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

Primary Purpose

Obesity, Rhinitis, Rhinitis, Allergic

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin A
Vitamin B6
Vitamin C
Nicotinamide
Vitamin D3
Vitamin E
Broccoli
Spinach
Caffeine
Coffee
Axon Eyewear
Chocolate
Sponsored by
Verifomics LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Food, Nutrigenomics, Precision Medicine, Pharmacogenetics, Lifestyle

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Verifomics, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm 19

Arm 20

Arm 21

Arm 22

Arm 23

Arm 24

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Predictions: BMI vs. Broccoli

Predictions: BMI vs. Caffeine

Predictions: BMI vs. Coffee

Predictions: BMI vs. Spinach

Predictions: BMI vs. Vitamin A

Predictions: BMI vs. Vitamin C

Predictions: Headache vs. Vitamin B6

Predictions: Headache vs. Vitamin C

Predictions: Headache vs. Nicotinamide

Predictions: Headache vs. Axon Eyewear

Predictions: Rhinitis vs Broccoli

Predictions: Rhinitis vs Caffeine

Predictions: Rhinitis vs Chocolate

Predictions: Rhinitis vs Coffee

Predictions: Rhinitis vs Vitamin A

Predictions: Insomnia vs Axon Eyewear

Predictions: Insomnia vs Vitamin A

Predictions: Insomnia vs Vitamin E

Predictions: Insomnia vs Nicotinamide

Predictions: Insomnia vs Vitamin D3

Predictions: Joint pain vs Broccoli

Predictions: Joint pain vs Caffeine

Predictions: Joint pain vs Coffee

Predictions: Joint pain vs Spinach

Arm Description

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Frequency of correct predictions
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

Genotype-independent effects of substances of interest
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
Change in headache severity
Change in headache frequency
Change in rhinitis severity
Change in rhinitis frequency
Change in insomnia frequency
Change in insomnia severity
Change in joint pain severity
Change in joint pain frequency
"Question of the day" questionnaire
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.

Full Information

First Posted
April 26, 2016
Last Updated
September 27, 2017
Sponsor
Verifomics LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02758990
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
Recruiting and financial constraints
Study Start Date
March 2016 (undefined)
Primary Completion Date
November 23, 2016 (Actual)
Study Completion Date
November 23, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Verifomics LLC

