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

NCT02758990 | Terminated

• 1 other identifier: 001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Genotype-independent effects of substances of interest

  Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation

• Change in body mass index

  Assessed 30 days after enrollment, comparing value at enrollment to value after 30 days of participation

• Change in headache severity

  Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation

• Change in headache frequency

  Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation

• Change in rhinitis severity

  Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation

Study Arms (24)

Predictions: BMI vs. Broccoli

EXPERIMENTAL

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.

Other: Broccoli

Predictions: BMI vs. Caffeine

EXPERIMENTAL

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.

Dietary Supplement: Caffeine

Predictions: BMI vs. Coffee

EXPERIMENTAL

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.

Other: Coffee

Predictions: BMI vs. Spinach

EXPERIMENTAL

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.

Other: Spinach

Predictions: BMI vs. Vitamin A

EXPERIMENTAL

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.

Dietary Supplement: Vitamin A

Predictions: BMI vs. Vitamin C

EXPERIMENTAL

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.

Dietary Supplement: Vitamin C

Predictions: Headache vs. Vitamin B6

EXPERIMENTAL

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.

Dietary Supplement: Vitamin B6

Predictions: Headache vs. Vitamin C

EXPERIMENTAL

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.

Dietary Supplement: Vitamin C

Predictions: Headache vs. Nicotinamide

EXPERIMENTAL

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.

Dietary Supplement: Nicotinamide

Predictions: Headache vs. Axon Eyewear

EXPERIMENTAL

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.

Device: Axon Eyewear

Predictions: Rhinitis vs Broccoli

EXPERIMENTAL

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.

Other: Broccoli

Predictions: Rhinitis vs Caffeine

EXPERIMENTAL

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.

Dietary Supplement: Caffeine

Predictions: Rhinitis vs Chocolate

EXPERIMENTAL

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.

Other: Chocolate

Predictions: Rhinitis vs Coffee

EXPERIMENTAL

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.

Other: Coffee

Predictions: Rhinitis vs Vitamin A

EXPERIMENTAL

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.

Dietary Supplement: Vitamin A

Predictions: Insomnia vs Axon Eyewear

EXPERIMENTAL

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.

Device: Axon Eyewear

Predictions: Insomnia vs Vitamin A

EXPERIMENTAL

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.

Dietary Supplement: Vitamin A

Predictions: Insomnia vs Vitamin E

EXPERIMENTAL

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.

Dietary Supplement: Vitamin E

Predictions: Insomnia vs Nicotinamide

EXPERIMENTAL

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.

Dietary Supplement: Nicotinamide

Predictions: Insomnia vs Vitamin D3

EXPERIMENTAL

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.

Dietary Supplement: Vitamin D3

Predictions: Joint pain vs Broccoli

EXPERIMENTAL

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.

Other: Broccoli

Predictions: Joint pain vs Caffeine

EXPERIMENTAL

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.

Dietary Supplement: Caffeine

Predictions: Joint pain vs Coffee

EXPERIMENTAL

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.

Other: Coffee

Predictions: Joint pain vs Spinach

EXPERIMENTAL

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.

Other: Spinach

Interventions

Vitamin A DIETARY_SUPPLEMENT

Subjects will be asked to increase vitamin A intake by 8000 International Units per day.

Also known as: Retinol, Retinoic acid

Predictions: BMI vs. Vitamin A; Predictions: Insomnia vs Vitamin A; Predictions: Rhinitis vs Vitamin A

Vitamin B6 DIETARY_SUPPLEMENT

Subjects will be asked to increase vitamin B6 intake by 50 mg per day.

Also known as: Pyridoxine

Predictions: Headache vs. Vitamin B6

Vitamin C DIETARY_SUPPLEMENT

Subjects will be asked to increase vitamin C intake by 500 mg per day.

Also known as: Ascorbic acid

Predictions: BMI vs. Vitamin C; Predictions: Headache vs. Vitamin C

Nicotinamide DIETARY_SUPPLEMENT

Subjects will be asked to increase Nicotinamide intake by 500 mg per day.

Also known as: Niacinamide

Predictions: Headache vs. Nicotinamide; Predictions: Insomnia vs Nicotinamide

Vitamin D3 DIETARY_SUPPLEMENT

Subjects will be asked to increase Vitamin D3 intake by 1000 International Units per day.

Also known as: Cholecalciferol

Predictions: Insomnia vs Vitamin D3

Vitamin E DIETARY_SUPPLEMENT

Subjects will be asked to increase vitamin E intake by 400 International Units per day.

Also known as: α-tocopherol

Predictions: Insomnia vs Vitamin E

Broccoli OTHER

Subjects will be asked to increase broccoli intake by 8 fluid ounces (\~91 grams) per day.

Also known as: Brassica oleracea

Predictions: BMI vs. Broccoli; Predictions: Joint pain vs Broccoli; Predictions: Rhinitis vs Broccoli

Spinach OTHER

Subjects will be asked to increase spinach intake by 8 fluid ounces (\~30 grams) per day.

Also known as: Spinacia oleracea

Predictions: BMI vs. Spinach; Predictions: Joint pain vs Spinach

Caffeine DIETARY_SUPPLEMENT

Subjects will be asked to increase caffeine intake by taking 200mg caffeine orally once per day.

Also known as: 1,3,7-Trimethylpurine-2,6-dione

Predictions: BMI vs. Caffeine; Predictions: Joint pain vs Caffeine; Predictions: Rhinitis vs Caffeine

Coffee OTHER

Subjects will be asked to increase coffee intake by drinking 2 cups (177 mL each) of coffee per day.

Predictions: BMI vs. Coffee; Predictions: Joint pain vs Coffee; Predictions: Rhinitis vs Coffee

Axon Eyewear DEVICE

Subjects will be asked to utilize the therapeutic eyewear when exposed to bright or fluorescent light.

Predictions: Headache vs. Axon Eyewear; Predictions: Insomnia vs Axon Eyewear

Chocolate OTHER

Subjects will be asked to increase chocolate intake by eating 57g per day.

Predictions: Rhinitis vs Chocolate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Verifomics LLC: lead

Study Sites (1)

Verifomics, LLC

Dallas, Texas, 75219, United States

Location

Related Links

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

MeSH Terms

Conditions

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

Interventions

Vitamin A; Tretinoin; Vitamin B 6; Pyridoxine; Ascorbic Acid; Niacinamide; Cholecalciferol; Vitamin E; alpha-Tocopherol; Caffeine; Coffee; Chocolate

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Signs and Symptoms, Respiratory; Respiration Disorders; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Joint Diseases; Musculoskeletal Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors; Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates; Nicotinic Acids; Acids, Heterocyclic; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tocopherols; Xanthines; Alkaloids; Purinones; Purines; Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Food

Study Officials

• Brody Holohan, PhD

  Verifomics LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: May 3, 2016
• Study Start: March 1, 2016
• Primary Completion: November 23, 2016
• Study Completion: November 23, 2016
• Last Updated: October 2, 2017

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)