HealthyNCT03234062
Developing a Biomarker Panel to Assess Choline Nutritional Status
A study testing 25% Cho diet, 50% Cho diet and 100% Cho diet in people with Healthy, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
People who eat diets low in choline (LC) should deplete their choline (Cho) stores, and measurements of Cho pool size using isotope dilution should reflect this depletion. Investigators will identify a biomarker panel that correlates well with measured Cho pool size across the range of different degrees of… Read more about this study
- Who is it for?
- Ages 17 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 25% Cho diet, 50% Cho diet and 100% Cho diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2018to 18 Oct 2018
- 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 17 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 17-70 years
- In good general health as evidenced by medical history, clinical chemistries, physical exam, and BMI≤ 30
- Women who are included in the study and are of pregnancy potential will have a urine pregnancy test at the beginning and end of each dietary intervention arm and must be using birth control during the study.
Who cannot join
- using drugs or medication known to be damaging to liver or muscle at typically prescribed doses or that have the potential to alter Cho metabolism (e.g., methotrexate);
- history of hepatic, renal, or other chronic systemic disease.
- subjects with liver abnormalities (e.g.cysts) as determined by ultrasound
- current smokers
- consume >2 alcoholic beverages/d or >14/wk
- substance abusers or drug addicted
Show all 14Show fewer
- eating unusual diet that would interfere with the study
- food allergies, (e.g., soy) or any problems with eating all foods on required study diet
- using Cho-containing dietary supplements
- women who are breastfeeding, pregnant, or plan to become pregnant due to potential risk to fetus/child of low choline diet
- performing intense exercise of more than 1 hour a day or other intense muscle building exercise (such as weightlifting beyond low weight repetitions)
- Actively participating in other research study where required to exercise or ingest any food, medicine, or supplement in any manner
- claustrophobia
- has a cardiac pacemaker, artificial heart valve, metal plate, pin, or other metallic implant, intrauterine device, insulin or other drug pump, aneurysm clips, previous gunshot wound, cochlear implant or other implantable hearing device, employment history as a metalworker, or permanent cosmetic tattoos (eyeliner, eyebrow)
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Chapel Hill Nutrition Research Institute
Kannapolis, North Carolina, 28081
About this study
People who eat diets low in choline (LC) should deplete their choline (Cho) stores, and measurements of Cho pool size using isotope dilution should reflect this depletion. Investigators will identify a biomarker panel that correlates well with measured Cho pool size across the range of different degrees of depletion.The investigators propose that, as body stores of Cho diminish, cells and organs will reach the point when metabolism/function in the cell is altered, and that this will result in a progression of changes in biomarkers that reflect Cho status.
Read the detailed description
Choline (Cho) is an essential nutrient and most Americans' diets do not achieve the recommended intake. Diets low in Cho are associated with liver and muscle disease and with suboptimal fetal development, while diets too high in choline may be associated with increased risk for heart disease. Cho is a required nutrient and in 1998, an Adequate Intake (AI) and a Tolerable Upper Limit (UL) for Cho was established In 2016, the US Food and Drug Administration (FDA) set a Recommended Daily Intake (RDI) for Cho based on the AIs as part of the new Nutrition Facts label for packaged foods (published in the Federal Register on May 27, 2016; FDA-2012-N-1210-0875, Federal Register Number:2016-11867). The AI/RDI varies by age and gender, but is 550 mg/d in adolescent and adult men and 425 mg/d in adult women (more in pregnant and lactating women) and 400 mg/day for adolescent women.
There is no validated biomarker for choline status (the availability of the various forms of Cho needed to sustain optimal cellular function). Measurement of plasma Cho concentrations is not adequate as plasma choline is homeostatically regulated. Based on extensive preliminary and published data this group identified a panel of potential biomarkers that could be used to assess Cho status, and now they propose studies to validate this biomarker panel against measures of Cho pool size using isotope dilution. The largest stores of Cho are located in the liver, and mass resonance spectroscopy (MRS) of liver has been used in the past to assess Cho status in humans. This method is not practical for use as a biomarker in clinical or public health practice as it is expensive and the availability of the instrumentation is limited. Liver biopsy is risky and not practical, making measurement of hepatic Cho and Cho metabolites concentrations a poor choice for assessing Cho status.
