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Dietary Supplementation to Increase Serum Choline Levels

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ClinicalTrials.gov Identifier: NCT02403804
Recruitment Status : Completed
First Posted : March 31, 2015
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Phosphatidylcholine Dietary Supplement: Betaine (588 mg qam and 412 mg qpm) Dietary Supplement: Betaine (1000 mg BID) Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Dietary Supplementation to Increase Serum Choline Levels
Actual Study Start Date : April 2015
Actual Primary Completion Date : September 29, 2015
Actual Study Completion Date : September 29, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
All subjects

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

Dietary Supplement: Phosphatidylcholine
Phosphatidylcholine 3600 mg qam and 2700 mg qpm

Dietary Supplement: Betaine (588 mg qam and 412 mg qpm)
Betaine anhydrous 588 mg qam and 412 mg qpm
Other Name: Trimethylglycine

Dietary Supplement: Betaine (1000 mg BID)
Betaine anhydrous 1000 mg BID
Other Name: Trimethylglycine




Primary Outcome Measures :
  1. change in serum choline [ Time Frame: 4 hours post supplement.- baseline ]

Secondary Outcome Measures :
  1. change in serum choline [ Time Frame: 2 hours post supplementation.- baseline ]
  2. change in serum choline [ Time Frame: 6 hours post supplementation.- baseline ]
  3. change in serum choline [ Time Frame: 8 hours post supplementation.- baseline ]
  4. change in serum choline [ Time Frame: 10 hours post supplementation.- baseline ]
  5. change in serum choline [ Time Frame: 12 hours post supplementation - baseline ]
  6. change in serum choline [ Time Frame: 1 week post supplementation - baseline ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02403804


Locations
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United States, Colorado
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Camille Hoffman, MD Denver Health and Hospitals
Study Director: Randal G Ross, MD University of Colorado School of Medicine
Study Director: Ann Olincy, MD University of Colorado School of Medicine
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02403804    
Other Study ID Numbers: 14-1783
UL1TR001082 ( U.S. NIH Grant/Contract )
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020
Keywords provided by University of Colorado, Denver:
Dietary supplements
serum choline
women
Additional relevant MeSH terms:
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Betaine
Gastrointestinal Agents
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents