Nutritional programs to improve metabolic health
Testing the Efficacy of Viome-designed Condition-based Supplements and Viome Precision Supplements to Improve Clinical Outcomes for Metabolic Conditions
NA · Viome · NCT05564273
This study is testing if a special diet and supplements can help people with obesity improve their metabolic health over four months.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 25 Years to 75 Years |
| Sex | All |
| Sponsor | Viome (industry) |
| Locations | 1 site (Bothell, Washington) |
| Trial ID | NCT05564273 on ClinicalTrials.gov |
What this trial studies
This study involves U.S. residents with obesity who are randomized into three groups: a placebo group, a group receiving Viome's condition-based supplements, and a group following the Viome Precision Nutrition Program. Participants will complete a survey upon enrollment and will receive dietary recommendations and/or supplements aimed at improving metabolic wellness over a period of approximately four months. The study is designed to assess the effectiveness of these interventions in managing metabolic conditions without utilizing traditional clinical sites.
Who should consider this trial
Good fit: Ideal candidates for this study are U.S. residents aged 25-75 with obesity and elevated fasting insulin or glucose levels.
Not a fit: Patients who are unwilling to change their current diet or have recently made significant lifestyle changes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide personalized nutritional strategies to improve metabolic health in individuals with obesity.
How similar studies have performed: While there have been studies on dietary interventions for metabolic health, this specific approach using Viome's personalized nutrition programs is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bothell, Washington
- Viome Life Sciences — Bothell, Washington, United States (RECRUITING)
Study contacts
- Principal investigator: Momchilo Vuyisich — Viome Life Sciences
- Study coordinator: Mory Mehrtash
- Email: studies@viome.com
- Phone: (425) 300-6933
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Metabolic Health, BMI, Framingham Risk Score, Insulin, blood glucose, HbA1c, hsCRP, Lipids