Perhaps there is a panel of biomarkers that together will more accurately and reliably reflect Cho status. By making measurements in people fed 3 different dietary amounts of Cho for two weeks at a time, and comparing the biomarker measures to body total Cho pool size assessed using isotope dilution (a proxy for the availability of the various forms of Cho), investigators will be able to identify the combination of biomarkers and algorithm for calculating a Cho status score that best predicts total Cho pool size, and therefore predicts choline nutritional status (the availability of the various forms of Cho needed to sustain cellular function). In this pilot study, they are seeking to test a method for using stable isotope dilution to measure body choline stores, and then ask how this measure correlates with a panel of biomarkers in plasma and with liver fat measured using Fibroscan®. Using isotope dilution can provide an estimate of the size of the body pool of Cho. Our proposed method is conceptually similar to the method for measuring total body water from a bolus dose of labeled water. Similar methodology was used recently in studies of metabolic flux of Cho in pregnant women. Isotope dilution is a well-established method used to estimate pool size for other nutrients, such as vitamin A. Similar to vitamin A, the major storage pools for Cho are in the liver, and ingested Cho is rapidly absorbed and accumulated by liver. This pilot study tests a method for using stable isotope dilution to measure body choline stores, and it correlates this measure with a panel of biomarkers in plasma and with liver fat measured using Fibroscan®. People who eat diets low in choline should deplete their choline (Cho) stores, and measurement of Cho pool size using isotope dilution should reflect this depletion. The investigator will identify a biomarker panel that correlates well with measured Cho pool size across the range of different degrees of depletion. MRS/MRI scans will also be performed to investigate correlation between these "gold standard" measures and the other methods described above.
Participants will be consume meals we provide in two week dietary intervals with 3 different levels of choline with 2 week washout periods between those dietary intervals. Participants will receive 100% of the recommended intake (RDI) of Cho (550mg Cho/day); 50% of the RDI of Cho (275mg/day); and 25% of the RDI of Cho (137.5mg/day). The meal order will be randomly assigned and all participants will receive all diets at some point in the study. There will be a minimum of a two week washout between diet intervals. Both participants and researchers will be blinded to the diet order.
Participants will have brief exercise challenges (Biodex) to assess muscle function as an additional predictor of choline status.
To validate our isotope dilution and Fibroscan measures participants will also complete MRI/MRS scans.
Saliva samples, urine, and stool samples will be collected.
- Conditions
- Healthy
- Being tested
- 25% Cho diet, 50% Cho diet, 100% Cho diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25% Cho dietOther
Also called 137.5mg Choline/day
Subjects will consume meals containing 25% of the recommended intake of Choline (137.5 mg Choline/day) for 2 weeks. On day 12 of the diet period, subjects will consume 250 mg of Cho in the form of Cho chloride-(trimethyl-d9, 9%, Cambridge Isotope Laboratories, Tewksbury, Massachusetts, (USA), as a bolus.
50% Cho dietOther
Also called 275mg Choline/day
Subjects will consume meals containing 50% of the recommended intake of Choline (275 mg Choline/day) for 2 weeks. On day 12 of the diet period, subjects will consume 250 mg of Cho in the form of Cho chloride-(trimethyl-d9, 9%, Cambridge Isotope Laboratories, Tewksbury, Massachusetts, (USA), as a bolus.
