Effects of Postbiotics on Mood Disorders in Korean Adults

NCT06982599 | Active Not Recruiting

• 2 other identifiers: POST-LB-KRHYUIRB-202503-008
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted to investigate effects of postbiotics on mood disorders in korean adults

Conditions

Mood Disorder

Keywords

mood disorder; postbiotics

Outcome Measures

Primary Outcomes (3)

• Effect of postbiotics on depressive symptoms measured by the Center for Epidemiologic Studies Depression Scale (CES-D), compared with placebo

  Epidemiology Research Center Depression Scale (CES-D): The Center for Epidemiologic Studies Depression Scale (CES-D) is a widely used 20-item self-reported instrument designed to measure depressive symptom severity in the general population. Each item is rated on a 4-point scale (0 to 3), assessing emotional, somatic, interpersonal, and positive affect domains over the past week. Total scores range from 0 to 60, with higher scores indicating more severe depressive symptoms.

  week 0, week 8

• Effect of postbiotics on momentary mood measured by Ecological Momentary Assessment (EMA), compared with placebo

  Ecological Momentary Assessment (EMA) captures real-time mood states by sending brief questionnaires to participants multiple times per day via online links. Each assessment includes six questions related to current mood and mental state, scored on a continuous slider scale from 0 (not at all) to 100 (very much). Higher scores indicate greater severity of negative mood or emotional distress. The average daily score will be calculated and used to assess change from baseline.

  Three consecutive days at baseline (Week 0) and three consecutive days at follow-up (Week 8)

• Effect of postbiotics on psychological distress measured by the Depression Anxiety Stress Scale-21 (DASS-21), compared with placebo

  The Depression Anxiety Stress Scale (DASS-21) is a validated self-report tool containing 21 items, divided equally into three subscales: depression, anxiety, and stress. Each item is rated on a 4-point scale (0 to 3), and subscale scores are summed. Each subscale score ranges from 0 to 21, with higher scores indicating more severe symptoms in the respective domain.

  week 0, week 8

Secondary Outcomes (4)

• Effect of postbiotics on perceived stress measured by the Perceived Stress Scale (PSS), compared with placebo

  Week 0, Week 8

• Effect of postbiotics on fecal microbiome composition, compared with placebo

  Week 0, Week 8

• Effect of postbiotics on fecal metabolites, compared with placebo

  Week 0, Week 8

• Effect of postbiotics on gastrointestinal symptoms measured by the Irritable Bowel Syndrome Visual Analog Scale (VAS-IBS), compared with placebo

  Weekly from Week 0 to Week 8

Study Arms (2)

postbiotics

EXPERIMENTAL

3 capsules/day postbiotics (20 × 10\^9 CFU/day) for 8 weeks

Dietary Supplement: postbiotics

Placebo

PLACEBO COMPARATOR

3 capsules/day placebo for 8 weeks

Dietary Supplement: placebo

Interventions

postbiotics DIETARY_SUPPLEMENT

3 capsules/day postbiotics (20 × 10\^9 CFU/day) for 8 weeks

postbiotics

placebo DIETARY_SUPPLEMENT

3 capsules/day placebo for 8 weeks

Placebo

Eligibility Criteria

• Age: 19 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged between 19 and 39 years at the time of screening.
• BMI between 18.5 and 30 at the time of screening.
• CES-D (Center for Epidemiologic Studies Depression Scale) score of 16 or higher.
• Ability to access and respond to the survey via an online link.

You may not qualify if:

• Participation in any human clinical trial within the past 3 months before screening.
• History of antipsychotic medication treatment within the past 3 months before screening.
• Presence of chronic diseases, including cardiovascular, endocrine, immune, respiratory, hepatobiliary, renal and urological, neurological, musculoskeletal, inflammatory, hematological, oncological, or gastrointestinal disorders.
• Use of medications or health supplements related to gut health and mood disorders (e.g., antibiotics, laxatives, antidiarrheals, prebiotics, probiotics, postbiotics, anxiolytics, antidepressants, etc.) within 1 month prior to participation in the study.
• History of significant hypersensitivity to postbiotics or starch.
• Alcohol addiction, drug abuse, or suspicion of substance misuse.
• Pregnant or breastfeeding women.
• Any other reasons that the study investigator deems the participant unsuitable for participation.

Sponsors & Collaborators

• Hanyang University: lead
• DSM-Firmenich AG: collaborator

Study Sites (1)

Hanyang University

Seoul, Seoul, 04763, South Korea

Location

MeSH Terms

Conditions

Mood Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 21, 2025
• Study Start: October 13, 2025
• Primary Completion: December 21, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)