ObesityNCT02758990
Interventional Testing of Gene-environment Interactions Via the Verifomics Mobile Application
A study testing Vitamin A, Vitamin B6 and Vitamin C in people with Obesity and Rhinitis, run by Verifomics LLC at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Rhinitis, Rhinitis, Allergic
- What is being tested?
- Vitamin A, Vitamin B6 and Vitamin C
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 23 Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Obesity, Rhinitis, Rhinitis, Allergic, Respiratory Sounds, Dyspnea, Headache
- Being tested
- Vitamin A, Vitamin B6, Vitamin C, Nicotinamide, Vitamin D3
- Keywords
- Food, Nutrigenomics, Precision Medicine, Pharmacogenetics, Lifestyle
- Medical subject headings
- Obesity, Rhinitis, Rhinitis, Allergic, Respiratory Sounds, Dyspnea, Headache, Migraine Disorders, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin ADietary supplement
Also called Retinol, Retinoic acid
Subjects will be asked to increase vitamin A intake by 8000 International Units per day.
Vitamin B6Dietary supplement
Also called Pyridoxine
Subjects will be asked to increase vitamin B6 intake by 50 mg per day.
Vitamin CDietary supplement
Also called Ascorbic acid
Subjects will be asked to increase vitamin C intake by 500 mg per day.
NicotinamideDietary supplement
Also called Niacinamide
Subjects will be asked to increase Nicotinamide intake by 500 mg per day.
Vitamin D3Dietary supplement
Also called Cholecalciferol
Subjects will be asked to increase Vitamin D3 intake by 1000 International Units per day.
Vitamin EDietary supplement
Also called α-tocopherol
Subjects will be asked to increase vitamin E intake by 400 International Units per day.
BroccoliOther
Also called Brassica oleracea
Subjects will be asked to increase broccoli intake by 8 fluid ounces (~91 grams) per day.
SpinachOther
Also called Spinacia oleracea
Subjects will be asked to increase spinach intake by 8 fluid ounces (~30 grams) per day.
CaffeineDietary supplement
Also called 1,3,7-Trimethylpurine-2,6-dione
Subjects will be asked to increase caffeine intake by taking 200mg caffeine orally once per day.
CoffeeOther
Subjects will be asked to increase coffee intake by drinking 2 cups (177 mL each) of coffee per day.
Axon EyewearDevice
Subjects will be asked to utilize the therapeutic eyewear when exposed to bright or fluorescent light.
ChocolateOther
Subjects will be asked to increase chocolate intake by eating 57g per day.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Spinach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Change in body mass index
Measured: Assessed 30 days after enrollment, comparing value at enrollment to value after 30 days of participation
Change in headache severity
Measured: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Change in headache frequency
Measured: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Change in rhinitis severity
Measured: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Change in rhinitis frequency
Measured: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Change in insomnia frequency
Measured: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Change in insomnia severity
Measured: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Change in joint pain severity
Measured: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Change in joint pain frequency
Measured: 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.
Measured: 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..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study startMar 2016
- Primary completion23 Nov 2016
- Study completion23 Nov 2016
Why it stopped: Recruiting and financial constraints
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Verifomics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brody Holohan, PhD, Principal investigator, Verifomics LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02758990
- Sponsor's protocol ID
- 001
- Status last verified
- Oct 2016
- First submitted
- 26 Apr 2016
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Testing of Gene-environment Interactions Via the Verifomics Mobile Application
- ClinicalTrials.gov ID
- NCT02758990
- Acronym / sponsor ID
- 001
- Conditions
- Obesity, Rhinitis, Rhinitis, Allergic, Respiratory Sounds, Dyspnea, Headache
- Keywords
- Food, Nutrigenomics, Precision Medicine, Pharmacogenetics, Lifestyle
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruiting and financial constraints
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Verifomics LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- 23 Nov 2016 (actual)
- Study completion
- 23 Nov 2016 (actual)
- First posted
- 3 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 24
| Arm | Type | Receives |
|---|---|---|
| Predictions: BMI vs. Broccoli | Experimental | Other: BroccoliBMI 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. |
| Predictions: BMI vs. Caffeine | Experimental | Dietary Supplement: CaffeineBMI 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. |
| Predictions: BMI vs. Coffee | Experimental | Other: CoffeeBMI 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. |
| Predictions: BMI vs. Spinach | Experimental | Other: SpinachBMI 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. |
| Predictions: BMI vs. Vitamin A | Experimental | Dietary Supplement: Vitamin ABMI 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. |
| Predictions: BMI vs. Vitamin C | Experimental | Dietary Supplement: Vitamin CBMI 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. |
| Predictions: Headache vs. Vitamin B6 | Experimental | Dietary Supplement: Vitamin B6Headache 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. |
| Predictions: Headache vs. Vitamin C | Experimental | Dietary Supplement: Vitamin CHeadache 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. |
| Predictions: Headache vs. Nicotinamide | Experimental | Dietary Supplement: NicotinamideHeadache 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. |
| Predictions: Headache vs. Axon Eyewear | Experimental | Device: Axon EyewearHeadache 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. |
| Predictions: Rhinitis vs Broccoli | Experimental | Other: BroccoliRhinitis 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. |
