The goal of this study is to evaluate the effects of different products in participants experiencing feelings of anxiety. The main question it aims to answer is: \- Do these products affect feelings of anxiety and related wellness outcomes compared with a placebo? Researchers will compare participants taking active products to those taking a placebo to see whether the active products influence feelings of anxiety and related outcomes, and to monitor safety. Participants will: * Be randomly assigned to receive either an active product or a placebo (an inactive look-alike). * Take their assigned product or placebo without knowing which group they are in until the study is completed. * Complete evaluations and tasks to track safety, feelings of anxiety, and related health outcomes.
This is a parallel group, randomized, double-blind, placebo-controlled study assessing the effects (if any) of different prebiotics (products) on self-reported feelings of anxiety and related health outcomes. The study is conducted in two sequential waves, each enrolling a similar population and evaluating distinct interventions, under a unified master protocol. Participants will not know their study arm assignment until the study is completed. The master protocol structure permits an efficient shared infrastructure for oversight, data management, safety monitoring, and biospecimen handling while maintaining scientific independence between the two waves. Each participant completes a 17-week study duration consisting of a 12-week double-blind intervention period (daily oral powder sachet consumed with food or beverage) followed by a 4-week washout period. This enables both within-arm time-course modeling and between-arm comparisons across intervention and post-intervention phases. Following electronic informed consent, identity verification via one-time passcode, and baseline health assessments, participants are stratified to ensure balanced distribution across arms. Within each stratum, participants are randomized to active or shared placebo arms and to compensation tiers that will enable the assessment of how (if) compensation affects study participation and compliance. To comprehensively track biological dynamics, the trial integrates multi-omic biospecimen collections and digital biomarker telemetry. Participants self-collect stool samples across four timepoints for deep metagenomic sequencing, untargeted fecal metabolomics, and to create a biobank. Finger-prick capillary blood samples are collected via microsampling devices for blood proteomic profiling at two time points. A consented sub-cohort applies an over-the-counter continuous glucose monitor for two weeks to evaluate glucose dynamics. Additional digital health streams include passive nightly wearable telemetry, weekly smartphone-based optical AI facial scans (Intelliprove) tracking physiological vitals, passive GPS-derived home-time proportion metrics, and weekly photographic food recall diaries.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
1,000
Participants will use their Active Gut Feeling Product 1 as directed for a period of 12 weeks
Participants will use their Active Gut Feeling Product 2 as directed for a period of 12 weeks
Participants will use their Placebo Gut Feeling Control Product as directed for a period of 12 weeks
Radicle Science Inc.
Del Mar, California, United States
Change in feelings of anxiety
Change in feelings of anxiety: Difference between rates of change over time in feelings of anxiety score as assessed by PROMIS Anxiety 8A (scale 8-40; with higher scores corresponding to more severe anxiety)
Time frame: 18 weeks
Change in sleep
Change in sleep: Difference in rates of change over time in sleep score as assessed by PROMIS Sleep Disturbance 8A (scale 8-40; where higher scores correspond to higher levels of sleep disturbance)
Time frame: 18 weeks
Change in severity of generalized anxiety
Change in severity of generalized anxiety: Difference between rates of change over time in feelings of generalized anxiety score as assessed by GAD-7 (scale 0-21; with higher scores corresponding to more severe anxiety)
Time frame: 18 weeks
Change in the severity of depression
Change in the severity of depression: Difference between rates of change over time in severity of depression as assessed by PHQ-9 (scale 0-27; with higher scores corresponding to more severe depression)
Time frame: 18 weeks
Change in recovery from stress and adversity
Change in recovery from stress and adversity: Difference between rates of change over time in recovery from stress and adversity as assessed by Brief Resilience Scale (scale 1-5; with higher scores corresponding to Higher Recovery)
Time frame: 18 weeks
Change in measure of self-perceived success
Change in measure of self-perceived success: Difference between rates of change over time in measure of self-perceived success as assessed by Flourishing Scale (scale 1-7; with higher scores corresponding to stronger sense of psychological prosperity and functioning)
Time frame: 18 weeks
Change in depression, anxiety, and stress
Change in Depression, Anxiety, and Stress: Difference between rates of change over time in depression, anxiety, and stress as assessed by DASS-8 (scale 1-4; with higher scores corresponding to Higher feelings of Depression, Anxiety, and Stress)
Time frame: 18 weeks
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