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

Trial Summary

What is the purpose of this trial?

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.

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.

How does the drug Choline differ from other menopause treatments?

Choline is unique for menopause treatment as it is not a hormone-based therapy like traditional options such as hormone replacement therapy (HRT). While HRT involves estrogen and progestin to manage symptoms, Choline may offer a non-hormonal alternative, potentially reducing risks associated with hormone use. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Hormone replacement therapy in the menopause. [2005]

2. England pubmed.ncbi.nlm.nih.gov

[The place of androgen therapy in menopausal women]. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

The use of androgens in menopause. [2019]

4. England pubmed.ncbi.nlm.nih.gov

The menopause: preparing women for what to expect. [2007]

5. New Zealand pubmed.ncbi.nlm.nih.gov

A Review of Hormone and Non-Hormonal Therapy Options for the Treatment of Menopause. [2023]