Status:
COMPLETED
Post-biotic Intervention for Acute Stress Management
Lead Sponsor:
Institute for Human Development and Potential (IHDP), Singapore
Conditions:
Stress Response
Mood State
Eligibility:
MALE
21-30 years
Phase:
NA
Brief 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 stres...
Detailed Description
Scientific findings over the past years suggest that certain bacteria in our gastrointestinal system have an influence on our mood, although, the mechanisms are not yet well understood. One of the pos...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2024
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06097182
Start Date
November 1 2023
End Date
June 14 2024
Last Update
August 16 2024
Active Locations (1)
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1
Human Development Research Centre, SICS, A*STAR
Singapore, Singapore, 117597