MenopauseNCT07264257
Choline and Brain Functioning in Postmenopausal Women
A study testing Choline in people with Menopause, run by University of Vermont at 1 site in United States.
Trial summary
This study will use a randomized placebo-controlled trial to examine a single oral dose of 1650 mg choline influences brain functioning as measured by fMRI. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- Choline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2022to 1 Mar 2025
- 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 50 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged 50-65 years
- Postmenopausal: Women who are postmenopausal will have not had a period in the last 12 months, have FSH>30 IU/L, and estradiol (E2) <50 pg/ml.
- Nonsmokers
- Not taking hormone therapy, SSRIs, phytoestrogens, SERMS, or antiestrogen medications and will be at least one year without such treatment
- Physically healthy
- No cardiovascular disease other than mild hypertension. Subjects will also not have current untreated or unremitted Axis I or II psychiatric or cognitive disorders (see screening below).
- IQ in the normal range >80
- Normal neuropsychological test performance
Who cannot join
- MCI or dementia - Montreal Cognitive Assessment <26, Mattis Dementia Rating Scale <130, and Global Deterioration Scale >2
- History of cancer treatment with cytotoxic and/or ongoing (current) maintenance targeted chemotherapy
- Blood pressure > 160/100 (untreated)
- Untreated thyroid disease
- Significant cardiovascular disease
- Asthma or COPD
Show all 11Show fewer
- Active peptic ulcer
- Hyperthyroidism
- Epilepsy
- Current untreated or unremitted Axis I psychiatric disorders
- Use of medications on the Prohibited medications (see list)
Trial locations and contacts
1 site in 1 country.
About this study
This study will use a randomized placebo-controlled trial to examine a single oral dose of 1650 mg choline influences brain functioning as measured by fMRI.
Read the detailed description
Choline is an essential nutrient that, in addition to its role in the brain, has a number of critical structural and physiologic roles throughout the body, including providing structural integrity and signaling function for cell membranes, facilitating lipid transport from the liver, and acting as the major source of methyl groups through diet. Aside from dietary intake, the only source of choline in the body is de novo synthesis of phosphatidylcholine, catalyzed by phosphatdylethanolamine-N-methyltransferase (PEMT). The PEMT gene has several estrogen-responsive components in its promoter region and is induced by estrogen. Post-menopausal (hypo-estrogenic) women with loss of function mutations in PEMT have been found to exhibit end-organ damage typical of choline deficiency.
Choline is also involved in the synthesis of acetylcholine, a major neurotransmitter and the central and peripheral nervous systems. The relationship between brain effects of the normal functioning of the cholinergic system and hormone changes after menopause has been demonstrated in preclinical studies in rat models and in experimentally in human studies. While the preclinical and clinical experiment studies have many similar findings regarding the influence of estrogen on cholinergic functioning, what is not clear from this research is how individual differences arise in the effects of the hormone withdrawal after menopause on brain functioning in middle aged women. It is possible that the estrogen control of the transcription of the PEMT gene may influence the availability of choline.
This study will examine the effects of a single oral dose of oral dose of 1650 mg choline versus placebo in 20 healthy postmenopausal women aged 50-65 years. Choline or placebo will be administered three hours before an MRI session where subjects undergo functional MRI scans.
- Conditions
- Menopause
- Being tested
- Choline, Placebo
- Keywords
- cognition, fMRI, working memory, choline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholineDietary supplement
Each subject gets one 1650 mg oral choline dose or placebo on each of two study days.
PlaceboDietary supplement
Each subject gets one 1650 mg oral choline dose or placebo on each of two study days.
| Study group | Role | What they receive |
|---|---|---|
| Choline | Experimental | Each subject completes two study days with choline and placebo. Receives: Dietary Supplement: Choline |
| Placebo | Experimental | Each subject completes two study days with choline and placebo. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD Signal during fMRI working memory task
fMRI BOLD signal during a working memory task
Measured: Measured on each of the two study days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start15 Jun 2022
- Primary completion20 Dec 2022
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- placebo controlled study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- Balchem Corporation
- Responsible party
- Principal investigator, Julie Dumas, University of Vermont
- Investigators
- Julie A Dumas, PhD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264257
- Sponsor's protocol ID
- STU1720
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After data are published, deidentified data will be made available to those who request access.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choline and Brain Functioning in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT07264257
- Acronym / sponsor ID
- STU1720
- Conditions
- Menopause
- Keywords
- cognition, fMRI, working memory, choline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- Balchem Corporation
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 4 Dec 2025 (actual)
- 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.