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Rhinitis, Rhinitis, Allergic, Respiratory Sounds, Dyspnea, Headache, Migraine Disorders, Arthritis, Arthralgia, Anxiety, Sleep Initiation and Maintenance Disorders, Sleep Deprivation
Keywords
Food, Nutrigenomics, Precision Medicine, Pharmacogenetics, Lifestyle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Predictions: BMI vs. Broccoli
Arm Type
Experimental
Arm Description
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.
Arm Title
Predictions: BMI vs. Caffeine
Arm Type
Experimental
Arm Description
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.
Arm Title
Predictions: BMI vs. Coffee
Arm Type
Experimental
Arm Description
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.
Arm Title
Predictions: BMI vs. Spinach
Arm Type
Experimental
Arm Description
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.
Arm Title
Predictions: BMI vs. Vitamin A
Arm Type
Experimental
Arm Description
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.
Arm Title
Predictions: BMI vs. Vitamin C
Arm Type
Experimental
Arm Description
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.
Arm Title
Predictions: Headache vs. Vitamin B6
Arm Type
Experimental
Arm Description
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.
Arm Title
Predictions: Headache vs. Vitamin C
Arm Type
Experimental
Arm Description
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.
Arm Title
Predictions: Headache vs. Nicotinamide
Arm Type
Experimental
Arm Description
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.
Arm Title
Predictions: Headache vs. Axon Eyewear
Arm Type
Experimental
Arm Description
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.
Arm Title
Predictions: Rhinitis vs Broccoli
Arm Type
Experimental
Arm Description
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.
Arm Title
Predictions: Rhinitis vs Caffeine
Arm Type
Experimental
Arm Description
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.
Arm Title
Predictions: Rhinitis vs Chocolate
Arm Type
Experimental
Arm Description
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.
Arm Title
Predictions: Rhinitis vs Coffee
Arm Type
Experimental
Arm Description
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.
Arm Title
Predictions: Rhinitis vs Vitamin A
Arm Type
Experimental
Arm Description
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.
Arm Title
Predictions: Insomnia vs Axon Eyewear
Arm Type
Experimental
Arm Description
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.
Arm Title
Predictions: Insomnia vs Vitamin A
Arm Type
Experimental
Arm Description
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.
Arm Title
Predictions: Insomnia vs Vitamin E
Arm Type
Experimental
Arm Description
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.
Arm Title
Predictions: Insomnia vs Nicotinamide
Arm Type
Experimental
Arm Description
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.
Arm Title
Predictions: Insomnia vs Vitamin D3
Arm Type
Experimental
Arm Description
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.
Arm Title
Predictions: Joint pain vs Broccoli
Arm Type
Experimental
Arm Description
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.
Arm Title
Predictions: Joint pain vs Caffeine
Arm Type
Experimental
Arm Description
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.
Arm Title
Predictions: Joint pain vs Coffee
Arm Type
Experimental
Arm Description
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.
Arm Title
Predictions: Joint pain vs Spinach
Arm Type
Experimental
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
Vitamin A
Other Intervention Name(s)
Retinol, Retinoic acid
Intervention Description
Subjects will be asked to increase vitamin A intake by 8000 International Units per day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin B6
Other Intervention Name(s)
Pyridoxine
Intervention Description
Subjects will be asked to increase vitamin B6 intake by 50 mg per day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin C
Other Intervention Name(s)
Ascorbic acid
Intervention Description
Subjects will be asked to increase vitamin C intake by 500 mg per day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nicotinamide
Other Intervention Name(s)
Niacinamide
Intervention Description
Subjects will be asked to increase Nicotinamide intake by 500 mg per day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
Cholecalciferol
Intervention Description
Subjects will be asked to increase Vitamin D3 intake by 1000 International Units per day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin E
Other Intervention Name(s)
α-tocopherol
Intervention Description
Subjects will be asked to increase vitamin E intake by 400 International Units per day.
Intervention Type
Other
Intervention Name(s)
Broccoli
Other Intervention Name(s)
Brassica oleracea
Intervention Description
Subjects will be asked to increase broccoli intake by 8 fluid ounces (~91 grams) per day.
Intervention Type
Other
Intervention Name(s)
Spinach
Other Intervention Name(s)
Spinacia oleracea
Intervention Description
Subjects will be asked to increase spinach intake by 8 fluid ounces (~30 grams) per day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Caffeine
Other Intervention Name(s)
1,3,7-Trimethylpurine-2,6-dione
Intervention Description
Subjects will be asked to increase caffeine intake by taking 200mg caffeine orally once per day.
Intervention Type
Other
Intervention Name(s)
Coffee
Intervention Description
Subjects will be asked to increase coffee intake by drinking 2 cups (177 mL each) of coffee per day.
Intervention Type
Device
Intervention Name(s)
Axon Eyewear
Intervention Description
Subjects will be asked to utilize the therapeutic eyewear when exposed to bright or fluorescent light.
Intervention Type
Other
Intervention Name(s)
Chocolate
Intervention Description
Subjects will be asked to increase chocolate intake by eating 57g per day.
Primary Outcome Measure Information:
Title
Frequency of correct predictions
Description
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.
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
Secondary Outcome Measure Information:
Title
Genotype-independent effects of substances of interest
Description
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.
Time Frame
Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Title
Change in body mass index
Time Frame
Assessed 30 days after enrollment, comparing value at enrollment to value after 30 days of participation
Title
Change in headache severity
Time Frame
Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Title
Change in headache frequency
Time Frame
Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Title
Change in rhinitis severity
Time Frame
Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Title
Change in rhinitis frequency
Time Frame
Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Title
Change in insomnia frequency
Time Frame
Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Title
Change in insomnia severity
Time Frame
Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Title
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
Title
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
Title
"Question of the day" questionnaire
Description
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.
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..

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brody Holohan, PhD
Organizational Affiliation
Verifomics LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Verifomics, LLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75219
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://verifomics.com/
Description
Website that begins the remote enrollment and participation process. Advertising material present on the site has been approved by the institutional review board.

Learn more about this trial

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

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