MenopauseNCT06924541
Choline Dose Ranging in Postmenopausal Women
A study testing Choline in people with Menopause, run by Julie Dumas at 1 site in United States.
Trial summary
This study will use a randomized placebo-controlled trial to examine smaller doses of choline and whether a signal in the brain is detectable using fMRI. This study will examine if an even smaller doses of choline can show these similar brain activation and connectivity patterns to the 1650 mg dose. 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
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to 1 Mar 2026
- 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 10Show 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
Official title: Choline Dose Ranging and Brain Functioning in Postmenopausal Women
This study will use a randomized placebo-controlled trial to examine smaller doses of choline and whether a signal in the brain is detectable using fMRI. This study will examine if an even smaller doses of choline can show these similar brain activation and connectivity patterns to the 1650 mg dose. This will be a dose ranging study of 550 mg and 1100 mg oral choline compared to placebo.
Read the detailed description
The brain is a major target for circulating gonadal steroids and the change in hormone levels after menopause is likely to have implications for cognitive functioning. Clinical and preclinical studies have linked gonadal steroids and cognition and it has been hypothesized that menopause has detrimental effects on cognition that are over and above the expected effects of normal aging. However, evidence for changes in cognition after menopause is equivocal. Some studies found decreased cognitive performance after menopause in domains such as memory, attention, problem solving, and motor skills. Other studies have not found changes in cognition after menopause. Additionally, not all women experience negative effects of menopause on cognition. The neurobiological processes underlying individual differences in cognition after menopause are not fully understood.
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.
The investigators recently completed a study of one oral dose of 1650 mg choline versus placebo in 20 healthy postmenopausal women aged 50-65 years. Choline or placebo was administered three hours before an MRI session where subjects underwent an MRS scan as well as functional MRI scans. The MRS scans did not show differences in choline levels in the brain between the choline and placebo study days. However, the functional MRI (fMRI) results showed that choline modulated activation patterns during working memory task as well as influenced functional connectivity between memory relevant regions in the brain. The pattern of activation showed that during the choline challenge compared to placebo, there was decreased frontal activation and increased posterior activation during working memory. The functional connectivity analysis showed decreased connectivity during choline compared to placebo. This pattern of activation is similar to what has been shown with estradiol administration in healthy postmenopausal women. Recent choline data and prior estrogen data resulted in brain activation patterns similar to those of younger adults when compared to older adults. These results were interpreted to indicate that choline in a similar way to estradiol resulted in more efficient patterns of brain activation in healthy postmenopausal women.
This study will use a randomized placebo-controlled trial to examine smaller doses of choline and to detect a signal in the brain using fMRI. This study will examine if even smaller doses of choline can show these similar brain activation and connectivity patterns to the 1650 mg dose. This is a dose ranging study of 550 mg and 1100 mg oral choline compared to placebo.
- Conditions
- Menopause
- Being tested
- Choline, Placebo
- Keywords
- cognition, fMRI, working memory
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 of two oral choline doses or placebo on each of three study days, 550 mg, 1100 mg, and placebo
PlaceboDietary supplement
Each subject gets one of two oral choline doses or placebo on each of three study days, 550 mg, 1100 mg, and placebo
| Study group | Role | What they receive |
|---|---|---|
| Choline low 550 mg dose | Experimental | Each subject completes three study days with a low and higher dose of choline and placebo Receives: Dietary Supplement: Choline |
| Choline higher 1100 mg dose | Experimental | Each subject completes three study days with a low and higher dose of choline and placebo Receives: Dietary Supplement: Choline |
| Placebo | Placebo comparator | Each subject completes three study days with a low and higher dose of 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 three study days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start1 Sep 2024
- Primary completion1 Dec 2025
- Study completion1 Mar 2026
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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Julie Dumas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Julie Dumas, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924541
- Sponsor's protocol ID
- STU3122
- Status last verified
- Oct 2026
- First submitted
- 19 Aug 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choline Dose Ranging and Brain Functioning in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT06924541
- Acronym / sponsor ID
- STU3122
- Conditions
- Menopause
- Keywords
- cognition, fMRI, working memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Julie DumasUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 11 Apr 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 smaller doses of choline and whether a signal in the brain is detectable using fMRI. This study will examine if an even smaller doses of choline can show these similar brain activation and connectivity patterns to the 1650 mg dose. This will be a dose ranging study of 550 mg and 1100 mg oral choline compared to placebo.
Detailed description
The brain is a major target for circulating gonadal steroids and the change in hormone levels after menopause is likely to have implications for cognitive functioning. Clinical and preclinical studies have linked gonadal steroids and cognition and it has been hypothesized that menopause has detrimental effects on cognition that are over and above the expected effects of normal aging. However, evidence for changes in cognition after menopause is equivocal. Some studies found decreased cognitive performance after menopause in domains such as memory, attention, problem solving, and motor skills. Other studies have not found changes in cognition after menopause. Additionally, not all women experience negative effects of menopause on cognition. The neurobiological processes underlying individual differences in cognition after menopause are not fully understood.
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.
The investigators recently completed a study of one oral dose of 1650 mg choline versus placebo in 20 healthy postmenopausal women aged 50-65 years. Choline or placebo was administered three hours before an MRI session where subjects underwent an MRS scan as well as functional MRI scans. The MRS scans did not show differences in choline levels in the brain between the choline and placebo study days. However, the functional MRI (fMRI) results showed that choline modulated activation patterns during working memory task as well as influenced functional connectivity between memory relevant regions in the brain. The pattern of activation showed that during the choline challenge compared to placebo, there was decreased frontal activation and increased posterior activation during working memory. The functional connectivity analysis showed decreased connectivity during choline compared to placebo. This pattern of activation is similar to what has been shown with estradiol administration in healthy postmenopausal women. Recent choline data and prior estrogen data resulted in brain activation patterns similar to those of younger adults when compared to older adults. These results were interpreted to indicate that choline in a similar way to estradiol resulted in more efficient patterns of brain activation in healthy postmenopausal women.
This study will use a randomized placebo-controlled trial to examine smaller doses of choline and to detect a signal in the brain using fMRI. This study will examine if even smaller doses of choline can show these similar brain activation and connectivity patterns to the 1650 mg dose. This is a dose ranging study of 550 mg and 1100 mg oral choline compared to placebo.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Placebo controlled study
| Arm | Type | Receives |
|---|---|---|
| Choline low 550 mg dose | Experimental | Dietary Supplement: CholineEach subject completes three study days with a low and higher dose of choline and placebo |
| Choline higher 1100 mg dose | Experimental | Dietary Supplement: CholineEach subject completes three study days with a low and higher dose of choline and placebo |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboEach subject completes three study days with a low and higher dose of 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 (10 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 of two oral choline doses or placebo on each of three study days, 550 mg, 1100 mg, and placebo | Dietary supplement | Choline higher 1100 mg dose, Choline low 550 mg dose |
| PlaceboEach subject gets one of two oral choline doses or placebo on each of three study days, 550 mg, 1100 mg, and placebo | Dietary supplement | Placebo |
Primary outcome
BOLD Signal during fMRI working memory task
Time frame: measured on each of the three 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 2 Nov 2026.
- Individual participant dataSharing planned: Undecided. 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Julie Dumas 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 10 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 Nov 2026. 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. Some participants in this study may receive a placebo. 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 three 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 2 Nov 2026.