Overview

This trial is active, not recruiting.

Condition healthy
Treatments phosphatidylcholine, betaine
Sponsor University of Colorado, Denver
Start date April 2015
End date June 2017
Trial size 10 participants
Trial identifier NCT02403804, 14-1783, UL1TR001082

Summary

The goal is to assess whether, in adult women during the luteal phase of their menstrual cycle, supplementing their diet with either phosphatidylcholine or betaine increases their serum choline levels.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification bio-availability study
Intervention model single group assignment
Masking open label
Arm
(Other)
All 3 weeks will occur during luteal phase of menstrual cycle with a two-to-three week washout period between weeks. Week 1: Phosphatidylcholine 3600 mg qam and 2700 mg qpm Week 2: Betaine anhydrous 588 mg qam and 412 mg qpm Week 3: Betaine anhydrous 1000 mg BID
phosphatidylcholine
phosphatidylcholine 3600 mg qam and 2700 mg qpm
betaine trimethylglycine
Betaine anhydrous 588 mg qam and 412 mg qpm
betaine trimethylglycine
Betaine anhydrous 1000 mg BID

Primary Outcomes

Measure
change in serum choline
time frame: 4 hours post supplement.- baseline

Secondary Outcomes

Measure
change in serum choline
time frame: 2 hours post supplementation.- baseline
change in serum choline
time frame: 6 hours post supplementation.- baseline
change in serum choline
time frame: 8 hours post supplementation.- baseline
change in serum choline
time frame: 10 hours post supplementation.- baseline
change in serum choline
time frame: 12 hours post supplementation - baseline
change in serum choline
time frame: 1 week post supplementation - baseline

Eligibility Criteria

Female participants from 18 years up to 45 years old.

Inclusion Criteria: 1. premenopausal 2. No nicotine use 3. No marijuana use 4. No illicit substance use 5. Weight >= 90 pounds Exclusion Criteria: 1. self-reported body odor of unknown etiology 2. personal or family history of cystathionine beta synthase deficiency (homocystinuria) 3. personal or family history of trimethylaminuria, renal or liver disease, Parkinson's disease

Additional Information

Official title Dietary Supplementation to Increase Serum Choline Levels
Principal investigator Camille Hoffman, MD
Description Elevated maternal serum free choline has the potential to improve fetal brain development . However, in humans, choline can be metabolized by gut flora into two metabolites with adverse outcomes: trimethylurea (which causes body odor) and Trimethylamine (TMA) which is then, once absorbed, metabolized into Trimethylamine-N-Oxide (TMAO). There is some concern that TMAO may be atherogenic and thus, if elevated over an extended period of time, may increase risk for cardiac disease. Thus, while maternal choline supplementation may improve fetal brain development, there is a potential for maternal adverse effects. However, humans have an active choline metabolic pathway, and other components of the choline metabolic pathway (e.g. phosphatidylcholine and betaine) may be interchangeable with choline post absorption but are resistant to gut bacteria metabolism (i.e. serum TMA does not increase). Thus, these other compounds would be expected to increase serum but with no impact on TMA or trimethylurea levels. An initial study of phosphatidylcholine supplementation in pregnant women was consistent with this hypothesis; infant offspring demonstrated improved cerebral inhibition; while no adverse events were identified for either mother or infant. Unfortunately, because of the lipid groups incorporated into phosphatidylcholine, its molecular weight is high and reasonable doses require consuming several large capsules a day. The study represents the first attempt to determine if betaine, an alternative compound within the same metabolic pathway but with a much lower molecular weight, also increases serum choline levels. As the first step, this proposal seeks to address this in non-pregnant women. Specifically, the goals are to (a) assess whether changes in serum choline levels in response to molar equivalent supplementation of phosphatidylcholine versus betaine are similar, and (b) whether, for betaine, there is a dose response relationship between supplementation dose and serum choline levels.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Colorado, Denver.