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

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

NCT02758990

001

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)

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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