Mental Health IssueNCT06190184
Viome Precision Nutritional Programs to Improve Clinical Outcomes for Mental Health Conditions
A study testing VIOME Precision Nutrition Program in people with Mental Health Issue and Mental Health Disorder, run by Viome at 1 site in United States.
Trial summary
US residents who have obesity and sign the informed consent form and are screened and enrolled for this study. Participants who are enrolled complete a survey upon enrollment and are randomized into one of two arms. This study is direct to participant and will not utilize clinical sites. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Mental Health Issue, Mental Health Disorder, Mental Health
- What is being tested?
- VIOME Precision Nutrition Program
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Resident of the United States
- 50 years old and older OR BMI of 25 or greater
- Able to speak and read English
- No unexplained weight loss, fevers, anemia, or blood in stool
- Willing and able to follow the trial instructions, as described in the recruitment letter
- Signed and dated informed consent prior to any trial-specific procedures.
- PHQ9 score of 5-24 (inclusive)
Who cannot join
- 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)
- < 90 days postpartum
- Breast feeding
Show all 24Show fewer
- Active infection
- Unable or unwilling to use Viome's App on an iPhone or Android smartphone
- Significant diet or lifestyle change in the previous 1 month
- IBD diagnosis -Major psychiatric/DSM-4 disease diagnosis (e.g. Schizophrenia, Bipolar disorder, Post- traumatic Stress Disorder, Obsessive Compulsive disorder)
- Use of investigational drugs, products or devices within 1 month prior to and 4 months after the start of the trial
- Cancer therapy within the previous 1 year
- Major surgery in the last 6 months or planned in the next 4 months
- Allergies to any supplement ingredients listed in the screening survey
- Currently on a specific diet: FODMAP, KETO, PALEO
- Answered yes to the question, "In the past few weeks, have you wished you were dead or had thoughts about killing yourself?"
- Gastrointestinal disease including:
- GI surgery except:
- Appendectomy and benign polypectomy
- Esophagitis
- Celiac disease
- GI malignancy or obstruction
- Peptic Ulcer Disease
- Duodenal or gastric ulcer disease
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Viome Life Sciences
Bothell, Washington, 98011
Momchilo Vuyisich, PhD, 425-300-6933, studies@viome.com
Mory Mehrtash, MSHS, (425) 300-6933, studies@viome.com
About this study
Official title: Testing the Efficacy of Viome Precision Supplements to Improve Clinical Outcomes for Mental Health Conditions
US residents who have obesity and sign the informed consent form and are screened and enrolled for this study. Participants who are enrolled complete a survey upon enrollment and are randomized into one of two arms. This study is direct to participant and will not utilize clinical sites.
Read the detailed description
Participants who meet the eligibility criteria are randomized into any of the two arms including: the placebo arm or the VIOME Precision Nutrition Program (VPNP) arm.
Placebo and Viome's Precision Nutrition Program include supplements and/or dietary recommendations towards improving the symptoms associated with metabolic wellness. The trial will last approximately 4 months for each participant.
- Conditions
- Mental Health Issue, Mental Health Disorder, Mental Health, Depression, Depression, Anxiety, Anxiety
- Being tested
- VIOME Precision Nutrition Program, Control arm
- Keywords
- Mental Health, diet, supplements, vitamins, stress
- Medical subject headings
- Mental Disorders, Psychological Well-Being, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIOME Precision Nutrition ProgramCombination product
Also called VPNP
Precision supplement based on the participants microbiome sample results. Participants in this arm may have any combination of supplements, diet recommendations, and/or coaching.
Control armOther
Also called Placebo
Participants who have mental health issues are randomized into this arm. They may be provided with any combination of nutritional recommendations and/or supplements. Placebo capsules will contain inert and inactive materials. Participants may need to use a mobile app in order to participate in the trial.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants who have mental health issues are randomized into this study arm. They may be provided with any combination of nutritional recommendations and supplements. Placebo capsules will contain inert and inactive materials. Participants may need to use a mobile app in order to participate in the trial. Receives: Other: Control arm |
| Viome's Precision Nutrition Program (VPNP) | Experimental | Participants who have mental health issues are randomized into this study arm. They may be provided with any combination of nutritional recommendations and supplements. Participants may need to use a mobile app in order to participate in the trial. Receives: Combination Product: VIOME Precision Nutrition Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PHQ-9 Score
Change in PHQ-9 score for VPNP group compared to baseline scores.
