We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02758990
Recruitment Status : Terminated (Recruiting and financial constraints)
First Posted : May 3, 2016
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Obesity Rhinitis Rhinitis, Allergic Respiratory Sounds Dyspnea Headache Migraine Disorders Arthritis Arthralgia Anxiety Sleep Initiation and Maintenance Disorders Sleep Deprivation Dietary Supplement: Vitamin A Dietary Supplement: Vitamin B6 Dietary Supplement: Vitamin C Dietary Supplement: Nicotinamide Dietary Supplement: Vitamin D3 Dietary Supplement: Vitamin E Other: Broccoli Other: Spinach Dietary Supplement: Caffeine Other: Coffee Device: Axon Eyewear Other: Chocolate

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interventional Testing of Gene-environment Interactions Via the Verifomics Mobile Application
Study Start Date : March 2016
Primary Completion Date : November 23, 2016
Study Completion Date : November 23, 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: 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 Name: 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:
  • Retinol
  • Retinoic acid
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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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:
  • Retinol
  • Retinoic acid
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:
  • Retinol
  • Retinoic acid
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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Spinacia oleracea


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Change in body mass index [ Time Frame: Assessed 30 days after enrollment, comparing value at enrollment to value after 30 days of participation ]
  3. Change in headache severity [ Time Frame: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation ]
  4. Change in headache frequency [ Time Frame: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation ]
  5. Change in rhinitis severity [ Time Frame: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation ]
  6. Change in rhinitis frequency [ Time Frame: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation ]
  7. Change in insomnia frequency [ Time Frame: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation ]
  8. Change in insomnia severity [ Time Frame: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation ]
  9. 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 ]
  10. 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 ]
  11. "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.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02758990


Locations
United States, Texas
Verifomics, LLC
Dallas, Texas, United States, 75219
Sponsors and Collaborators
Verifomics LLC
Investigators
Principal Investigator: Brody Holohan, PhD Verifomics LLC
More Information

Additional Information:
Responsible Party: Verifomics LLC
ClinicalTrials.gov Identifier: NCT02758990     History of Changes
Other Study ID Numbers: 001
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Verifomics LLC:
Food
Nutrigenomics
Precision Medicine
Pharmacogenetics
Lifestyle

Additional relevant MeSH terms:
Disease
Rhinitis
Headache
Dyspnea
Sleep Deprivation
Rhinitis, Allergic
Migraine Disorders
Sleep Initiation and Maintenance Disorders
Arthralgia
Respiratory Sounds
Pathologic Processes
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Respiration Disorders
Signs and Symptoms, Respiratory
Dyssomnias
Sleep Wake Disorders
Mental Disorders
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Headache Disorders, Primary
Headache Disorders