100% Cho dietOther
Also called 550mg Choline/day
Subjects will consume meals containing 100% of the recommended intake of Choline (550 mg Choline/day) for 2 weeks. On day 12 of the diet period, subjects will consume 250 mg of Cho in the form of Cho chloride-(trimethyl-d9, 9%, Cambridge Isotope Laboratories, Tewksbury, Massachusetts, (USA), as a bolus.
| Study group | Role | What they receive |
|---|---|---|
| 25%Cho, 50%Cho, 100%Cho | Experimental | Diets containing 137.5mg (25% Cho diet), 275mg (50% Cho diet), and 550mg (100% Cho diet) will be given in that order for two weeks each with 2 weeks of washout between. Receives: Other: 25% Cho diet; Other: 50% Cho diet; Other: 100% Cho diet |
| 25% Cho, 100% Cho, 50% Cho | Experimental | Diets containing 137.5mg (25% Cho diet) , 550mg (100% Cho diet), and 275mg Cho (50% Cho diet) will be given in that order for two weeks each with 2 weeks of washout between. Receives: Other: 25% Cho diet; Other: 50% Cho diet; Other: 100% Cho diet |
| 50% Cho, 25% Cho, 100% Cho | Experimental | Diets containing 275mg (50% Cho diet), 137.5mg (25% Cho diet), and 550mg Cho (100% Cho diet) will be given in that order for two weeks each with 2 weeks of washout between. Receives: Other: 25% Cho diet; Other: 50% Cho diet; Other: 100% Cho diet |
| 50% Cho, 100% Cho, 25% Cho | Experimental | Diets containing 275mg (50% Cho diet), 550mg (100% Cho diet), and 137.5mg Cho (25% Cho diet) will be given in that order for two weeks each with 2 weeks of washout between. Receives: Other: 25% Cho diet; Other: 50% Cho diet; Other: 100% Cho diet |
| 100% Cho, 25% Cho, 50% Cho | Experimental | Diets containing 550mg (100% Cho diet), 137.5mg (25% Cho diet), and 275mg Cho (50% Cho diet) will be given in that order for two weeks each with 2 weeks of washout between. Receives: Other: 25% Cho diet; Other: 50% Cho diet; Other: 100% Cho diet |
| 100% Cho, 50% Cho, 25% Cho | Experimental | Diets containing 550mg (100% Cho diet), 275mg (50% Cho diet), and 137.5mg Cho (25% Cho diet) will be given in that order for two weeks each with 2 weeks of washout between. Receives: Other: 25% Cho diet; Other: 50% Cho diet; Other: 100% Cho diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in biomarker panel measures and MRS/MRI scans correlated to different dietary choline levels
The investigator will evaluate direct measures of Choline derived pools and using isotope dilution will provide an estimate of the size of the body pool of choline, while also profiling choline-related metabolites. MRS/MRI will assess Cho compounds in liver and fatty liver (also used to validate Fibroscan) to confirm measures utilizing isotope dilution.
Measured: Samples taken on Day 12 and Day 14
Secondary outcomes (2)
Genotyping for choline metabolism single nucleotide polymorphisms
Investigators will ask whether single nucleotide polymorphisms that create inefficiencies in choline metabolism are also associated with decreased choline pool size. SNPs acquired through DNA collection from saliva.
Measured: At baseline visit
Metabolomic profiling to enhance Cho status score
Untargeted metabolic profiling completed on plasma and urine samples to explore whether there are metabolites detected that enhance Cho status score so that it better predicts Cho pool size as measured using isotope dilution and/or MRS/MRI
Measured: Samples taken on Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study start15 Feb 2018
- Primary completion18 Oct 2018
- Study completion18 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Healthy volunteers (n=20), will consume meals, provided by the investigator, in two week intervals with 3 different levels of choline (Cho). Participants will receive 100% of the recommended daily intake (RDI) of Cho (550 mg Cho/day); 50% of the RDI of Cho (275mg/day); and 25% of the RDI of Cho (137.5 mg/day). The meal order will be randomly assigned and all participants will receive all diets at some point in the study. There will be a minimum of a two week washout between diet intervals where participants return to their regular diets. Both participants and researchers will be blinded to the diet order.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven H Zeisel, MD, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03234062
- Sponsor's protocol ID
- 17-0321
- Status last verified
- Dec 2019
- First submitted
- 19 Jul 2017
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Biomarker Panel to Assess Choline Nutritional Status
- ClinicalTrials.gov ID
- NCT03234062
- Acronym / sponsor ID
- 17-0321
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 18 Oct 2018 (actual)
- Study completion
- 18 Oct 2018 (actual)
- First posted
- 31 Jul 2017 (actual)
- 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.
