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

V

Verifomics

Status

Terminated

Conditions

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

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

16 participants in 24 patient groups

Predictions: BMI vs. Broccoli
Experimental group
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.
Treatment:
Other: Broccoli
Predictions: BMI vs. Caffeine
Experimental group
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.
Treatment:
Dietary Supplement: Caffeine
Predictions: BMI vs. Coffee
Experimental group
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.
Treatment:
Other: Coffee
Predictions: BMI vs. Spinach
Experimental group
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.
Treatment:
Other: Spinach
Predictions: BMI vs. Vitamin A
Experimental group
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.
Treatment:
Dietary Supplement: Vitamin A
Predictions: BMI vs. Vitamin C
Experimental group
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.
Treatment:
Dietary Supplement: Vitamin C
Predictions: Headache vs. Vitamin B6
Experimental group
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.
Treatment:
Dietary Supplement: Vitamin B6
Predictions: Headache vs. Vitamin C
Experimental group
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.
Treatment:
Dietary Supplement: Vitamin C
Predictions: Headache vs. Nicotinamide
Experimental group
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.
Treatment:
Dietary Supplement: Nicotinamide
Predictions: Headache vs. Axon Eyewear
Experimental group
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.
Treatment:
Device: Axon Eyewear
Predictions: Rhinitis vs Broccoli
Experimental group
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.
Treatment:
Other: Broccoli
Predictions: Rhinitis vs Caffeine
Experimental group
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.
Treatment:
Dietary Supplement: Caffeine
Predictions: Rhinitis vs Chocolate
Experimental group
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.
Treatment:
Other: Chocolate
Predictions: Rhinitis vs Coffee
Experimental group
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.
Treatment:
Other: Coffee
Predictions: Rhinitis vs Vitamin A
Experimental group
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.
Treatment:
Dietary Supplement: Vitamin A
Predictions: Insomnia vs Axon Eyewear
Experimental group
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.
Treatment:
Device: Axon Eyewear
Predictions: Insomnia vs Vitamin A
Experimental group
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.
Treatment:
Dietary Supplement: Vitamin A
Predictions: Insomnia vs Vitamin E
Experimental group
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.
Treatment:
Dietary Supplement: Vitamin E
Predictions: Insomnia vs Nicotinamide
Experimental group
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.
Treatment:
Dietary Supplement: Nicotinamide
Predictions: Insomnia vs Vitamin D3
Experimental group
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.
Treatment:
Dietary Supplement: Vitamin D3
Predictions: Joint pain vs Broccoli
Experimental group
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.
Treatment:
Other: Broccoli
Predictions: Joint pain vs Caffeine
Experimental group
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.
Treatment:
Dietary Supplement: Caffeine
Predictions: Joint pain vs Coffee
Experimental group
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.
Treatment:
Other: Coffee
Predictions: Joint pain vs Spinach
Experimental group
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.
Treatment:
Other: Spinach

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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