Choline for Menopause

Overseen By Jenna Makarewicz, B.S.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Julie Dumas

Must not be taking: Hormone therapy, SSRIs, SERMS, others

Disqualifiers: MCI, Dementia, Cancer, others

Compensation: Varies

Number of Visits: 3

Duration: 3 study days

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different doses of choline, a nutrient, to observe its effects on brain activity in postmenopausal women. Researchers aim to determine if smaller doses, such as 550 mg and 1100 mg, produce similar brain patterns to a larger 1650 mg dose. The study tracks changes in brain activity using fMRI scans. Women who haven't had a period in over a year and aren’t taking hormone-related medications may be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to contribute to understanding how choline affects brain health in postmenopausal women.

Will I have to stop taking my current medications?

The trial requires that participants are not taking hormone therapy, SSRIs (a type of antidepressant), phytoestrogens, SERMS (selective estrogen receptor modulators), or antiestrogen medications, and they must be at least one year without such treatment. If you are on any of these medications, you would need to stop taking them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that choline is generally safe for use. As an important nutrient, most people tolerate it well in various amounts. Studies suggest that insufficient choline might lead to liver problems, indicating its role in maintaining liver health.

In previous studies, a lack of choline caused organ problems in many postmenopausal women. However, these issues were less common when they received adequate choline. The doses used in the current trial—550 mg and 1100 mg—have been studied before and are likely safe for most people.

Overall, while specific side effects of these doses are not detailed, research supports choline's safety for most people when taken in recommended amounts. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard menopause treatments like hormone replacement therapy and non-hormonal medications, choline is a natural nutrient that plays a crucial role in brain health. Researchers are excited about choline because it may offer cognitive benefits without the side effects associated with hormonal treatments. Choline is believed to support neurotransmitter function, which could improve memory and attention in menopausal women. By exploring both low and higher doses, researchers hope to determine the optimal amount needed to provide these benefits effectively.

What evidence suggests that choline might be an effective treatment for menopause?

Research has shown that choline may support brain health, particularly in postmenopausal women. One study found that 80% of postmenopausal women with insufficient choline intake developed health issues like fatty liver or muscle damage, indicating choline's role in preventing these problems. Another study found that women with higher choline intake had better bone health after menopause. While scientists continue to study how choline affects brain connections, these early findings suggest it could be beneficial during menopause. This trial will compare the effects of low and high doses of choline, as well as a placebo, to further investigate its potential benefits. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for postmenopausal women who are interested in participating in a study to understand the effects of choline on brain signals. Specific eligibility criteria details were not provided, so participants should inquire further about any additional requirements.

Inclusion Criteria

Nonsmokers

Physically healthy

IQ in the normal range > 80

Exclusion Criteria

Blood pressure > 160/100 (untreated)

MCI or dementia - Montreal Cognitive Assessment < 26, Mattis Dementia Rating Scale < 130, and Global Deterioration Scale > 2

I have epilepsy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 550 mg or 1100 mg of oral choline or placebo, with fMRI scans conducted to measure brain activation and connectivity patterns

3 study days

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Choline

Trial Overview The study is testing two different doses of oral choline (550 mg and 1100 mg) against a placebo to see if there's a detectable change in brain activity using fMRI, similar to what was observed with a higher dose of 1650 mg.

How Is the Trial Designed?

Group I: Choline low 550 mg dose Experimental Treatment 1 Intervention

Each subject completes three study days with a low and higher dose of choline and placebo

Group II: Choline higher 1100 mg dose Experimental Treatment 1 Intervention

Each subject completes three study days with a low and higher dose of choline and placebo

Group III: Placebo Placebo Group 1 Intervention

Each subject completes three study days with a low and higher dose of choline and placebo

Who Is Running the Clinical Trial?

Julie Dumas

Lead Sponsor

Published Research Related to This Trial

Menopausal hormone therapy (MHT) is shown to be safe and effective for treating vasomotor symptoms in women under 60 years old and within 10 years of menopause, provided they do not have significant cardiometabolic issues.

Both hormonal and non-hormonal treatment options are available for menopausal symptoms, and the choice of therapy should be tailored to individual risk profiles and treatment goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Hormone and Non-Hormonal Therapy Options for the Treatment of Menopause. Madsen, TE., Sobel, T., Negash, S., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2954445/

Dietary choline requirements of women: effects of estrogen ... Among postmenopausal women, 73% who received placebo but only 18% who received estrogen developed organ dysfunction during the low-choline diet. Conclusions: ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06924541

Choline Dose Ranging 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.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523280648

Sex and menopausal status influence human dietary ... Results: When deprived of dietary choline, 77% of men and 80% of postmenopausal women developed fatty liver or muscle damage, whereas only 44% of premenopausal ...

4. journals.lww.com journals.lww.com/menopausejournal/fulltext/2024/10000/dietary_choline_and_betaine_intake_minimally.3.aspx

Dietary choline and betaine intake minimally impacts rate... Dietary choline and betaine intake minimally impacts rate of annualized cognitive performance throughout the menopause transition.

5. nature.com nature.com/articles/s41598-025-08891-6

Association between total dietary choline intake and ... This study demonstrates for the first time the positive association of dietary choline with BMD in postmenopausal women.

6. ods.od.nih.gov ods.od.nih.gov/factsheets/Choline-HealthProfessional/

Choline - Health Professional Fact Sheet Choline overview for health professionals. Research health effects, dosing, sources, deficiency symptoms, side effects, and interactions ...

7. mcgill.ca mcgill.ca/oss/article/medical-student-contributors/ups-and-downs-choline-supplements

The Ups and Downs of Choline Supplements Another study revealed that 77% of men and 80% of postmenopausal women developed organ dysfunction under choline deprivation, while less than ...