NCT02758990

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Verifomics LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin A	Subjects will be asked to increase vitamin A intake by 8000 International Units per day.
DIETARY_SUPPLEMENT	Vitamin B6	Subjects will be asked to increase vitamin B6 intake by 50 mg per day.
DIETARY_SUPPLEMENT	Vitamin C	Subjects will be asked to increase vitamin C intake by 500 mg per day.
DIETARY_SUPPLEMENT	Nicotinamide	Subjects will be asked to increase Nicotinamide intake by 500 mg per day.
DIETARY_SUPPLEMENT	Vitamin D3	Subjects will be asked to increase Vitamin D3 intake by 1000 International Units per day.
DIETARY_SUPPLEMENT	Vitamin E	Subjects will be asked to increase vitamin E intake by 400 International Units per day.
OTHER	Broccoli	Subjects will be asked to increase broccoli intake by 8 fluid ounces (\~91 grams) per day.
OTHER	Spinach	Subjects will be asked to increase spinach intake by 8 fluid ounces (\~30 grams) per day.
DIETARY_SUPPLEMENT	Caffeine	Subjects will be asked to increase caffeine intake by taking 200mg caffeine orally once per day.
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.

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-11-23
• Completion: 2016-11-23
• First posted: 2016-05-03
• Last updated: 2017-10-02

Locations

1 site across 1 country: United States