RECRUITING

Viome Nutritional Programs to Improve Clinical Outcomes for Metabolic Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Testing the Efficacy of Viome-designed Condition-based Supplements and Viome Precision Supplements to Improve Clinical Outcomes for Metabolic Conditions

Quick Facts

Study Start:2023-10-13
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05564273

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Resident of the United States
  2. * Females and males ages 25-75 (inclusive)
  3. * Able to speak and read English
  4. * No unexplained weight loss, fevers, anemia, or blood in stool
  5. * Willing and able to follow the trial instructions, as described in the recruitment letter
  6. * Signed and dated informed consent prior to any trial-specific procedures.
  7. * Fasting insulin level \>=15 uIU/mL or fasting glucose \>= 100 mg/dL within the last 3 months, verified from medical records
  1. * Unwilling to change current diet
  2. * Unwilling to go to Quest
  3. * Prior use of Viome products or services
  4. * Antibiotic use in the previous 4 weeks
  5. * Women who are pregnant (current or planned in the next 4 months), or breastfeeding
  6. * \< 90 days postpartum
  7. * Active infection
  8. * Unable or unwilling to use Viome's App on an iPhone or Android smartphone
  9. * Significant diet or lifestyle changes in the previous 1 month
  10. * IBD diagnosis
  11. * Use of investigational drugs, products or devices within 1 month prior to and 4 months after the start of the trial
  12. * Cancer therapy within the previous 1 year
  13. * Major surgery in the last 6 months or planned in the next 4 months
  14. * Current (or previous) use of medications that increase insulin (sulfonylureas, such as glimepiride, glipizide, glyburide, etc.)
  15. * Current (or previous) use of exogenous insulin (such as Tresiba, Lantus, Toujeo, Levemir, Humalog, Novolog, Apidra, Fiasp, etc.)
  16. * Prescribed any drug(s) that may interact with the supplement formulations
  17. * Have any medical condition or allergy that may interact with, or prevents the healthy consumption of the supplements such as:
  18. * Allergies to any study-specific supplement ingredients
  19. * Currently on a specific diet:
  20. * Gastrointestinal disease including:
  21. * GI surgery except:
  22. * Appendectomy and benign polypectomy
  23. * Esophagitis
  24. * Celiac disease
  25. * GI malignancy or obstruction
  26. * Peptic Ulcer Disease
  27. * Duodenal or gastric ulcer disease

Contacts and Locations

Study Contact

Mory Mehrtash
CONTACT
(425) 300-6933
studies@viome.com
Momchilo Vuyisich
CONTACT
(425) 300-6933
studies@viome.com

Principal Investigator

Momchilo Vuyisich
PRINCIPAL_INVESTIGATOR
Viome Life Sciences

Study Locations (Sites)

Viome Life Sciences
Bothell, Washington, 98011
United States

Collaborators and Investigators

Sponsor: Viome

  • Momchilo Vuyisich, PRINCIPAL_INVESTIGATOR, Viome Life Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-13
Study Completion Date2024-12

Study Record Updates

Study Start Date2023-10-13
Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

  • BMI
  • Framingham Risk Score
  • Insulin
  • blood glucose
  • HbA1c
  • hsCRP
  • Lipids
  • Supplements
  • Vitamins
  • diet

Additional Relevant MeSH Terms

  • Metabolic Health