People who eat diets low in choline (LC) should deplete their choline (Cho) stores, and measurements of Cho pool size using isotope dilution should reflect this depletion. Investigators will identify a biomarker panel that correlates well with measured Cho pool size across the range of different degrees of depletion.The investigators propose that, as body stores of Cho diminish, cells and organs will reach the point when metabolism/function in the cell is altered, and that this will result in a progression of changes in biomarkers that reflect Cho status.
Detailed description
Choline (Cho) is an essential nutrient and most Americans' diets do not achieve the recommended intake. Diets low in Cho are associated with liver and muscle disease and with suboptimal fetal development, while diets too high in choline may be associated with increased risk for heart disease. Cho is a required nutrient and in 1998, an Adequate Intake (AI) and a Tolerable Upper Limit (UL) for Cho was established In 2016, the US Food and Drug Administration (FDA) set a Recommended Daily Intake (RDI) for Cho based on the AIs as part of the new Nutrition Facts label for packaged foods (published in the Federal Register on May 27, 2016; FDA-2012-N-1210-0875, Federal Register Number:2016-11867). The AI/RDI varies by age and gender, but is 550 mg/d in adolescent and adult men and 425 mg/d in adult women (more in pregnant and lactating women) and 400 mg/day for adolescent women.
There is no validated biomarker for choline status (the availability of the various forms of Cho needed to sustain optimal cellular function). Measurement of plasma Cho concentrations is not adequate as plasma choline is homeostatically regulated. Based on extensive preliminary and published data this group identified a panel of potential biomarkers that could be used to assess Cho status, and now they propose studies to validate this biomarker panel against measures of Cho pool size using isotope dilution. The largest stores of Cho are located in the liver, and mass resonance spectroscopy (MRS) of liver has been used in the past to assess Cho status in humans. This method is not practical for use as a biomarker in clinical or public health practice as it is expensive and the availability of the instrumentation is limited. Liver biopsy is risky and not practical, making measurement of hepatic Cho and Cho metabolites concentrations a poor choice for assessing Cho status.
Perhaps there is a panel of biomarkers that together will more accurately and reliably reflect Cho status. By making measurements in people fed 3 different dietary amounts of Cho for two weeks at a time, and comparing the biomarker measures to body total Cho pool size assessed using isotope dilution (a proxy for the availability of the various forms of Cho), investigators will be able to identify the combination of biomarkers and algorithm for calculating a Cho status score that best predicts total Cho pool size, and therefore predicts choline nutritional status (the availability of the various forms of Cho needed to sustain cellular function). In this pilot study, they are seeking to test a method for using stable isotope dilution to measure body choline stores, and then ask how this measure correlates with a panel of biomarkers in plasma and with liver fat measured using Fibroscan®. Using isotope dilution can provide an estimate of the size of the body pool of Cho. Our proposed method is conceptually similar to the method for measuring total body water from a bolus dose of labeled water. Similar methodology was used recently in studies of metabolic flux of Cho in pregnant women. Isotope dilution is a well-established method used to estimate pool size for other nutrients, such as vitamin A. Similar to vitamin A, the major storage pools for Cho are in the liver, and ingested Cho is rapidly absorbed and accumulated by liver. This pilot study tests a method for using stable isotope dilution to measure body choline stores, and it correlates this measure with a panel of biomarkers in plasma and with liver fat measured using Fibroscan®. People who eat diets low in choline should deplete their choline (Cho) stores, and measurement of Cho pool size using isotope dilution should reflect this depletion. The investigator will identify a biomarker panel that correlates well with measured Cho pool size across the range of different degrees of depletion. MRS/MRI scans will also be performed to investigate correlation between these "gold standard" measures and the other methods described above.
