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Novel Objective Digital Biomarkers for Assessing Sub-clinical Mood Disturbances in the Singaporean Population

NCT06115590 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-08-16

No results posted yet for this study

Summary

The investigators aim to assess the relationship between objectives markers (of physiological reactivity) recorded using a smartwatch and self-reported subjective outcomes measured using standardized and non-standardized questionnaires recorded in an eDiary; with stress as the model for our assessment utilizing the validated PSS-10 questionnaire.

As personal characteristics such as personality traits, resilience, and grit have been shown to modulate reactivity and mental health status, the investigators aim to explore the modulation of the study outcomes by such personality factors. Furthermore, the investigators aim to explore the association of the study outcomes with the composition and functional potential of the gut microbiome.

Finally, the investigators aim to explore the effects of a nutritional intervention on our outcome measures.

Participants will participate in a decentralized, parallel-group study with a mixed design lasting 8 days (excluding screening and enrollment). A total of 120 participants are divided into low-stress(n=40), and elevated-stress groups (n=80) based on their perceived stress score (PSS-10, cut-off score 13). A subgroup of elevated-stress participants (n=40) will be administered a nutritional intervention for 3 days. Their responses will be compared to another subgroup of elevated-stress participants (n=40) without intervention.

Conditions

  • Mood

Interventions

DIETARY_SUPPLEMENT

Nutritional supplement

Nutritional intervention hypothesized to have an acute anxiolytic effect

Sponsors & Collaborators

  • OBVIO HEALTH USA, Inc.

    collaborator UNKNOWN

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-08-24
Primary Completion
2024-02-18
Completion
2024-02-18

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 NCT06115590 on ClinicalTrials.gov