NCT05564273 · Viome
Viome Nutritional Programs to Improve Clinical Outcomes for Metabolic Conditions
What this study is about
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 randomly assigned into one of three treatment group$1. This study is direct to participant and will not utilize clinical sites.
View original scientific description
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 three arms. This study is direct to participant and will not utilize clinical sites.
Interventions
COMBINATION_PRODUCT
VIOME Precision Nutrition Program
Precision supplement based on the participants microbiome sample results. Participants in this arm may receive supplements, diet recommendations, and app coaching.
DIETARY_SUPPLEMENT
VIOME-designed condition-based supplements
Pre-formulated supplements based on overall health conditions. Participants in this arm may receive supplements, diet recommendations, and app coaching.
Primary outcome measures
Efficacy of VIOME's designed condition based supplements (VCS)
Time frame: ~4months
Number of participants that show an improvement in metabolic health compared to baseline survey assessment.
Efficacy of VIOME Precision Nutrition Program (VPNP)
Time frame: ~4 months
Number of participants that show an improvement in metabolic health compared to baseline survey assessment.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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.
- Fasting insulin level \>=15 uIU/mL or fasting glucose \>= 100 mg/dL within the last 3 months, verified from medical records
Exclusion criteria
- Unwilling to change current diet
- Unwilling to go to Quest
- Prior use of Viome products or services
- Antibiotic use in the previous 4 weeks
- Women who are pregnant (current or planned in the next 4 months), or breastfeeding
- \< 90 days postpartum
- Active infection
- Unable or unwilling to use Viome's App on an iPhone or Android smartphone
- Significant diet or lifestyle changes in the previous 1 month
- IBD diagnosis
- 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
- Current (or previous) use of medications that increase insulin (sulfonylureas, such as glimepiride, glipizide, glyburide, etc.)
- Current (or previous) use of exogenous insulin (such as Tresiba, Lantus, Toujeo, Levemir, Humalog, Novolog, Apidra, Fiasp, etc.)
- Prescribed any drug(s) that may interact with the supplement formulations
- Have any medical condition or allergy that may interact with, or prevents the healthy consumption of the supplements such as: Pregnancy Breastfeeding Minors GERD Gastric Ulcers Ulcerative Colitis Crohn's Disease Kidney Impairment (kidney cysts, kidney disease) Liver Condition (gallstones, cholecystitis, cirrhosis, hepatitis, hepatitis a, hepatitis b, hepatitis c, NAFLD/NASH, etc) HIV SIBO CuminAllergy GymnemaAllergy BacopaAllergy CitrusAIlergy LamiaceaeAllergy SageAllergy YeastAllergy MulberryAllergy ChicoryAllergy
- Allergies to any study-specific supplement ingredients
- Currently on a specific diet: FODMAP KETO PALEO
- 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
Where
- Bothell, Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 29, 2025 · Source of record for eligibility and locations