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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001082 | U.S. NIH Grant/Contract | View source |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phosphatidylcholine | Dietary Supplement | Phosphatidylcholine 3600 mg qam and 2700 mg qpm |
| |
| Measure | Description | Time Frame |
|---|---|---|
| change in serum choline | 4 hours post supplement.- baseline |
| Measure | Description | Time Frame |
|---|---|---|
| change in serum choline | 2 hours post supplementation.- baseline | |
| change in serum choline | 6 hours post supplementation.- baseline | |
| change in serum choline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Camille Hoffman, MD | Denver Health and Hospitals | Principal Investigator |
| Randal G Ross, MD | University of Colorado School of Medicine | Study Director |
| Ann Olincy, MD | University of Colorado School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
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| ID | Term |
|---|---|
| D010713 | Phosphatidylcholines |
| D001622 | Betaine |
| C494814 | BID protein, human |
| ID | Term |
|---|---|
| D020404 | Glycerophospholipids |
| D010712 | Phosphatidic Acids |
| D005994 | Glycerophosphates |
| D010743 | Phospholipids |
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| Betaine (588 mg qam and 412 mg qpm) |
| Dietary Supplement |
Betaine anhydrous 588 mg qam and 412 mg qpm |
|
|
| Betaine (1000 mg BID) | Dietary Supplement | Betaine anhydrous 1000 mg BID |
|
|
| 8 hours post supplementation.- baseline |
| change in serum choline | 10 hours post supplementation.- baseline |
| change in serum choline | 12 hours post supplementation - baseline |
| change in serum choline | 1 week post supplementation - baseline |
| D008563 |
| Membrane Lipids |
| D008055 | Lipids |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |