prior to their baseline visit (end of 2nd week of lead-in phase). At their baseline visit (beginning of intervention phase) participants will have height and weight measured, complete a set of questionnaires about their mental and physical health, general well-being, and clinical variables. During the eight-week intervention phase, participants will consume two of their assigned tablets each day (with or without water or food), complete their daily bowel motion and mood/sleep app and complete weekly sleep questionnaires and two-weekly mental health questionnaires. The tablets will be packaged in sachets containing two-weeks supply. Compliance will be monitored by checklist and counting returned tablets. Participants will attend the study clinic at weeks 2, 4 and 6 to return unused tablets, and pick up their next two weeks of tablets. At the final clinic visit (end of intervention phase), the aforementioned baseline visit procedures will be repeated. Prior to the final visit, participants will again complete the same set of questionnaires, 7-day actigraph, 3-night EEG, and non-consecutive 3-day food diary, and collect a faecal sample and saliva sample. Participants will receive their reimbursement ($300 grocery vouchers). Attendance of clinic visits and completion of questionnaires will be assessed to measure the adherence of participants. Two-weeks after the final clinic visit, participants will complete an online survey regarding their mental and physical health, general well-being, and gastrointestinal symptoms; the link to this survey will be sent to the participant by email.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
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
Outcome results
None listed