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

Obesity Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT02758990
• Study type: Interventional
• Source: Verifomics LLC
• Status: Terminated
• Phase: N/A
• Start date: March 2016
• Completion date: November 23, 2016