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

September 27, 2017 updated by: Verifomics LLC
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75219
        • Verifomics, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Broccoli
Subjects will be asked to increase broccoli intake by 8 fluid ounces (~91 grams) per day.
Other Names:
  • Brassica oleracea
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.
Dietary supplement: Caffeine
Subjects will be asked to increase caffeine intake by taking 200mg caffeine orally once per day.
Other Names:
  • 1,3,7-Trimethylpurine-2,6-dione
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.
Other: Coffee
Subjects will be asked to increase coffee intake by drinking 2 cups (177 mL each) of coffee per day.
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.
Other: Spinach
Subjects will be asked to increase spinach intake by 8 fluid ounces (~30 grams) per day.
Other Names:
  • Spinacia oleracea
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.
Dietary supplement: Vitamin A
Subjects will be asked to increase vitamin A intake by 8000 International Units per day.
Other Names:
  • Retinoic acid
  • Retinol
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.
Dietary supplement: Vitamin C
Subjects will be asked to increase vitamin C intake by 500 mg per day.
Other Names:
  • Ascorbic acid
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.
Dietary supplement: Vitamin B6
Subjects will be asked to increase vitamin B6 intake by 50 mg per day.
Other Names:
  • Pyridoxine
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.
Dietary supplement: Vitamin C
Subjects will be asked to increase vitamin C intake by 500 mg per day.
Other Names:
  • Ascorbic acid
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.
Dietary supplement: Nicotinamide
Subjects will be asked to increase Nicotinamide intake by 500 mg per day.
Other Names:
  • Niacinamide
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.
Device: Axon Eyewear
Subjects will be asked to utilize the therapeutic eyewear when exposed to bright or fluorescent light.
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.
Other: Broccoli
Subjects will be asked to increase broccoli intake by 8 fluid ounces (~91 grams) per day.
Other Names:
  • Brassica oleracea
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.
Dietary supplement: Caffeine
Subjects will be asked to increase caffeine intake by taking 200mg caffeine orally once per day.
Other Names:
  • 1,3,7-Trimethylpurine-2,6-dione
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.
Other: Chocolate
Subjects will be asked to increase chocolate intake by eating 57g per day.
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.
Other: Coffee
Subjects will be asked to increase coffee intake by drinking 2 cups (177 mL each) of coffee per day.
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.
Dietary supplement: Vitamin A
Subjects will be asked to increase vitamin A intake by 8000 International Units per day.
Other Names:
  • Retinoic acid
  • Retinol
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.
Device: Axon Eyewear
Subjects will be asked to utilize the therapeutic eyewear when exposed to bright or fluorescent light.
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.
Dietary supplement: Vitamin A
Subjects will be asked to increase vitamin A intake by 8000 International Units per day.
Other Names:
  • Retinoic acid
  • Retinol
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.
Dietary supplement: Vitamin E
Subjects will be asked to increase vitamin E intake by 400 International Units per day.
Other Names:
  • α-tocopherol
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.
Dietary supplement: Nicotinamide
Subjects will be asked to increase Nicotinamide intake by 500 mg per day.
Other Names:
  • Niacinamide
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.
Dietary supplement: Vitamin D3
Subjects will be asked to increase Vitamin D3 intake by 1000 International Units per day.
Other Names:
  • Cholecalciferol
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.
Other: Broccoli
Subjects will be asked to increase broccoli intake by 8 fluid ounces (~91 grams) per day.
Other Names:
  • Brassica oleracea
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.
Dietary supplement: Caffeine
Subjects will be asked to increase caffeine intake by taking 200mg caffeine orally once per day.
Other Names:
  • 1,3,7-Trimethylpurine-2,6-dione
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.
Other: Coffee
Subjects will be asked to increase coffee intake by drinking 2 cups (177 mL each) of coffee per day.
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.
Other: Spinach
Subjects will be asked to increase spinach intake by 8 fluid ounces (~30 grams) per day.
Other Names:
  • Spinacia oleracea

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Change in body mass index
Time Frame: Assessed 30 days after enrollment, comparing value at enrollment to value after 30 days of participation
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
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
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
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
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
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
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
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
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.
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..

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Verifomics LLC

Investigators

  • Principal Investigator: Brody Holohan, PhD, Verifomics LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

November 23, 2016

Study Completion (Actual)

November 23, 2016

Study Registration Dates

First Submitted

April 26, 2016

First Submitted That Met QC Criteria

May 2, 2016

First Posted (Estimate)

May 3, 2016

Study Record Updates

Last Update Posted (Actual)

October 2, 2017

Last Update Submitted That Met QC Criteria

September 27, 2017

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (NavyGHB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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