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Recruiting and financial constraints
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin A | Dietary Supplement | Subjects will be asked to increase vitamin A intake by 8000 International Units per day. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brody Holohan, PhD | Verifomics LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Verifomics, LLC | Dallas | Texas | 75219 | United States |
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| Label | URL |
|---|---|
| Website that begins the remote enrollment and participation process. Advertising material present on the site has been approved by the institutional review board. | View source |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Vitamin B6 | Dietary Supplement | Subjects will be asked to increase vitamin B6 intake by 50 mg per day. |
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| Vitamin C | Dietary Supplement | Subjects will be asked to increase vitamin C intake by 500 mg per day. |
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| Nicotinamide | Dietary Supplement | Subjects will be asked to increase Nicotinamide intake by 500 mg per day. |
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| Vitamin D3 | Dietary Supplement | Subjects will be asked to increase Vitamin D3 intake by 1000 International Units per day. |
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| Vitamin E | Dietary Supplement | Subjects will be asked to increase vitamin E intake by 400 International Units per day. |
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| Broccoli | Other | Subjects will be asked to increase broccoli intake by 8 fluid ounces (~91 grams) per day. |
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| Spinach | Other | Subjects will be asked to increase spinach intake by 8 fluid ounces (~30 grams) per day. |
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| Caffeine | Dietary Supplement | Subjects will be asked to increase caffeine intake by taking 200mg caffeine orally once per day. |
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| Coffee | Other | Subjects will be asked to increase coffee intake by drinking 2 cups (177 mL each) of coffee per day. |
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| Axon Eyewear | Device | Subjects will be asked to utilize the therapeutic eyewear when exposed to bright or fluorescent light. |
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| Chocolate | Other | Subjects will be asked to increase chocolate intake by eating 57g per day. |
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| 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 |
| Change in rhinitis frequency | Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation |
| Change in insomnia frequency | Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation |
| Change in insomnia severity | Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation |
| Change in joint pain severity | Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation |
| Change in joint pain frequency | Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation |
| "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.. |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D012220 | Rhinitis |
| D065631 | Rhinitis, Allergic |
| D012135 | Respiratory Sounds |
| D004417 | Dyspnea |
| D006261 | Headache |
| D008881 | Migraine Disorders |
| D001168 | Arthritis |
| D018771 | Arthralgia |
| D001008 | Anxiety Disorders |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D012892 | Sleep Deprivation |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012120 | Respiration Disorders |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| D014801 | Vitamin A |
| D014212 | Tretinoin |
| D025101 | Vitamin B 6 |
| D011736 | Pyridoxine |
| D001205 | Ascorbic Acid |
| D009536 | Niacinamide |
| D002762 | Cholecalciferol |
| D014810 | Vitamin E |
| D024502 | alpha-Tocopherol |
| D002110 | Caffeine |
| D003069 | Coffee |
| D000069956 | Chocolate |
| ID | Term |
|---|---|
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D004224 | Diterpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| D010847 | Picolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D024505 | Tocopherols |
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D011688 | Purinones |
| D011687 | Purines |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D005502 | Food |
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