| Predictions: Rhinitis vs Caffeine | Experimental | Dietary Supplement: CaffeineRhinitis 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. |
| Predictions: Rhinitis vs Chocolate | Experimental | Other: ChocolateRhinitis 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. |
| Predictions: Rhinitis vs Coffee | Experimental | Other: CoffeeRhinitis 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. |
| Predictions: Rhinitis vs Vitamin A | Experimental | Dietary Supplement: Vitamin ARhinitis 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. |
| Predictions: Insomnia vs Axon Eyewear | Experimental | Device: Axon EyewearSleep 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. |
| Predictions: Insomnia vs Vitamin A | Experimental | Dietary Supplement: Vitamin ASleep 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. |
| Predictions: Insomnia vs Vitamin E | Experimental | Dietary Supplement: Vitamin ESleep 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. |
| Predictions: Insomnia vs Nicotinamide | Experimental | Dietary Supplement: NicotinamideSleep 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. |
| Predictions: Insomnia vs Vitamin D3 | Experimental | Dietary Supplement: Vitamin D3Sleep 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. |
| Predictions: Joint pain vs Broccoli | Experimental | Other: BroccoliJoint 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. |
| Predictions: Joint pain vs Caffeine | Experimental | Dietary Supplement: CaffeineJoint 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. |
| Predictions: Joint pain vs Coffee | Experimental | Other: CoffeeJoint 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. |
| Predictions: Joint pain vs Spinach | Experimental | Other: SpinachJoint 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin AAlso: Retinol, Retinoic acidSubjects will be asked to increase vitamin A intake by 8000 International Units per day. | Dietary supplement | Predictions: BMI vs. Vitamin A, Predictions: Insomnia vs Vitamin A, Predictions: Rhinitis vs Vitamin A |
| Vitamin B6Also: PyridoxineSubjects will be asked to increase vitamin B6 intake by 50 mg per day. | Dietary supplement | Predictions: Headache vs. Vitamin B6 |
| Vitamin CAlso: Ascorbic acidSubjects will be asked to increase vitamin C intake by 500 mg per day. | Dietary supplement | Predictions: BMI vs. Vitamin C, Predictions: Headache vs. Vitamin C |
| NicotinamideAlso: NiacinamideSubjects will be asked to increase Nicotinamide intake by 500 mg per day. | Dietary supplement | Predictions: Headache vs. Nicotinamide, Predictions: Insomnia vs Nicotinamide |
| Vitamin D3Also: CholecalciferolSubjects will be asked to increase Vitamin D3 intake by 1000 International Units per day. | Dietary supplement | Predictions: Insomnia vs Vitamin D3 |
| Vitamin EAlso: α-tocopherolSubjects will be asked to increase vitamin E intake by 400 International Units per day. | Dietary supplement | Predictions: Insomnia vs Vitamin E |
| BroccoliAlso: Brassica oleraceaSubjects will be asked to increase broccoli intake by 8 fluid ounces (~91 grams) per day. | Other | Predictions: BMI vs. Broccoli, Predictions: Joint pain vs Broccoli, Predictions: Rhinitis vs Broccoli |
| SpinachAlso: Spinacia oleraceaSubjects will be asked to increase spinach intake by 8 fluid ounces (~30 grams) per day. | Other | Predictions: BMI vs. Spinach, Predictions: Joint pain vs Spinach |
| CaffeineAlso: 1,3,7-Trimethylpurine-2,6-dioneSubjects will be asked to increase caffeine intake by taking 200mg caffeine orally once per day. | Dietary supplement | Predictions: BMI vs. Caffeine, Predictions: Joint pain vs Caffeine, Predictions: Rhinitis vs Caffeine |
| CoffeeSubjects will be asked to increase coffee intake by drinking 2 cups (177 mL each) of coffee per day. | Other | Predictions: BMI vs. Coffee, Predictions: Joint pain vs Coffee, Predictions: Rhinitis vs Coffee |
| Axon EyewearSubjects will be asked to utilize the therapeutic eyewear when exposed to bright or fluorescent light. | Device | Predictions: Headache vs. Axon Eyewear, Predictions: Insomnia vs Axon Eyewear |
| ChocolateSubjects will be asked to increase chocolate intake by eating 57g per day. | Other | Predictions: Rhinitis vs Chocolate |
Primary outcome
Frequency of correct predictions
Time frame: 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
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.
11 secondary outcomes
Genotype-independent effects of substances of interest
Time frame: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Change in body mass index
Time frame: Assessed 30 days after enrollment, comparing value at enrollment to value after 30 days of participation
Change in headache severity
Time frame: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Change in headache frequency
Time frame: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Change in rhinitis severity
Time frame: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Change in rhinitis frequency
Time frame: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Change in insomnia frequency
Time frame: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Change in insomnia severity
Time frame: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Change in joint pain severity
Time frame: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
Change in joint pain frequency
Time frame: Assessed 30 days after enrollment, comparing value at enrollment to value after in the final week of participation
"Question of the day" questionnaire
Time frame: 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..
Results and safety
The study was stopped early (reason given: Recruiting and financial constraints). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
- Website that begins the remote enrollment and participation process. Advertising material present on the site has been approved by the institutional review board.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brody Holohan, PhD principal investigator
Verifomics LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin A, Vitamin B6 and Vitamin C in people with Obesity and Rhinitis, run by Verifomics LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruiting and financial constraints). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of correct predictions (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2017.