Viome Nutritional Programs to Improve Clinical Outcomes for Metabolic Conditions

Metabolic Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05564273
• Other study ID #: V211.2
• Status: Recruiting
• Phase: N/A
• Start date: October 13, 2023
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Viome
• Contact: Mory Mehrtash
• Phone: (425) 300-6933
• Email: studies[@]viome.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Participants who meet the eligibility criteria are randomized into any of the three arms including: the placebo arm, VIOME's condition-based supplements (VCS) arm or the VIOME Precision Nutrition Program (VPNP) arm.

Placebo, Viome-designed condition-based supplements and Viome's Precision Nutrition Program include supplements and/or dietary recommendations towards improving the symptoms associated with metabolic wellness. The trial will last approximately 4 months for each participant.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Health

Intervention

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.

Locations

Country	Name	City	State
United States	Viome Life Sciences	Bothell	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Viome

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Efficacy of VIOME Precision Nutrition Program (VPNP)	Number of participants that show an improvement in metabolic health compared to baseline survey assessment.	~4 months