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Interventional Testing of Gene-environment Interactions Via the Verifomics Mobile Application

Not Applicable
Terminated
Conditions
Arthralgia
Sleep Deprivation
Respiratory Sounds
Obesity
Rhinitis, Allergic
Migraine Disorders
Anxiety
Sleep Initiation and Maintenance Disorders
Rhinitis
Dyspnea
Registration Number
NCT02758990
Lead Sponsor
Verifomics LLC
Brief Summary

The purpose of this study is to study interactions between genes, lifestyle environmental factors like foods, nutritional supplements and non-invasive medical devices and health factors that can be measured without specialized medical equipment in order to develop lifestyle recommendations tailored to individual genetics for a host of common chronic health conditions.

Detailed Description

The study is composed of multiple interventions which will last between 2 and 6 months that evaluate a suite of predictions about the way that a given environmental factor impacts a specific health outcome based on genetic information obtained from direct-to-consumer genotyping providers (AncestryDNA and 23andMe). Substances of interest include foods, nutritional supplements and non-invasive medical devices.

A minimum of 500 subjects will be enrolled in each intervention, and only those subjects which are predicted to benefit from the intervention when considering all sites of interest will be assigned to an intervention. The predictions are based on hundreds to thousands of sites of interest at high minor allele frequency single nucleotide polymorphisms and predictions about response are derived from the aggregate genotype at all loci considered. As such each site of interest will have a built-in negative control group composed of individuals enrolled in the intervention despite a genotype at that site that does not predict a benefit. The rate that each site of interest makes correct predictions about subject response will be compared to randomly-selected sites in order to quantify placebo effects and establish quality metrics for the predictions.

Enrollment and participation are conducted remotely. Participants will upload genetic information from a direct-to-consumer provider through a mobile or web browser application, and informed consent and inclusion/exclusion criteria are accomplished remotely. After the informed consent process, participants are asked what phenotype of interest (weight, migraines, insomnia, etc.) they are interested in studying, their genetic information is evaluated and they are allowed to select an intervention they qualify for based on their genetics that they would like to participate in. Participants then answer a series of questions to establish baseline data on relevant factors as well as evaluate the inclusion and exclusion criteria; participants that qualify for the intervention are then given specific instructions on how to participate, and may then use the software to report data during the intervention. Each intervention utilizes a specific product rather than a general class of product to reduce noise from differing sourcing, distribution, storage and manufacturing practices.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
16
Inclusion Criteria
  • For BMI interventions, BMI > 25
  • For headache interventions, more than 2 headache-days per month
  • For insomnia interventions, at least one day of self-reported poor sleep per week
  • For rhinitis interventions, more than 2 days with symptoms per month
  • For joint pain interventions, at least one day of self-reported joint pain per week
Exclusion Criteria
  • Women who are pregnant, nursing or attempting to become pregnant
  • Immediately life-threatening disease
  • Current use of nutritional supplements of interest (excluded from those interventions to prevent overdose)
  • For spinach interventions, gout

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Frequency of correct predictionsAssessed 30 days after enrollment, comparing values of phenotypes of interest in the final week of the intervention to the value at enrollment and determining if the actual response is consistent with the prediction made prior to enrollment

Each site of interest is being evaluated for its ability to make correct predictions about subject response. This frequency will be compared via a variety of statistical techniques to that expected by chance to establish its clinical utility.

Secondary Outcome Measures
NameTimeMethod
Change in joint pain frequencyAssessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Genotype-independent effects of substances of interestAssessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation

Baseline responses to environmental factors studied in terms of phenotypes of interest are measured to remove this potential bias from the analysis of predictive power.

Change in rhinitis frequencyAssessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Change in body mass indexAssessed 30 days after enrollment, comparing value at enrollment to value after 30 days of participation
Change in headache severityAssessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Change in headache frequencyAssessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Change in rhinitis severityAssessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Change in insomnia frequencyAssessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Change in insomnia severityAssessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Change in joint pain severityAssessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
"Question of the day" questionnaireDaily for the duration of participation (2 to 6 months), starting on the day of enrollment and ending when the intervention is concluded, either because the scientific endpoints are met or the subjects voluntarily halt participation..

Asynchronous longitudinal observations about subject health, diet, environment, lifestyle and anecdotal observations to be used to guide future studies, control for co-linear changes in behavior, monitor for serendipitous events and assess environment-environment interactions. Subjects are asked to answer one question from the survey per day, and questions are asked recurrently at question-specific intervals.

Trial Locations

Locations (1)

Verifomics, LLC

🇺🇸

Dallas, Texas, United States

Verifomics, LLC
🇺🇸Dallas, Texas, United States

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