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| Name | Class |
|---|---|
| OBVIO HEALTH USA, Inc. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Stress | No Intervention | Reference Group | |
| Elevated Stress | No Intervention | Half of the Participants(n=40) with elevated stress (PSS score >13) will be randomly assigned to this group | |
| Elevated Stress intervention | Experimental | Half of the Participants(n=40) with High stress (PSS score >13) will be randomly assigned to this group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional supplement | Dietary Supplement | Nutritional intervention hypothesized to have an acute anxiolytic effect |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Stool microbiome composition | Stool samples will be collected at home on the first test day and analyzed for gut microbiome composition using shotgun metagenomic sequencing. | baseline |
| stool microbiome functional potential |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore Institute for Clinical Trials | Singapore | 117609 | Singapore |
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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8-day parallel-group design with decentralized data collection
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| 7 days |
| Activity | Activity level, including #steps, distance traveled, and floors climbed, is measured using a Fitbit Sense 2 smart watch. | 7 days |
| Respiratory rate | Respiratory rate (breaths per minute) is measured using a Fitbit Sense 2 smart watch. | 7 days |
| Heart rate | Heart rate (beats per minute) is continuously measured using a Fitbit Sense 2 smart watch. | 7 days |
| Sleep | Sleep duration (minutes) and quality are measured using a Fitbit Sense 2 smart watch. | 7 days |
| Blood oxygenation level (SpO2) | Blood oxygenation level (%) is measured using a Fitbit Sense 2 smart watch. | 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. | 7 days |
In addition to mapping the taxonomic abundance, the gut microbiome functional potential will be analysed using Biobakery analysis tools.
| baseline |