Measured: 4 months
Change in GAD-7 Score
Change in GAD-7 score for VPNP group compared to baseline scores.
Measured: 4 months
Change in Quality of Life Score
Change in quality of life score for VPNP group compared to baseline scores.
Measured: 4 months
Change in Perceived Stress Scale Score
Change in perceived stress score for VPNP group compared to baseline scores.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start26 Oct 2023
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, blinded, cohort study divided into two study arms: 1) control group (placebo), 2) precision-supplement
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Viome
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Momchilo Vuyisich, Principal investigator, Viome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190184
- Sponsor's protocol ID
- V211.3.1
- Status last verified
- Jan 2024
- First submitted
- 8 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Efficacy of Viome Precision Supplements to Improve Clinical Outcomes for Mental Health Conditions
- ClinicalTrials.gov ID
- NCT06190184
- Acronym / sponsor ID
- V211.3.1
- Conditions
- Mental Health Issue, Mental Health Disorder, Mental Health, Depression, Depression, Anxiety, Anxiety
- Keywords
- Mental Health, diet, supplements, vitamins, stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ViomeIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
US residents who have obesity and sign the informed consent form and are screened and enrolled for this study. Participants who are enrolled complete a survey upon enrollment and are randomized into one of two arms. This study is direct to participant and will not utilize clinical sites.
Detailed description
Participants who meet the eligibility criteria are randomized into any of the two arms including: the placebo arm or the VIOME Precision Nutrition Program (VPNP) arm.
Placebo and Viome's Precision Nutrition Program include supplements and/or dietary recommendations towards improving the symptoms associated with metabolic wellness. The trial will last approximately 4 months for each participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, blinded, cohort study divided into two study arms: 1) control group (placebo), 2) precision-supplement
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Control armParticipants who have mental health issues are randomized into this study arm. They may be provided with any combination of nutritional recommendations and supplements. Placebo capsules will contain inert and inactive materials. Participants may need to use a mobile app in order to participate in the trial. |
| Viome's Precision Nutrition Program (VPNP) | Experimental | Combination Product: VIOME Precision Nutrition ProgramParticipants who have mental health issues are randomized into this study arm. They may be provided with any combination of nutritional recommendations and supplements. Participants may need to use a mobile app in order to participate in the trial. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Resident of the United States
- 50 years old and older OR BMI of 25 or greater
- Able to speak and read English
- No unexplained weight loss, fevers, anemia, or blood in stool
- Willing and able to follow the trial instructions, as described in the recruitment letter
Key exclusion criteria (24 listed)
- 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)
- < 90 days postpartum
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIOME Precision Nutrition ProgramAlso: VPNPPrecision supplement based on the participants microbiome sample results. Participants in this arm may have any combination of supplements, diet recommendations, and/or coaching. | Combination product | Viome's Precision Nutrition Program (VPNP) |
| Control armAlso: PlaceboParticipants who have mental health issues are randomized into this arm. They may be provided with any combination of nutritional recommendations and/or supplements. Placebo capsules will contain inert and inactive materials. Participants may need to use a mobile app in order to participate in the trial. | Other | Placebo |
Primary outcome
Change in PHQ-9 Score
Time frame: 4 months
Change in PHQ-9 score for VPNP group compared to baseline scores.
Change in GAD-7 Score
Time frame: 4 months
Change in GAD-7 score for VPNP group compared to baseline scores.
Change in Quality of Life Score
Time frame: 4 months
Change in quality of life score for VPNP group compared to baseline scores.
Change in Perceived Stress Scale Score
Time frame: 4 months
Change in perceived stress score for VPNP group compared to baseline scores.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Momchilo Vuyisich principal investigator
Viome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIOME Precision Nutrition Program in people with Mental Health Issue and Mental Health Disorder, run by Viome at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mory Mehrtash ((425) 300-6933, studies@viome.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PHQ-9 Score (time frame: 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.