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

• ClinicalTrials.gov Identifier: NCT02758990
• Recruitment Status: Terminated
• First Posted: May 3, 2016
• Last Update Posted: October 2, 2017
• Sponsor: Verifomics LLC
• Information provided by (Responsible Party): Verifomics LLC

Tracking Information

• First Submitted Date: April 26, 2016
• First Posted Date: May 3, 2016
• Last Update Posted Date: October 2, 2017
• Study Start Date: March 2016
• Actual Primary Completion Date: November 23, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 2, 2016)

Frequency of correct predictions [ Time Frame: Assessed 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 2, 2016)

• Genotype-independent effects of substances of interest [ Time Frame: Assessed 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 body mass index [ Time Frame: Assessed 30 days after enrollment, comparing value at enrollment to value after 30 days of participation ]
• Change in headache severity [ Time Frame: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation ]
• Change in headache frequency [ Time Frame: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation ]
• Change in rhinitis severity [ Time Frame: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation ]
• Change in rhinitis frequency [ Time Frame: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation ]
• Change in insomnia frequency [ Time Frame: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation ]
• Change in insomnia severity [ Time Frame: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation ]
• Change in joint pain severity [ Time Frame: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation ]
• Change in joint pain frequency [ Time Frame: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation ]
• "Question of the day" questionnaire [ Time Frame: Daily 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Interventional Testing of Gene-environment Interactions Via the Verifomics Mobile Application
• Official Title: Interventional Testing of Gene-environment Interactions Via the Verifomics Mobile Application
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Obesity
• Rhinitis
• Rhinitis, Allergic
• Respiratory Sounds
• Dyspnea
• Headache
• Migraine Disorders
• Arthritis
• Arthralgia
• Anxiety
• Sleep Initiation and Maintenance Disorders
• Sleep Deprivation

Intervention

• Dietary Supplement: Vitamin A
  Subjects will be asked to increase vitamin A intake by 8000 International Units per day.
  Other Names:

  • Retinol
  • Retinoic acid
• Dietary Supplement: Vitamin B6
  Subjects will be asked to increase vitamin B6 intake by 50 mg per day.
  Other Name: Pyridoxine
• Dietary Supplement: Vitamin C
  Subjects will be asked to increase vitamin C intake by 500 mg per day.
  Other Name: Ascorbic acid
• Dietary Supplement: Nicotinamide
  Subjects will be asked to increase Nicotinamide intake by 500 mg per day.
  Other Name: Niacinamide
• Dietary Supplement: Vitamin D3
  Subjects will be asked to increase Vitamin D3 intake by 1000 International Units per day.
  Other Name: Cholecalciferol
• Dietary Supplement: Vitamin E
  Subjects will be asked to increase vitamin E intake by 400 International Units per day.
  Other Name: α-tocopherol
• Other: Broccoli
  Subjects will be asked to increase broccoli intake by 8 fluid ounces (~91 grams) per day.
  Other Name: Brassica oleracea
• Other: Spinach
  Subjects will be asked to increase spinach intake by 8 fluid ounces (~30 grams) per day.
  Other Name: Spinacia oleracea
• Dietary Supplement: Caffeine
  Subjects will be asked to increase caffeine intake by taking 200mg caffeine orally once per day.
  Other Name: 1,3,7-Trimethylpurine-2,6-dione
• Other: Coffee
  Subjects will be asked to increase coffee intake by drinking 2 cups (177 mL each) of coffee per day.
• Device: Axon Eyewear
  Subjects will be asked to utilize the therapeutic eyewear when exposed to bright or fluorescent light.
• Other: Chocolate
  Subjects will be asked to increase chocolate intake by eating 57g per day.

Study Arms

• Experimental: 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.
  Intervention: Other: Broccoli
• Experimental: 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.
  Intervention: Dietary Supplement: Caffeine
• Experimental: 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.
  Intervention: Other: Coffee
• Experimental: 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.
  Intervention: Other: Spinach
• Experimental: 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.
  Intervention: Dietary Supplement: Vitamin A
• Experimental: 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.
  Intervention: Dietary Supplement: Vitamin C
• Experimental: 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.
  Intervention: Dietary Supplement: Vitamin B6
• Experimental: 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.
  Intervention: Dietary Supplement: Vitamin C
• Experimental: 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.
  Intervention: Dietary Supplement: Nicotinamide
• Experimental: 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.
  Intervention: Device: Axon Eyewear
• Experimental: 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.
  Intervention: Other: Broccoli
• Experimental: 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.
  Intervention: Dietary Supplement: Caffeine
• Experimental: 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.
  Intervention: Other: Chocolate
• Experimental: 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.
  Intervention: Other: Coffee
• Experimental: 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.
  Intervention: Dietary Supplement: Vitamin A
• Experimental: 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.
  Intervention: Device: Axon Eyewear
• Experimental: 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.
  Intervention: Dietary Supplement: Vitamin A
• Experimental: 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.
  Intervention: Dietary Supplement: Vitamin E
• Experimental: 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.
  Intervention: Dietary Supplement: Nicotinamide
• Experimental: 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.
  Intervention: Dietary Supplement: Vitamin D3
• Experimental: 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.
  Intervention: Other: Broccoli
• Experimental: 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.
  Intervention: Dietary Supplement: Caffeine
• Experimental: 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.
  Intervention: Other: Coffee
• Experimental: 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.
  Intervention: Other: Spinach

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: September 27, 2017): 16
• Original Estimated Enrollment (submitted: May 2, 2016): 500
• Actual Study Completion Date: November 23, 2016
• Actual Primary Completion Date: November 23, 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02758990
• Other Study ID Numbers: 001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Verifomics LLC
• Original Responsible Party: Same as current
• Current Study Sponsor: Verifomics LLC
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Brody Holohan, PhD; Verifomics LLC

• PRS Account: Verifomics LLC
• Verification Date: October 2016