Feeling Anxious, Sleep Disturbance, Stress
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERActive Gut Feeling Product 1
Participants will use their Active Gut Feeling Product 1 as directed for a period of 12 weeks
OTHERActive Gut Feeling Product 2
Participants will use their Active Gut Feeling Product 2 as directed for a period of 12 weeks
OTHERPlacebo Gut Feeling Control Product
Participants will use their Placebo Gut Feeling Control Product as directed for a period of 12 weeks
Sponsors
Holobiome, Inc.
Radicle Science
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received.
Intervention model description
Participants who complete enrollment will first be stratified to ensure balanced distribution across study arms. Stratification is based on sex at birth (female, non-female), age (21-39, 40-59, ≥60 years), wearable sub-study enrollment (yes/no), continuous glucose monitor (CGM) interest (yes/no), and PROMIS™ Anxiety 8A T-score category (mild: 55.0-59.9, moderate-low: 60.0-64.9, moderate-high: 65.0-69.9). Study product formulation is not included as a stratification factor. Within each stratum, participants are sequentially randomized to either an active study product arm or the shared placebo arm. Randomization uses equal probability of assignment to any active arm while maintaining the prespecified placebo-to-active allocation ratios based on Dunnett's optimal allocation for the number of active treatment arms.
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
Criteria: 3.1 Inclusion Participants must meet all of the following criteria: * Adults aged 21-80 years (inclusive) at the time of electronic informed consent, of any ethnicity, race, or gender identity * Assigned sex at birth determines sex-specific PRO branching (e.g., menstrual interference) where applicable * Reside in the contiguous 48 states in the United States and is able to provide a valid US shipping address and and 10-digit mobile phone number * Per state regulations, individuals residing in New York, New Jersey, and Rhode Island will be excluded * Capable of providing voluntary, electronic informed consent and willing to comply with study procedures, including remote biospecimen collection * PROMIS Anxiety 8A T-score between 55.0 and 69.9 (inclusive) at screening, corresponding to mild-to-moderate anxiety symptoms. * On a stable medication regimen for ≥30 days prior to screening and willing to maintain that regimen for the duration of the trial, unless changes are deemed medically necessary by the participant's healthcare provider. Stable, prescribed psychotropic medications (including SSRIs, SNRIs, and other antidepressants or anxiolytics) are not exclusionary. * Willing to take a study product and not know the intervention arm assignment (active or placebo) or the product identity. * Reliable daily access to the internet via mobile device or computer 3.2 Exclusion Individuals who report any of the following during screening may be excluded from participation: * Currently pregnant, planning to become pregnant during the trial, or breastfeeding * Unable to read and understand English at a 7th-grade reading level * Currently enrolled in another interventional clinical trial or planning to enroll in one during the trial timeline * Heavy alcohol consumption (defined for female sex assigned at birth \>/= 2 alcoholic beverages/day, male sex assigned at birth \>/=3/day) or use of recreational or illicit drugs other than cannabis * History of bariatric or weight-loss surgery (e.g., Roux-en-Y gastric bypass, sleeve gastrectomy, adjustable gastric banding, or biliopancreatic diversion). * Reports a current diagnosis of inflammatory bowel disease (ulcerative colitis or Crohn's disease). * Current or recent (within 3 months) major illness, surgery, or hospitalization posing a known significant safety risk * Diagnosis of cardiac dysfunction, severe liver disease, or severe kidney disease that presents a known contraindication to study product ingredients or substantial safety risk: * NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure * Significant immunocompromise, including diagnosed primary or acquired immunodeficiency, current chemotherapy, current immunotherapy, current use of immunosuppressive medications, or daily corticosteroid dose \>5 mg prednisone-equivalent * Antibiotic use (oral, IV) currently or within 30 days prior to screening * Plans to start a new structured dietary regimen (including new probiotic or prebiotic supplementation outside the study product) during the trial period * Use of medications with a well-established interaction posing a substantial safety risk with study product ingredients * Active suicidality as determined by a response of 3 in item 9 of the PHQ-9 score at screening * Known hypersensitivity to any component of the study products * Wave-specific
Exclusion criteria
per Subprotocol A (Wave 1) or Subprotocol B (Wave 2) Note on medication exclusions: routine prescription medications (including antihypertensives, anticoagulants at standard outpatient doses, antiseizure medications, and medications carrying a grapefruit-consumption warning) are not categorically excluded. Specific medications posing a documented safety risk in combination with the food ingredients (products) are addressed by the study screening Q-bank. * Participants residing in the states of New York, New Jersey, or Rhode Island are not eligible to participate in the study. This restriction is due to state regulatory requirements governing direct-to-consumer at-home laboratory specimen collection and processing that cannot be accommodated within the fully decentralized design of the study. No alternative collection pathway is available under the current protocol. * To ensure compliance, state-of-residence logic is built into the enrollment platform. Participants who indicate a residential address in New York, New Jersey, or Rhode Island will not be eligible. This automated screening ensures that ineligible participants are not inadvertently enrolled in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in feelings of anxiety | 18 weeks | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in sleep | 18 weeks | 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) |
| Change in severity of generalized anxiety | 18 weeks | 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) |
| Change in the severity of depression | 18 weeks | 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) |
| Change in recovery from stress and adversity | 18 weeks | 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) |
| Change in measure of self-perceived success | 18 weeks | 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) |
| Change in depression, anxiety, and stress | 18 weeks | 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) |
Countries
United States
Contacts
CONTACTStudy Manager
CONTACTSusan Hewlings
Outcome results
None listed