Nutritional Programs for Gastrointestinal Health

Overseen By Momchilo Vuyisich, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Viome

Must not be taking: Antibiotics, Investigational drugs

Disqualifiers: Pregnancy, IBD, Cancer therapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

150 Participants Needed

Trial Summary

What is the purpose of this trial?

US residents who have gastrointestinal issues 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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are prescribed drugs that may interact with the study supplements.

What data supports the effectiveness of the treatment VIOME-designed condition-based supplements and Viome Precision Nutrition Program for gastrointestinal health?

Research suggests that personalized nutrition advice, like that offered by Viome, can improve dietary intake more effectively than general advice, which may help manage conditions like inflammatory bowel disease by addressing individual dietary needs and reducing gut inflammation. ^{1 2 3 4 5}

Is the Viome Precision Nutrition Program safe for humans?

The available research does not provide specific safety data for the Viome Precision Nutrition Program or similar treatments, but it highlights the potential of personalized nutrition to improve health outcomes. However, more research is needed to confirm safety and effectiveness. ^{1 2 6 7 8}

How is the VIOME Precision Nutrition Program different from other treatments for gastrointestinal health?

The VIOME Precision Nutrition Program is unique because it offers personalized nutrition recommendations based on an individual's unique gut microbiome and health data, aiming to optimize health by tailoring dietary strategies to prevent and manage disease. This approach contrasts with standard treatments that often provide generalized dietary advice without considering individual genetic and microbiome differences. ^{1 2 4 8 9}

Research Team

Momchilo Vuyisich

Principal Investigator

Viome

Eligibility Criteria

This trial is for US residents aged 25-75 with gastrointestinal issues, specifically IBS as per ROME IV criteria and an IBS-SSS score of 125-450. Participants must understand English and be willing to follow the study's instructions after signing a consent form. Those with unexplained weight loss, fevers, anemia, or blood in stool cannot join.

Inclusion Criteria

Able to speak and read English

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

Exclusion Criteria

I currently have an infection.

Significant diet or lifestyle changes in the previous 1 month

I am not willing to change my current diet.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into one of three arms and receive either placebo, Viome's condition-based supplements, or Viome's Precision Nutrition Program for gastrointestinal wellness

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• VIOME-designed condition-based supplements
• VIOME Precision Nutrition Program

Trial Overview The Viome Nutritional Programs are being tested to see if they improve gastrointestinal health. Participants will complete a survey and then be randomly placed into one of three groups without visiting clinical sites. They'll either receive the VIOME Precision Nutrition Program or condition-based supplements designed by VIOME.

Participant Groups

Group I: Viome's condition-based supplements Active Control 1 Intervention

Participants who have gastrointestinal issues 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.

Group II: Placebo Active Control 1 Intervention

Participants who have gastrointestinal issues 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.

Group III: Viome's Precision Nutrition Program Active Control 1 Intervention

Participants who have gastrointestinal issues 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.

Who Is Running the Clinical Trial?

Viome

Lead Sponsor

Trials

22

Recruited

37,600+

Findings from Research

Current nutritional recommendations lack sufficient data for both group-level and individualized dietary guidance, highlighting a significant gap in the field.

Emerging technologies like genomics, proteomics, and metabolomics hold the potential to revolutionize personalized nutrition, but they are not yet widely utilized in practice, necessitating better education and interdisciplinary collaboration among nutritionists and scientists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized nutritional recommendations: do we have the measurements needed to assess risk and make dietary recommendations? Arab, L.[2008]

Diet plays a significant role in managing inflammatory bowel diseases (IBD), and personalized dietary strategies may help improve symptoms and nutritional status for individual patients.

The review emphasizes the need for tailored nutritional advice based on the unique clinical and molecular characteristics of IBD, suggesting that personalized approaches could lead to better management of inflammation and overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized Dietary Regimens for Inflammatory Bowel Disease: Current Knowledge and Future Perspectives. Wellens, J., Vissers, E., Matthys, C., et al.[2023]

The US Dietary Guidelines for Americans (DGA) have been in place for 40 years, yet many essential nutrients are still under-consumed, indicating a need for updated recommendations based on current evidence.

