Trial | NCT02758990  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    cocoa bean coffee spinach broccoli ...

  • Study Participants

    16
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.
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 Started
Mar 31
2016
Primary Completion
Nov 23
2016
Study Completion
Nov 23
2016
Last Update
Oct 02
2017

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 names: Pyridoxine

Dietary Supplement Vitamin C

Subjects will be asked to increase vitamin C intake by 500 mg per day.

  • Other names: Ascorbic acid

Dietary Supplement Nicotinamide

Subjects will be asked to increase Nicotinamide intake by 500 mg per day.

  • Other names: Niacinamide

Dietary Supplement Vitamin D3

Subjects will be asked to increase Vitamin D3 intake by 1000 International Units per day.

  • Other names: Cholecalciferol

Dietary Supplement Vitamin E

Subjects will be asked to increase vitamin E intake by 400 International Units per day.

  • Other names: α-tocopherol

Other Broccoli

Subjects will be asked to increase broccoli intake by 8 fluid ounces (~91 grams) per day.

  • Other names: Brassica oleracea

Other Spinach

Subjects will be asked to increase spinach intake by 8 fluid ounces (~30 grams) per day.

  • Other names: Spinacia oleracea

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

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.

Predictions: BMI vs. Broccoli Experimental

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.

Predictions: BMI vs. Caffeine Experimental

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.

Predictions: BMI vs. Coffee Experimental

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.

Predictions: BMI vs. Spinach Experimental

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.

Predictions: BMI vs. Vitamin A Experimental

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.

Predictions: BMI vs. Vitamin C Experimental

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.

Predictions: Headache vs. Vitamin B6 Experimental

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.

Predictions: Headache vs. Vitamin C Experimental

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.

Predictions: Headache vs. Nicotinamide Experimental

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.

Predictions: Headache vs. Axon Eyewear Experimental

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.

Predictions: Rhinitis vs Broccoli Experimental

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.

Predictions: Rhinitis vs Caffeine Experimental

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.

Predictions: Rhinitis vs Chocolate Experimental

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.

Predictions: Rhinitis vs Coffee Experimental

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.

Predictions: Rhinitis vs Vitamin A Experimental

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.

Predictions: Insomnia vs Axon Eyewear Experimental

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.

Predictions: Insomnia vs Vitamin A Experimental

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.

Predictions: Insomnia vs Vitamin E Experimental

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.

Predictions: Insomnia vs Nicotinamide Experimental

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.

Predictions: Insomnia vs Vitamin D3 Experimental

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.

Predictions: Joint pain vs Broccoli Experimental

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.

Predictions: Joint pain vs Caffeine Experimental

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.

Predictions: Joint pain vs Coffee Experimental

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.

Predictions: Joint pain vs Spinach Experimental

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.

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
No Results Posted