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Post-biotic Intervention for Acute Stress Management

NCT06097182 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2024-08-16

No results posted yet for this study

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.

Conditions

  • Stress Response
  • Mood State
  • Sleep
  • Cognition

Interventions

DIETARY_SUPPLEMENT

Post-biotic (Colonic-Delivery capsule)

250mg post-biotic once daily in a polymer coated vegan gelatine capsule (colonic delivery)

DIETARY_SUPPLEMENT

Post-biotic (Regular Administration capsule)

250mg post-biotic once daily in a regular uncoated vegan gelatine capsule

OTHER

Placebo

250mg Maltodextrin once daily in a regular uncoated vegan gelatine capsule

Sponsors & Collaborators

  • Institute for Human Development and Potential (IHDP), Singapore

    lead OTHER

Principal Investigators

  • Jeroen Schmitt, PhD · Singapore Institute of Clinical Sciences (SICS), A*STAR

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
30 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2024-06-14
Completion
2024-06-14

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06097182 on ClinicalTrials.gov