Healthy Clinical Trial
Official title:
Developing a Biomarker Panel to Assess Choline Nutritional Status
Verified date | December 2019 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | October 18, 2018 |
Est. primary completion date | October 18, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 17 Years to 70 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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 - 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) |
Country | Name | City | State |
---|---|---|---|
United States | UNC Chapel Hill Nutrition Research Institute | Kannapolis | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Samples taken on Day 12 and Day 14 | |
Secondary | 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. | At baseline visit | |
Secondary | 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 | Samples taken on Day 15 |
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