Participants will be consume meals we provide in two week dietary intervals with 3 different levels of choline with 2 week washout periods between those dietary intervals. Participants will receive 100% of the recommended intake (RDI) of Cho (550mg Cho/day); 50% of the RDI of Cho (275mg/day); and 25% of the RDI of Cho (137.5mg/day). The meal order will be randomly assigned and all participants will receive all diets at some point in the study. There will be a minimum of a two week washout between diet intervals. Both participants and researchers will be blinded to the diet order.
Participants will have brief exercise challenges (Biodex) to assess muscle function as an additional predictor of choline status.
To validate our isotope dilution and Fibroscan measures participants will also complete MRI/MRS scans.
Saliva samples, urine, and stool samples will be collected.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Healthy volunteers (n=20), will consume meals, provided by the investigator, in two week intervals with 3 different levels of choline (Cho). Participants will receive 100% of the recommended daily intake (RDI) of Cho (550 mg Cho/day); 50% of the RDI of Cho (275mg/day); and 25% of the RDI of Cho (137.5 mg/day). The meal order will be randomly assigned and all participants will receive all diets at some point in the study. There will be a minimum of a two week washout between diet intervals where participants return to their regular diets. Both participants and researchers will be blinded to the diet order.
| Arm | Type | Receives |
|---|---|---|
| 25%Cho, 50%Cho, 100%Cho | Experimental | Other: 25% Cho diet, Other: 50% Cho diet, Other: 100% Cho dietDiets containing 137.5mg (25% Cho diet), 275mg (50% Cho diet), and 550mg (100% Cho diet) will be given in that order for two weeks each with 2 weeks of washout between. |
| 25% Cho, 100% Cho, 50% Cho | Experimental | Other: 25% Cho diet, Other: 50% Cho diet, Other: 100% Cho dietDiets containing 137.5mg (25% Cho diet) , 550mg (100% Cho diet), and 275mg Cho (50% Cho diet) will be given in that order for two weeks each with 2 weeks of washout between. |
| 50% Cho, 25% Cho, 100% Cho | Experimental | Other: 25% Cho diet, Other: 50% Cho diet, Other: 100% Cho dietDiets containing 275mg (50% Cho diet), 137.5mg (25% Cho diet), and 550mg Cho (100% Cho diet) will be given in that order for two weeks each with 2 weeks of washout between. |
| 50% Cho, 100% Cho, 25% Cho | Experimental | Other: 25% Cho diet, Other: 50% Cho diet, Other: 100% Cho dietDiets containing 275mg (50% Cho diet), 550mg (100% Cho diet), and 137.5mg Cho (25% Cho diet) will be given in that order for two weeks each with 2 weeks of washout between. |
| 100% Cho, 25% Cho, 50% Cho | Experimental | Other: 25% Cho diet, Other: 50% Cho diet, Other: 100% Cho dietDiets containing 550mg (100% Cho diet), 137.5mg (25% Cho diet), and 275mg Cho (50% Cho diet) will be given in that order for two weeks each with 2 weeks of washout between. |
| 100% Cho, 50% Cho, 25% Cho | Experimental | Other: 25% Cho diet, Other: 50% Cho diet, Other: 100% Cho dietDiets containing 550mg (100% Cho diet), 275mg (50% Cho diet), and 137.5mg Cho (25% Cho diet) will be given in that order for two weeks each with 2 weeks of washout between. |
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 17-70 years
- In good general health as evidenced by medical history, clinical chemistries, physical exam, and BMI≤ 30
- Women who are included in the study and are of pregnancy potential will have a urine pregnancy test at the beginning and end of each dietary intervention arm and must be using birth control during the study.
Key exclusion criteria (14 listed)
- using drugs or medication known to be damaging to liver or muscle at typically prescribed doses or that have the potential to alter Cho metabolism (e.g., methotrexate);
- history of hepatic, renal, or other chronic systemic disease.
- subjects with liver abnormalities (e.g.cysts) as determined by ultrasound
- current smokers
- consume >2 alcoholic beverages/d or >14/wk
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 |
|---|---|---|
| 25% Cho dietAlso: 137.5mg Choline/daySubjects will consume meals containing 25% of the recommended intake of Choline (137.5 mg Choline/day) for 2 weeks. On day 12 of the diet period, subjects will consume 250 mg of Cho in the form of Cho chloride-(trimethyl-d9, 9%, Cambridge Isotope Laboratories, Tewksbury, Massachusetts, (USA), as a bolus. | Other | 100% Cho, 25% Cho, 50% Cho, 100% Cho, 50% Cho, 25% Cho, 25% Cho, 100% Cho, 50% Cho, 25%Cho, 50%Cho, 100%Cho, 50% Cho, 100% Cho, 25% Cho, 50% Cho, 25% Cho, 100% Cho |
| 50% Cho dietAlso: 275mg Choline/daySubjects will consume meals containing 50% of the recommended intake of Choline (275 mg Choline/day) for 2 weeks. On day 12 of the diet period, subjects will consume 250 mg of Cho in the form of Cho chloride-(trimethyl-d9, 9%, Cambridge Isotope Laboratories, Tewksbury, Massachusetts, (USA), as a bolus. | Other | 100% Cho, 25% Cho, 50% Cho, 100% Cho, 50% Cho, 25% Cho, 25% Cho, 100% Cho, 50% Cho, 25%Cho, 50%Cho, 100%Cho, 50% Cho, 100% Cho, 25% Cho, 50% Cho, 25% Cho, 100% Cho |
| 100% Cho dietAlso: 550mg Choline/daySubjects will consume meals containing 100% of the recommended intake of Choline (550 mg Choline/day) for 2 weeks. On day 12 of the diet period, subjects will consume 250 mg of Cho in the form of Cho chloride-(trimethyl-d9, 9%, Cambridge Isotope Laboratories, Tewksbury, Massachusetts, (USA), as a bolus. | Other | 100% Cho, 25% Cho, 50% Cho, 100% Cho, 50% Cho, 25% Cho, 25% Cho, 100% Cho, 50% Cho, 25%Cho, 50%Cho, 100%Cho, 50% Cho, 100% Cho, 25% Cho, 50% Cho, 25% Cho, 100% Cho |
Primary outcome
Change in biomarker panel measures and MRS/MRI scans correlated to different dietary choline levels
Time frame: Samples taken on Day 12 and Day 14
The investigator will evaluate direct measures of Choline derived pools and using isotope dilution will provide an estimate of the size of the body pool of choline, while also profiling choline-related metabolites. MRS/MRI will assess Cho compounds in liver and fatty liver (also used to validate Fibroscan) to confirm measures utilizing isotope dilution.
2 secondary outcomes
Genotyping for choline metabolism single nucleotide polymorphisms
Time frame: At baseline visit
Metabolomic profiling to enhance Cho status score
Time frame: Samples taken on Day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
- 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.
Steven H Zeisel, MD, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 25% Cho diet, 50% Cho diet and 100% Cho diet in people with Healthy, run by University of North Carolina, Chapel Hill 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 14 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: finished, as of the sponsor's last update on 3 Dec 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in biomarker panel measures and MRS/MRI scans correlated to different dietary choline levels (time frame: Samples taken on Day 12 and Day 14). 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 3 Dec 2019.