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This is a randomized, placebo-controlled trial that will test the efficacy of VPNP in reducing HbA1c. Participant recruitment will occur through direct-to-participant enrollment. No additional clinical sites will be used for recruitment.
This is a randomized, placebo-controlled trial that will test the efficacy of VPNP in reducing HbA1c. Participants with HbA1c levels between 5.7-8.9% (inclusive) will be recruited and randomized into either the placebo or intervention group. The study duration for each participant will be approximately 90 days. At the beginning of the 90 days, the participant will complete online questionnaires, a blood draw, and a set of at-home sample collections for blood, stool, and saliva that will be sent back to Viome. After the samples are analyzed, the participant will receive dietary recommendations (either personalized or USDA) and supplements (either personalized or placebo). The participant will follow the dietary recommendations and take the supplements for 90 days. At the end of the 90 days, the participant will once again complete online questionnaires, a blood draw, and a set of at-home sample collections for blood, stool, and saliva that will be sent back to Viome for analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | No Intervention | Participants with HbA1c levels between 5.7-8.9% (inclusive) are randomized into this arm. They may be provided with any combination of nutritional recommendations and supplements. Placebo capsules will contain inert and inactive materials. Participants may need to use a mobile app in order to participate in the trial. | |
| Viome's Precision Nutrition Program (VPNP) | Experimental | Participants with HbA1c levels between 5.7-8.9% (inclusive) are randomized into this arm. They may be provided with any combination of nutritional recommendations and supplements. Participants may need to use a mobile app in order to participate in the trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Viome's Precision Nutrition Program (VPNP) | Dietary Supplement | Nutrition, diet, and possible coaching through Viome application. Precision supplement based on the participants microbiome sample results. |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c Levels | HbA1c changes in individuals in the interventional arm compared to baseline measurement. | 4 months |
| Insulin Resistance | Change in fasting insulin levels in those in the interventional arm compared to baseline measurement. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| BMI | Changes in BMI of individuals in the interventional arm compared to baseline measurement. | 4 months |
| Cholesterol | Changes in HDL, LDL, total cholesterol, and triglyceride levels of those in the interventional arm compared to baseline measurements. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mory Mehrtash | Contact | (425) 300-6933 | studies@viome.com | |
| Momchilo Vuyisich | Contact | (425) 300-6933 | studies@viome.com |
| Name | Affiliation | Role |
|---|---|---|
| Momchilo Vuyisich | Viome | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Viome Life Sciences | Recruiting | Bothell | Washington | 98011 | United States |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Participants will be blinded for this study.
| 4 months |
| Waist to Hip Ratio | Changes in waist to hip ratio of those in the interventional group compared to baseline measurement. | 4 months |
| Cardiovascular Risk | Changes to 10 year cardiovascular risk score of those in the interventional arm compared to baseline score. | 4 months |
| Patient Health Questionnaire 9 (PHQ 9) Score | Changes in PHQ9 score of those in the interventional arm compared to baseline answers. The minimum PHQ 9 score is 0 and the maximum PHQ 9 score is 27. Higher scores indicate a worse outcome. | 4 months |
| General Anxiety Disorder - 7 Score | Changes in GAD7 score in those in the interventional arm compared to baseline assessment. The minimum score on GAD 7 is 0-4 indicating none to minimal anxiety and the maximum score is 15-21 indicating sever anxiety. Higher scores indicate a worse outcome. | 4 months |
| Species prevalence in stool, blood, and saliva | Changes in the prevalence of species in stool, blood, and saliva samples compared to baseline analysis. | 4 months |
| Fasting glucose | Fasting glucose changes in individuals in the interventional arm compared to baseline measurement. | 4 months |
| D006943 | Hyperglycemia |