Choline Nutritional Status: Development of a Biomarker Panel

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.

Conditions

• Healthy

Interventions

OTHER

25% Cho diet

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.

OTHER

50% Cho diet

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.

OTHER

100% Cho diet

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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Steven H. Zeisel, MD, PhD · UNC Chapel Hill - Nutrition Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

17 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-11-01

Primary Completion

2021-10-20

Completion

2021-10-20

Countries

• United States

Study Locations