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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
120
Nutritional intervention hypothesized to have an acute anxiolytic effect
Singapore Institute for Clinical Trials
Singapore, Singapore
Depression Anxiety and Stress Scale 21 (DASS-21)
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self- report scales designed to measure the emotional states of depression, anxiety and stress in clinical and non-clinical populations. Each of the three DASS-21 scales contains 7 items that are scored on a 4-point Likert scale (0-3). In the current study a modified version is used where subjects rate their symptoms over the past 24 hours, rather than 1 week. This questionnaire will be completed daily at 9 pm.
Time frame: 7 days
State Trait Anxiety Inventory (STAI-6) 23
The STAI-6 is a validated short-form version (6 items) of the 40-item STAI questionnaire, measuring current anxiety symptoms on a 4-point Likert scale. Total score is calculated (range 6-24). This questionnaire will be completed daily at 1 pm.
Time frame: 7 days
Ecological Momentary Assessment
In the smartphone application, subject will be prompted four times a day with the following statements. The EMA assessment will occur daily at 9.00 am, 1.00 pm, 5.00 pm, 9.00 pm. Subjects are asked to indicate their current state on a VAS (Visual analog Scale). The score in the scale ranges from 0 to 100. 0 being "Not at all" and 100 being "Very Much". The participants will be asked to respond to the following questions: "Right now, I feel mentally sharp" - to assess perception of cognitive ability "Right now, I feel fatigued" - to assess fatigue/exhaustion directly "Right now, I feel stressed" - to assess stress "Right now, I feel nervous" - to assess nervousness/tension "Right now, I feel depressed" - to assess depression "Right now, I am in a good mood" - to assess joy "Right now, I feel thirsty" - to assess level of thirst "Right now, I feel hungry" - to assess level of hunger "I slept well last night" - to assess subjective sleep quality
Time frame: 7 days
Activity
Activity level, including #steps, distance traveled, and floors climbed, is measured using a Fitbit Sense 2 smart watch.
Time frame: 7 days
Respiratory rate
Respiratory rate (breaths per minute) is measured using a Fitbit Sense 2 smart watch.
Time frame: 7 days
Heart rate
Heart rate (beats per minute) is continuously measured using a Fitbit Sense 2 smart watch.
Time frame: 7 days
Sleep
Sleep duration (minutes) and quality are measured using a Fitbit Sense 2 smart watch.
Time frame: 7 days
Blood oxygenation level (SpO2)
Blood oxygenation level (%) is measured using a Fitbit Sense 2 smart watch.
Time frame: 7 days
Electrodermal activity (EDA)
In four user-initiated 2-min sessions per day, Electrodermal activity is measured via a Fitbit Sense 2 smart watch.
Time frame: 7 days
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