Viome Nutritional Programs to Improve Clinical Outcomes for Metabolic Conditions

NCT05564273 | Recruiting

• 1 other identifier: V211.2
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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 three arms. This study is direct to participant and will not utilize clinical sites.

Conditions

Metabolic Health

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Efficacy of VIOME's designed condition based supplements (VCS)

  Number of participants that show an improvement in metabolic health compared to baseline survey assessment.

  ~4months

• Efficacy of VIOME Precision Nutrition Program (VPNP)

  Number of participants that show an improvement in metabolic health compared to baseline survey assessment.

  ~4 months

Study Arms (3)

Placebo

NO 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.

Viome's Precision Nutrition Program

ACTIVE COMPARATOR

Participants may be provided with any combination of nutritional recommendations and supplements. The participants are asked to take the supplements on a daily basis.

Combination Product: VIOME Precision Nutrition Program

Viome's condition-based supplements

ACTIVE COMPARATOR

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.

Dietary Supplement: VIOME-designed condition-based supplements

Interventions

VIOME Precision Nutrition Program COMBINATION_PRODUCT

Precision supplement based on the participants microbiome sample results. Participants in this arm may receive supplements, diet recommendations, and app coaching.

Also known as: VPNP

Viome's Precision Nutrition Program

VIOME-designed condition-based supplements DIETARY_SUPPLEMENT

Pre-formulated supplements based on overall health conditions. Participants in this arm may receive supplements, diet recommendations, and app coaching.

Also known as: VCS

Viome's condition-based supplements

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Viome: lead

Study Sites (1)

Viome Life Sciences

Bothell, Washington, 98011, United States

RECRUITING

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Momchilo Vuyisich

  Viome Life Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mory Mehrtash

CONTACT

(425) 300-6933; studies@viome.com

Momchilo Vuyisich

CONTACT

(425) 300-6933; studies@viome.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Once enrolled, participants are randomized into one of the three arms. The coded supplements with blinded labels are shipped to the participants. The participants are not aware of which group they are randomized into.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, blinded, cohort study divided into three arms: 1) control group (placebo), 2) condition-based supplement, 3) precision-supplement

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 3, 2022
• Study Start: October 13, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)