Clinical trial NCT02758990: Interventional Testing of Gene-environment Interactions Via the Verifomics Mobile Application
Official title: Interventional Testing of Gene-environment Interactions Via the Verifomics Mobile Application
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Rhinitis
Rhinitis, Allergic
Respiratory Sounds
Dyspnea
Headache
Migraine Disorders
Arthritis
Arthralgia
Anxiety
Sleep Initiation and Maintenance Disorders
Sleep Deprivation
Keywords: Food
Nutrigenomics
Precision Medicine
Pharmacogenetics
Lifestyle
Lead sponsor: Verifomics LLC
Sponsor class: INDUSTRY
First posted: 2016-05-03
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Frequency of correct predictions
timeFrame: Assessed 30 days after enrollment, comparing values of phenotypes of interest in the final week of the intervention to the value at enrollment and determining if the actual response is consistent with the prediction made prior to enrollment
Secondary outcomes:
measure: Genotype-independent effects of substances of interest
timeFrame: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
measure: Change in body mass index
timeFrame: Assessed 30 days after enrollment, comparing value at enrollment to value after 30 days of participation
measure: Change in headache severity
timeFrame: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
measure: Change in headache frequency
timeFrame: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
measure: Change in rhinitis severity
timeFrame: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
measure: Change in rhinitis frequency
timeFrame: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
measure: Change in insomnia frequency
timeFrame: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
measure: Change in insomnia severity
timeFrame: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
measure: Change in joint pain severity
timeFrame: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
measure: Change in joint pain frequency
timeFrame: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
measure: "Question of the day" questionnaire
timeFrame: Daily for the duration of participation (2 to 6 months), starting on the day of enrollment and ending when the intervention is concluded, either because the scientific endpoints are met or the subjects voluntarily halt participation..
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Verifomics, LLC
state: Texas
Study officials:
affiliation: Verifomics LLC
name: Brody Holohan, PhD
role: PRINCIPAL_INVESTIGATOR
References: