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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02758990
• Other study ID #: 001
• Status: Terminated
• Phase: N/A
• First received: April 26, 2016
• Last updated: September 27, 2017
• Start date: March 2016
• Est. completion date: November 23, 2016

Study information

• Verified date: October 2016
• Source: Verifomics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: November 23, 2016
• Est. primary completion date: November 23, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Intervention

Dietary Supplement:
• Vitamin A
Subjects will be asked to increase vitamin A intake by 8000 International Units per day.
• Vitamin B6
Subjects will be asked to increase vitamin B6 intake by 50 mg per day.
• Vitamin C
Subjects will be asked to increase vitamin C intake by 500 mg per day.
• Nicotinamide
Subjects will be asked to increase Nicotinamide intake by 500 mg per day.
• Vitamin D3
Subjects will be asked to increase Vitamin D3 intake by 1000 International Units per day.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Verifomics, LLC	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Verifomics LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of correct predictions	Each site of interest is being evaluated for its ability to make correct predictions about subject response. This frequency will be compared via a variety of statistical techniques to that expected by chance to establish its clinical utility.	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	Genotype-independent effects of substances of interest	Baseline responses to environmental factors studied in terms of phenotypes of interest are measured to remove this potential bias from the analysis of predictive power.	Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Secondary	Change in body mass index		Assessed 30 days after enrollment, comparing value at enrollment to value after 30 days of participation
Secondary	Change in headache severity		Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Secondary	Change in headache frequency		Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Secondary	Change in rhinitis severity		Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Secondary	Change in rhinitis frequency		Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Secondary	Change in insomnia frequency		Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Secondary	Change in insomnia severity		Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Secondary	Change in joint pain severity		Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Secondary	Change in joint pain frequency		Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Secondary	"Question of the day" questionnaire	Asynchronous longitudinal observations about subject health, diet, environment, lifestyle and anecdotal observations to be used to guide future studies, control for co-linear changes in behavior, monitor for serendipitous events and assess environment-environment interactions. Subjects are asked to answer one question from the survey per day, and questions are asked recurrently at question-specific intervals.	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..

External Links

•   Website that begins the remote enrollment and participation process. Advertising material present on the site has been approved by the institutional review board.