N/A
N=101
Choline Nutritional Status: Development of a Biomarker Panel
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT03726671 ↗Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: Ratio of Liver Choline Pool Size by Isotope Dilution — 0.02357; 0.02403; 0.02184; 0.00023 isotopic enrichment ratio — p=0.0247
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 25% Cho diet (Other); 50% Cho diet (Other); 100% Cho diet (Other)
- Age
- Pediatric, Adult, Older Adult · 17+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ratio of Liver Choline Pool Size by Isotope Dilution |
0.02357; 0.02403; 0.02184; 0.00023; 0.00132; 0.00191 | 0.0247 sig |
| PRIMARY Difference in Choline Deficiency Signature |
57; 47; 23 | <0.001 sig |
| PRIMARY Comparison of Choline Pool Size Between Participants With and Without Choline Metabolites Signature During Cho Depletion |
0.0234; 0.0241; -0.0005; 0.0025; 0.0115; 0.0118 | 0.6985 |
| PRIMARY Ion Abundance (Intensity) of Metabolites as Indicators of the Intake of 25%, 50%, or 100% Choline in the Diet. The Ratio of the Intensity of Metabolite Signals for Each Dietary Group Can be Calculated and Correlated With the Level of Choline in the Diet |
1228784.33; 1178435.52; 1012630.35; 104096.43; 99820.22; 80011.86 | <0.049 sig |
| PRIMARY Comparison of Choline Pool Size Between Participants With Different Genotypes in Phosphatidylethanolamine-N-methyltransferase (PEMT) Single Nucleotide Polymorphism (SNP rs12325817) |
0.0259; 0.0201; 0.0261; 0.0244; 0.0224; 0.0262 | 0.9567 |
| PRIMARY Change in Liver Fat Content Based on CAP Values |
0.0208; 0.6958; 0.0135 | 0.0842 |
| SECONDARY Validation of Isotope Dilution Method to Assess Choline Pool Size by Magnetic Resonance Spectroscopy (MRS) |
8.4; 7.8; 11.2 | 0.2351 |
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.
Eligibility Criteria
Inclusion Criteria
- Provision of signed and dated informed consent form
- Weigh 130-177lbs (or if over 177 must have BMI under 28)
- 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 or if over 177lbs with a BMI under 28
- 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 some form of 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
- have been screened for this study between August and March and have not provided proof of flu vaccination prior to enrollment
Data sourced from ClinicalTrials.gov (NCT03726671). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.