HealthyNCT02403804
Dietary Supplementation to Increase Serum Choline Levels
A study testing Phosphatidylcholine, Betaine (588 mg qam and 412 mg qpm) and Betaine (1000 mg BID) in people with Healthy, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Phosphatidylcholine, Betaine (588 mg qam and 412 mg qpm) and Betaine (1000 mg BID)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to 29 Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- premenopausal
- No nicotine use
- No marijuana use
- No illicit substance use
- Weight >= 90 pounds
Who cannot join
- self-reported body odor of unknown etiology
- personal or family history of cystathionine beta synthase deficiency (homocystinuria)
- personal or family history of trimethylaminuria, renal or liver disease, Parkinson's disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Phosphatidylcholine, Betaine (588 mg qam and 412 mg qpm), Betaine (1000 mg BID)
- Keywords
- Dietary supplements, serum choline, women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhosphatidylcholineDietary supplement
Phosphatidylcholine 3600 mg qam and 2700 mg qpm
Betaine (588 mg qam and 412 mg qpm)Dietary supplement
Also called Trimethylglycine
Betaine anhydrous 588 mg qam and 412 mg qpm
Betaine (1000 mg BID)Dietary supplement
Also called Trimethylglycine
Betaine anhydrous 1000 mg BID
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Phosphatidylcholine; Dietary Supplement: Betaine (588 mg qam and 412 mg qpm); Dietary Supplement: Betaine (1000 mg BID) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in serum choline
Measured: 4 hours post supplement.- baseline
Secondary outcomes (6)
change in serum choline
Measured: 2 hours post supplementation.- baseline
change in serum choline
Measured: 6 hours post supplementation.- baseline
change in serum choline
Measured: 8 hours post supplementation.- baseline
change in serum choline
Measured: 10 hours post supplementation.- baseline
change in serum choline
Measured: 12 hours post supplementation - baseline
change in serum choline
Measured: 1 week post supplementation - baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startApr 2015
- Primary completion29 Sep 2015
- Study completion29 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Camille Hoffman, MD, Principal investigator, Denver Health and HospitalsRandal G Ross, MD, Study director, University of Colorado School of MedicineAnn Olincy, MD, Study director, University of Colorado School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403804
- Sponsor's protocol ID
- 14-1783
- Other IDs
- UL1TR001082
- Status last verified
- Aug 2020
- First submitted
- 3 Feb 2015
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Supplementation to Increase Serum Choline Levels
- ClinicalTrials.gov ID
- NCT02403804
- Acronym / sponsor ID
- 14-1783
- Conditions
- Healthy
- Keywords
- Dietary supplements, serum choline, women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- 29 Sep 2015 (actual)
- Study completion
- 29 Sep 2015 (actual)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | Other | Dietary Supplement: Phosphatidylcholine, Dietary Supplement: Betaine (588 mg qam and 412 mg qpm), Dietary Supplement: Betaine (1000 mg BID)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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- premenopausal
- No nicotine use
- No marijuana use
- No illicit substance use
- Weight >= 90 pounds
Key exclusion criteria (3 listed)
- self-reported body odor of unknown etiology
- personal or family history of cystathionine beta synthase deficiency (homocystinuria)
- personal or family history of trimethylaminuria, renal or liver disease, Parkinson's disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhosphatidylcholinePhosphatidylcholine 3600 mg qam and 2700 mg qpm | Dietary supplement | All subjects |
| Betaine (588 mg qam and 412 mg qpm)Also: TrimethylglycineBetaine anhydrous 588 mg qam and 412 mg qpm | Dietary supplement | All subjects |
| Betaine (1000 mg BID)Also: TrimethylglycineBetaine anhydrous 1000 mg BID | Dietary supplement | All subjects |
Primary outcome
change in serum choline
Time frame: 4 hours post supplement.- baseline
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Camille Hoffman, MD principal investigator
Denver Health and Hospitals
Randal G Ross, MD study director
University of Colorado School of Medicine
Ann Olincy, MD study director
University of Colorado School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phosphatidylcholine, Betaine (588 mg qam and 412 mg qpm) and Betaine (1000 mg BID) in people with Healthy, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in serum choline (time frame: 4 hours post supplement.- baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.