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Precision Nutrition Program
Viome Nutritional Programs for Metabolic Health
N/A
Recruiting
Led By Momchilo Vuyisich
Research Sponsored by Viome
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ~4months
Awards & highlights
Study Summary
This trial will test three different treatments for metabolic issues in US residents. Participants will be randomly assigned to one of the three groups, and will be surveyed at the beginning and end of the trial. The trial will not be conducted at clinical sites.
Who is the study for?
This trial is for US residents aged 25-75 with obesity, defined as a BMI of 30+ and waist-to-hip ratio over 1. Participants must be able to follow instructions, speak English, and use Viome's App on a smartphone. Exclusions include GERD sufferers, recent mothers or pregnant women, those with certain medical conditions like IBD or liver disease, and anyone on specific diets or medications that could interfere.Check my eligibility
What is being tested?
The study tests the VIOME Precision Nutrition Program and condition-based supplements designed by VIOME. It involves completing surveys and being randomly assigned to one of three groups without clinical site visits. The aim is to see if these interventions can improve metabolic health in obese individuals.See study design
What are the potential side effects?
Potential side effects are not specified but may include reactions to supplement ingredients if allergies exist. Participants should not have any known medical conditions that might interact with the supplements.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ ~4months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~~4months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy of VIOME Precision Nutrition Program (VPNP)
Efficacy of VIOME's designed condition based supplements (VCS)
Trial Design
3Treatment groups
Active Control
Group I: Viome's Precision Nutrition ProgramActive Control1 Intervention
Participants may be provided with any combination of nutritional recommendations and supplements. The participants are asked to take the supplements on a daily basis.
Group II: Viome's condition-based supplementsActive Control1 Intervention
Participants may be provided with any combination of nutritional recommendations and they receive condition based supplements. The participants are asked to take the supplements on a daily basis.
Group III: PlaceboActive Control1 Intervention
Participants may be provided with any combination of nutritional recommendations and they receive placebo supplements. Placebo capsules will contain inert and inactive materials. The participants are asked to take the supplements on a daily basis.
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Who is running the clinical trial?
ViomeLead Sponsor
19 Previous Clinical Trials
17,387 Total Patients Enrolled
Momchilo VuyisichPrincipal InvestigatorViome Life Sciences
11 Previous Clinical Trials
2,612 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not willing to visit Quest for tests.I have not had cancer treatment in the last year.I am taking medication that could interact with the trial's supplements.I haven't had unexplained weight loss, fevers, anemia, or blood in my stool.I am not pregnant, planning to become pregnant, or breastfeeding.I cannot or do not want to use Viome's App on a smartphone.I haven't used any experimental drugs or devices in the last month.I have been diagnosed with inflammatory bowel disease (IBD).I am currently using or have used insulin injections.I haven't had major surgery in the last 6 months and don't plan any in the next 4 months.I am between 25 and 75 years old.I am not willing to change my current diet.I am taking (or have taken) medication that increases insulin.I have not taken antibiotics in the last 4 weeks.I have used Viome products or services before.I currently have an infection.I do not have any health conditions or allergies that would prevent me from safely taking the supplements.
Research Study Groups:
This trial has the following groups:- Group 1: Viome's Precision Nutrition Program
- Group 2: Viome's condition-based supplements
- Group 3: Placebo
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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