Interventional Testing of Gene-environment Interactions Via the Verifomics Mobile Application
NCT ID: NCT02758990
Last Updated: 2017-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
16 participants
INTERVENTIONAL
2016-03-31
2016-11-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Predictions: BMI vs. Broccoli
BMI will be calculated from self-reported weight (once per day) and height (at enrollment). Each gene-environment interaction of interest will be evaluated to determine its predictive power.
Broccoli
Subjects will be asked to increase broccoli intake by 8 fluid ounces (\~91 grams) per day.
Predictions: BMI vs. Caffeine
BMI will be calculated from self-reported weight (once per day) and height (at enrollment). Each gene-environment interaction of interest will be evaluated to determine its predictive power.
Caffeine
Subjects will be asked to increase caffeine intake by taking 200mg caffeine orally once per day.
Predictions: BMI vs. Coffee
BMI will be calculated from self-reported weight (once per day) and height (at enrollment). Each gene-environment interaction of interest will be evaluated to determine its predictive power.
Coffee
Subjects will be asked to increase coffee intake by drinking 2 cups (177 mL each) of coffee per day.
Predictions: BMI vs. Spinach
BMI will be calculated from self-reported weight (once per day) and height (at enrollment). Each gene-environment interaction of interest will be evaluated to determine its predictive power.
Spinach
Subjects will be asked to increase spinach intake by 8 fluid ounces (\~30 grams) per day.
Predictions: BMI vs. Vitamin A
BMI will be calculated from self-reported weight (once per day) and height (at enrollment). Each gene-environment interaction of interest will be evaluated to determine its predictive power.
Vitamin A
Subjects will be asked to increase vitamin A intake by 8000 International Units per day.
Predictions: BMI vs. Vitamin C
BMI will be calculated from self-reported weight (once per day) and height (at enrollment). Each gene-environment interaction of interest will be evaluated to determine its predictive power.
Vitamin C
Subjects will be asked to increase vitamin C intake by 500 mg per day.
Predictions: Headache vs. Vitamin B6
Headache frequency and severity will be evaluated via a graphical and written pain scale, reported once per day. Each gene-environment interaction of interest will be evaluated to determine its predictive power.
Vitamin B6
Subjects will be asked to increase vitamin B6 intake by 50 mg per day.
Predictions: Headache vs. Vitamin C
Headache frequency and severity will be evaluated via a graphical and written pain scale, reported once per day. Each gene-environment interaction of interest will be evaluated to determine its predictive power.
Vitamin C
Subjects will be asked to increase vitamin C intake by 500 mg per day.
Predictions: Headache vs. Nicotinamide
Headache frequency and severity will be evaluated via a graphical and written pain scale, reported once per day. Each gene-environment interaction of interest will be evaluated to determine its predictive power.
Nicotinamide
Subjects will be asked to increase Nicotinamide intake by 500 mg per day.
Predictions: Headache vs. Axon Eyewear
Headache frequency and severity will be evaluated via a graphical and written pain scale, reported once per day. Each gene-environment interaction of interest will be evaluated to determine its predictive power.
Axon Eyewear
Subjects will be asked to utilize the therapeutic eyewear when exposed to bright or fluorescent light.
Predictions: Rhinitis vs Broccoli
Rhinitis frequency and severity will be self-reported on a scale from 0 to 10, with 0 indicating no rhinitis, 3 indicating minor rhinitis, 6 indicating rhinitis while preserving the ability to breathe nasally, and 10 indicating rhinitis to such a degree that mouth-breathing is required, reported once per day. Each gene-environment interaction of interest will be evaluated to determine its predictive power.
Broccoli
Subjects will be asked to increase broccoli intake by 8 fluid ounces (\~91 grams) per day.
Predictions: Rhinitis vs Caffeine
Rhinitis frequency and severity will be self-reported on a scale from 0 to 10, with 0 indicating no rhinitis, 3 indicating minor rhinitis, 6 indicating rhinitis while preserving the ability to breathe nasally, and 10 indicating rhinitis to such a degree that mouth-breathing is required, reported once per day. Each gene-environment interaction of interest will be evaluated to determine its predictive power.
Caffeine
Subjects will be asked to increase caffeine intake by taking 200mg caffeine orally once per day.
Predictions: Rhinitis vs Chocolate
Rhinitis frequency and severity will be self-reported on a scale from 0 to 10, with 0 indicating no rhinitis, 3 indicating minor rhinitis, 6 indicating rhinitis while preserving the ability to breathe nasally, and 10 indicating rhinitis to such a degree that mouth-breathing is required, reported once per day. Each gene-environment interaction of interest will be evaluated to determine its predictive power.
Chocolate
Subjects will be asked to increase chocolate intake by eating 57g per day.
Predictions: Rhinitis vs Coffee
Rhinitis frequency and severity will be self-reported on a scale from 0 to 10, with 0 indicating no rhinitis, 3 indicating minor rhinitis, 6 indicating rhinitis while preserving the ability to breathe nasally, and 10 indicating rhinitis to such a degree that mouth-breathing is required, reported once per day. Each gene-environment interaction of interest will be evaluated to determine its predictive power.
Coffee
Subjects will be asked to increase coffee intake by drinking 2 cups (177 mL each) of coffee per day.
Predictions: Rhinitis vs Vitamin A
Rhinitis frequency and severity will be self-reported on a scale from 0 to 10, with 0 indicating no rhinitis, 3 indicating minor rhinitis, 6 indicating rhinitis while preserving the ability to breathe nasally, and 10 indicating rhinitis to such a degree that mouth-breathing is required, reported once per day. Each gene-environment interaction of interest will be evaluated to determine its predictive power.