This study will use a randomized placebo-controlled trial to examine a single oral dose of 1650 mg choline influences brain functioning as measured by fMRI.
Detailed description
Choline is an essential nutrient that, in addition to its role in the brain, has a number of critical structural and physiologic roles throughout the body, including providing structural integrity and signaling function for cell membranes, facilitating lipid transport from the liver, and acting as the major source of methyl groups through diet. Aside from dietary intake, the only source of choline in the body is de novo synthesis of phosphatidylcholine, catalyzed by phosphatdylethanolamine-N-methyltransferase (PEMT). The PEMT gene has several estrogen-responsive components in its promoter region and is induced by estrogen. Post-menopausal (hypo-estrogenic) women with loss of function mutations in PEMT have been found to exhibit end-organ damage typical of choline deficiency.
Choline is also involved in the synthesis of acetylcholine, a major neurotransmitter and the central and peripheral nervous systems. The relationship between brain effects of the normal functioning of the cholinergic system and hormone changes after menopause has been demonstrated in preclinical studies in rat models and in experimentally in human studies. While the preclinical and clinical experiment studies have many similar findings regarding the influence of estrogen on cholinergic functioning, what is not clear from this research is how individual differences arise in the effects of the hormone withdrawal after menopause on brain functioning in middle aged women. It is possible that the estrogen control of the transcription of the PEMT gene may influence the availability of choline.
This study will examine the effects of a single oral dose of oral dose of 1650 mg choline versus placebo in 20 healthy postmenopausal women aged 50-65 years. Choline or placebo will be administered three hours before an MRI session where subjects undergo functional MRI scans.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- placebo controlled study
| Arm | Type | Receives |
|---|---|---|
| Choline | Experimental | Dietary Supplement: CholineEach subject completes two study days with choline and placebo. |
| Placebo | Experimental | Dietary Supplement: PlaceboEach subject completes two study days with choline and placebo. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women aged 50-65 years
- Postmenopausal: Women who are postmenopausal will have not had a period in the last 12 months, have FSH>30 IU/L, and estradiol (E2) <50 pg/ml.
- Nonsmokers
- Not taking hormone therapy, SSRIs, phytoestrogens, SERMS, or antiestrogen medications and will be at least one year without such treatment
- Physically healthy
Key exclusion criteria (11 listed)
- MCI or dementia - Montreal Cognitive Assessment <26, Mattis Dementia Rating Scale <130, and Global Deterioration Scale >2
- History of cancer treatment with cytotoxic and/or ongoing (current) maintenance targeted chemotherapy
- Blood pressure > 160/100 (untreated)
- Untreated thyroid disease
- Significant cardiovascular 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 |
|---|---|---|
| CholineEach subject gets one 1650 mg oral choline dose or placebo on each of two study days. | Dietary supplement | Choline |
| PlaceboEach subject gets one 1650 mg oral choline dose or placebo on each of two study days. | Dietary supplement | Placebo |
Primary outcome
BOLD Signal during fMRI working memory task
Time frame: Measured on each of the two study days
fMRI BOLD signal during a working memory task
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 4 Dec 2025.
- Individual participant dataSharing planned: Yes. After data are published, deidentified data will be made available to those who request access.
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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.
Julie A Dumas, PhD principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Choline in people with Menopause, run by University of Vermont 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 8 inclusion and 11 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 4 Dec 2025. 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?
BOLD Signal during fMRI working memory task (time frame: Measured on each of the two study days). 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 4 Dec 2025.