At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Choline Nutritional Status: Development of a Biomarker Panel
In Brief
A clinical study evaluating 25% Cho diet, 50% Cho diet, and 1 other intervention for Healthy. Completed, enrolled 101 participants across 1 site.
Detailed Summary
People who eat diets low in choline 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.
Study Details
Timeline
Interventions
Subjects will consume meals containing 25% of recommended intake of Choline 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.
Subjects will consume meals containing 50% of recommended intake of Choline 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.
Subjects will consume meals containing 100% of recommended intake of Choline 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.