Status:
COMPLETED
Developing a Biomarker Panel to Assess Choline Nutritional Status
Lead Sponsor:
University of North Carolina, Chapel Hill
Conditions:
Healthy
Eligibility:
All Genders
17-70 years
Phase:
NA
Brief 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 ...
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 developm...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2018
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03234062
Start Date
February 15 2018
End Date
October 18 2018
Last Update
December 3 2019
Active Locations (1)
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1
UNC Chapel Hill Nutrition Research Institute
Kannapolis, North Carolina, United States, 28081