Vitamin A
Subjects will be asked to increase vitamin A intake by 8000 International Units per day.
Predictions: Insomnia vs Axon Eyewear
Sleep quality will be self-reported about the previous night's sleep on a scale from 0 to 10, with 0 indicating sleep that was not restful at all, 3 indicating mildly restful but insufficient sleep, 6 indicating a functional quality of sleep but not ideal, and 10 indicating ideal sleep, reported once per day. Each gene-environment interaction of interest will be evaluated to determine its predictive power.
Axon Eyewear
Subjects will be asked to utilize the therapeutic eyewear when exposed to bright or fluorescent light.
Predictions: Insomnia vs Vitamin A
Sleep quality will be self-reported about the previous night's sleep on a scale from 0 to 10, with 0 indicating sleep that was not restful at all, 3 indicating mildly restful but insufficient sleep, 6 indicating a functional quality of sleep but not ideal, and 10 indicating ideal sleep, reported once per day. Each gene-environment interaction of interest will be evaluated to determine its predictive power.
Vitamin A
Subjects will be asked to increase vitamin A intake by 8000 International Units per day.
Predictions: Insomnia vs Vitamin E
Sleep quality will be self-reported about the previous night's sleep on a scale from 0 to 10, with 0 indicating sleep that was not restful at all, 3 indicating mildly restful but insufficient sleep, 6 indicating a functional quality of sleep but not ideal, and 10 indicating ideal sleep, reported once per day. Each gene-environment interaction of interest will be evaluated to determine its predictive power.
Vitamin E
Subjects will be asked to increase vitamin E intake by 400 International Units per day.
Predictions: Insomnia vs Nicotinamide
Sleep quality will be self-reported about the previous night's sleep on a scale from 0 to 10, with 0 indicating sleep that was not restful at all, 3 indicating mildly restful but insufficient sleep, 6 indicating a functional quality of sleep but not ideal, and 10 indicating ideal sleep, reported once per day. Each gene-environment interaction of interest will be evaluated to determine its predictive power.
Nicotinamide
Subjects will be asked to increase Nicotinamide intake by 500 mg per day.
Predictions: Insomnia vs Vitamin D3
Sleep quality will be self-reported about the previous night's sleep on a scale from 0 to 10, with 0 indicating sleep that was not restful at all, 3 indicating mildly restful but insufficient sleep, 6 indicating a functional quality of sleep but not ideal, and 10 indicating ideal sleep, reported once per day. Each gene-environment interaction of interest will be evaluated to determine its predictive power.
Vitamin D3
Subjects will be asked to increase Vitamin D3 intake by 1000 International Units per day.
Predictions: Joint pain vs Broccoli
Joint pain frequency and severity will be evaluated via a graphical and written pain scale, reported once per day. Each gene-environment interaction of interest will be evaluated to determine its predictive power.
Broccoli
Subjects will be asked to increase broccoli intake by 8 fluid ounces (\~91 grams) per day.
Predictions: Joint pain vs Caffeine
Joint pain frequency and severity will be evaluated via a graphical and written pain scale, reported once per day. Each gene-environment interaction of interest will be evaluated to determine its predictive power.
Caffeine
Subjects will be asked to increase caffeine intake by taking 200mg caffeine orally once per day.
Predictions: Joint pain vs Coffee
Joint pain frequency and severity will be evaluated via a graphical and written pain scale, reported once per day. Each gene-environment interaction of interest will be evaluated to determine its predictive power.
Coffee
Subjects will be asked to increase coffee intake by drinking 2 cups (177 mL each) of coffee per day.
Predictions: Joint pain vs Spinach
Joint pain frequency and severity will be evaluated via a graphical and written pain scale, reported once per day. Each gene-environment interaction of interest will be evaluated to determine its predictive power.
Spinach
Subjects will be asked to increase spinach intake by 8 fluid ounces (\~30 grams) per day.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vitamin A
Subjects will be asked to increase vitamin A intake by 8000 International Units per day.
Vitamin B6
Subjects will be asked to increase vitamin B6 intake by 50 mg per day.
Vitamin C
Subjects will be asked to increase vitamin C intake by 500 mg per day.
Nicotinamide
Subjects will be asked to increase Nicotinamide intake by 500 mg per day.
Vitamin D3
Subjects will be asked to increase Vitamin D3 intake by 1000 International Units per day.
Vitamin E
Subjects will be asked to increase vitamin E intake by 400 International Units per day.
Broccoli
Subjects will be asked to increase broccoli intake by 8 fluid ounces (\~91 grams) per day.
Spinach
Subjects will be asked to increase spinach intake by 8 fluid ounces (\~30 grams) per day.
Caffeine
Subjects will be asked to increase caffeine intake by taking 200mg caffeine orally once per day.
Coffee
Subjects will be asked to increase coffee intake by drinking 2 cups (177 mL each) of coffee per day.
Axon Eyewear
Subjects will be asked to utilize the therapeutic eyewear when exposed to bright or fluorescent light.
Chocolate
Subjects will be asked to increase chocolate intake by eating 57g per day.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Immediately life-threatening disease
* Current use of nutritional supplements of interest (excluded from those interventions to prevent overdose)
* For spinach interventions, gout
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Verifomics LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Brody Holohan, PhD
Role: PRINCIPAL_INVESTIGATOR
Verifomics LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Verifomics, LLC
Dallas, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Website that begins the remote enrollment and participation process. Advertising material present on the site has been approved by the institutional review board.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
001
Identifier Type: -
Identifier Source: org_study_id