Post-biotic Intervention for Acute Stress Management

NCT06097182 | Completed

• 1 other identifier: 2023-086
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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 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

Keywords

gut-brain-axis; stress response; Cognition; Mood State; Sleep

Outcome Measures

Primary Outcomes (1)

• Salivary Cortisol

  cortisol levels, as a marker of hypothalamic-pituitary-adrenal (HPA) axis activation

  Day 7 (5/day)

Secondary Outcomes (4)

• State Trait Anxiety Inventory (STAI-6)

  Day 7 (2/day)

• The Brunel Mood Scale (BRUMS)

  Day 7 (2/day)

• Heart Rate

  Days 1-7

• Sleep Activity

  Days 1-7

Other Outcomes (10)

• Ecological Momentary Assessments (EMA)

  Day 1-6 (4/day), Day 7 (2/day), Day 8 (1/day)

• Salivary α-amylase

  Day 7 (5/day)

• Gastrointestinal Symptoms

  Days 1-7 (1/day)

Study Arms (3)

Post-biotic, colonic delivery

EXPERIMENTAL

n=25, 250mg post-biotic once daily in a polymer coated vegan gelatine capsule (colonic delivery)

Dietary Supplement: Post-biotic (Colonic-Delivery capsule); Other: Placebo

Post-biotic, regular administration

ACTIVE COMPARATOR

n=25, 250mg post-biotic once daily in a regular uncoated vegan gelatine capsule

Dietary Supplement: Post-biotic (Regular Administration capsule); Other: Placebo

Placebo

PLACEBO COMPARATOR

n=25, 250mg Maltodextrin once daily in a regular uncoated vegan gelatine capsule

Other: Placebo

Interventions

Post-biotic (Colonic-Delivery capsule) DIETARY_SUPPLEMENT

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

Post-biotic, colonic delivery

Post-biotic (Regular Administration capsule) DIETARY_SUPPLEMENT

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

Post-biotic, regular administration

Placebo OTHER

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

Placebo; Post-biotic, colonic delivery; Post-biotic, regular administration

Eligibility Criteria

• Age: 21 Years - 30 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Human Development Research Centre, SICS, A*STAR

Singapore, 117597, Singapore

Location

Related Publications (1)

• Boets E, Gomand SV, Deroover L, Preston T, Vermeulen K, De Preter V, Hamer HM, Van den Mooter G, De Vuyst L, Courtin CM, Annaert P, Delcour JA, Verbeke KA. Systemic availability and metabolism of colonic-derived short-chain fatty acids in healthy subjects: a stable isotope study. J Physiol. 2017 Jan 15;595(2):541-555. doi: 10.1113/JP272613. Epub 2016 Sep 18.

  PMID: 27510655 BACKGROUND

MeSH Terms

Conditions

Fractures, Stress

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Officials

• Jeroen Schmitt, PhD

  Singapore Institute of Clinical Sciences (SICS), A*STAR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Principal Scientist

Model Details: Study design: The study will be carried out according to a randomized, placebo-controlled, double-blind, 3 arm parallel-groups design. It will be executed as a hybrid study (partially decentralized). Total study duration is 9 days (day 0 to day 8), excluding screening and enrolment.

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 24, 2023
• Study Start: November 1, 2023
• Primary Completion: June 14, 2024
• Study Completion: June 14, 2024
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)