The paper suggests modernizing Dietary Reference Intakes (DRIs) for vitamins and minerals, particularly for vitamin K and magnesium, and establishing new DRIs for compounds like lutein and omega-3 fatty acids (EPA + DHA) to better support health and prevent deficiencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond Nutrient Deficiency-Opportunities to Improve Nutritional Status and Promote Health Modernizing DRIs and Supplementation Recommendations. McBurney, MI., Blumberg, JB., Costello, RB., et al.[2023]

Personalized nutrition (PN) is defined as a field that uses individual differences to create nutrition strategies aimed at preventing and managing diseases while optimizing health, emphasizing the need for a clear consensus to enhance research and clinical practice.

The field of PN can be divided into three key areas: science and data, education and training, and guidance and therapeutics, which together help healthcare professionals tailor nutrition interventions to individual needs and improve health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward the Definition of Personalized Nutrition: A Proposal by The American Nutrition Association. Bush, CL., Blumberg, JB., El-Sohemy, A., et al.[2021]

Personalized nutrition (PN) interventions lead to greater improvements in dietary intake compared to generalized dietary advice, based on a systematic review of 11 randomized controlled trials involving 57 to 1488 participants across the US, Canada, and Europe.

The studies showed a low risk of bias and varied follow-up durations from 1 to 12 months, indicating that tailored dietary advice can be more effective, but further research is needed to explore different personalization methods and incorporate behavior-change techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Personalized Nutrition Advice Improve Dietary Intake in Healthy Adults? A Systematic Review of Randomized Controlled Trials. Jinnette, R., Narita, A., Manning, B., et al.[2023]

A survey of 452 adults in Germany revealed that about 45% are open to genetic testing for personalized nutrition advice, indicating a strong interest in tailored dietary recommendations based on individual health risks.

Over 40% of participants expressed a willingness to purchase functional food products designed to reduce cardiovascular disease risk, suggesting a promising market for personalized nutrition solutions, although challenges in implementation remain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumer demand for personalized nutrition and functional food. Roosen, J., Bruhn, M., Mecking, RA., et al.[2022]

Precision nutrition research highlights that individual responses to diets can vary significantly due to interactions between dietary factors and personal genetic makeups, which has implications for health outcomes like obesity and weight loss.

Emerging studies suggest that a comprehensive multiomics approach, including factors like the gut microbiome and biological rhythms, could enhance the prediction of how individuals respond to different diets, paving the way for personalized dietary recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition for precision health: The time is now. Qi, L.[2022]

The gut microbiota plays a crucial role in human health, influencing the balance between gut bacteria, nutrients, and the body's genetic and physiological factors, which can affect disease outcomes.

The concept of the 'gutome' highlights the importance of understanding host-microbiome interactions and how nutrigenomics can lead to significant advancements in biomedicine and public health policy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The human gutome: nutrigenomics of the host-microbiome interactions. Dimitrov, DV.[2011]

The BASIC language program effectively assesses nutritional status using anthropometric, immunological, and clinical data, allowing for a comprehensive evaluation of individual health.

This program not only streamlines the process of diagnosing nutritional issues but also aids in creating personalized diets, enhancing both accuracy and efficiency in nutritional management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A computer program for assessing nutritional status and diet preparation]. Rodríguez, MC., Rodríguez-Mariscal, MJ., Martínez, JA., et al.[2013]

References

1. England pubmed.ncbi.nlm.nih.gov

Individualized nutritional recommendations: do we have the measurements needed to assess risk and make dietary recommendations? [2008]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Personalized Dietary Regimens for Inflammatory Bowel Disease: Current Knowledge and Future Perspectives. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Beyond Nutrient Deficiency-Opportunities to Improve Nutritional Status and Promote Health Modernizing DRIs and Supplementation Recommendations. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Toward the Definition of Personalized Nutrition: A Proposal by The American Nutrition Association. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Does Personalized Nutrition Advice Improve Dietary Intake in Healthy Adults? A Systematic Review of Randomized Controlled Trials. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Consumer demand for personalized nutrition and functional food. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Nutrition for precision health: The time is now. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The human gutome: nutrigenomics of the host-microbiome interactions. [2011]

9. Spain pubmed.ncbi.nlm.nih.gov

[A computer program for assessing nutritional status and diet preparation]. [2013]