Post-biotic Intervention for Acute Stress Management
Singapore75 participantsStarted 2023-11-01
Plain-language summary
The study aims to evaluate the sub-chronic effects of colonic delivery of a post-biotic on stress response, mood state, sleep, and cognition in healthy young subjects with elevated self-reported stress levels. It is hypothesized that oral intake of the post-biotic, when released in the colonic intestinal site, leads to a blunted subjective and objective stress response after a stress induction.
Who can participate
Age range21 Years – 30 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 21 to 30 years
* Men
* Perceived Stress Scale (PSS-10) score \>13
* Own and uses a smartphone that is capable to run the study applications with access to the internet
* Adequate fluency in the English language to understand the inform consent process, study instructions and study assessments
* Sufficient vision and hearing to complete study procedures
* Willing to commit to the study procedures
* Willing and able to participate and to give written informed consent All inclusion criteria will be assessed based on self-reported information during the screening visit.
Exclusion Criteria:
* Past (\< 6 months prior to the study) or current major neurological, psychiatric, gastrointestinal, metabolic disease or cardiovascular disease
* Past (\<1 months prior to the study) or current use of psychoactive medication, cardiovascular medication, or corticosteroids.
* Known medical history of hypotension or currently on antihypertensive medication
* Alcohol intake \>1 units day
* Present or past history of alcohol or drug addiction and/or recreational drug use
* BMI \<18.5 or \>25 kg/m2
* Maltodextrin allergy
* Members of the research team or their immediate family members. An immediate family member is defined as spouse, parent, child, or sibling, whether biological or legally adopted All exclusion criteria will be assessed based on self-reported information during the screening call.
What they're measuring
1
Salivary Cortisol
Timeframe: Day 7 (5/day)
Trial details
NCT IDNCT06097182
SponsorInstitute for Human Development and Potential (IHDP), Singapore