Viome Precision Nutritional Programs to Improve Clinical Outcomes for Mental Health Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-75
SponsorViome
About this trial
US residents who have mental health issues sign the informed consent form and are screened and enrolled for this study. Participants complete a survey upon enrollment and are randomized into one of two study arms. This study is direct to participant and will NOT utilize clinical sites.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Resident of the United States
Females and males ages 25-75 (inclusive)
Able to speak and read English
No unexplained weight loss, fevers, anemia, or blood in stool
Disqualifiers
Unwilling to change their current diet
Prior use of Viome products or services
Antibiotic use in the previous 4 weeks
Pregnancy (current or planned in the next 4 months)
Trial design
Design model
Parallel
Treatments tested in this trial
VIOME Precision Nutrition Program
Combination productPrecision supplement based on the participants microbiome sample results. Participants in this arm may have any combination of supplements, diet recommendations, and/or coaching.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: PlaceboNo intervention 0 interventions
Group B: Viome's Precision Nutrition Program (VPNP)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Reduced PHQ-9 Score
Reduced PHQ-9 score for the VPNP group compared to baseline scores.
Time frame
~4 months2
Reduced GAD-7 Score
Reduced GAD-7 score for the VPNP groups compared to baseline scores.
Time frame
~4 months3
Reduced Perceived Stress Scale Score
Reduced Perceived Stress Scale score for the VPNP group compared to baseline scores.
Time frame
~4 months4
Increased Quality of Life Score
Increased quality of life score for the VPNP group compared to baseline scores.
Time frame
~4 months Source ClinicalTrials.gov