Choline Dose Ranging in Postmenopausal Women

What this trial studies

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.

Conditions in scope

• Menopause

Interventions

• Choline (Dietary Supplement) — Each subject gets one of two oral choline doses or placebo on each of three study days, 550 mg, 1100 mg, and placebo
• Placebo (Dietary Supplement) — Each subject gets one of two oral choline doses or placebo on each of three study days, 550 mg, 1100 mg, and placebo

Who can join

Women only · Ages 50 Years to 65 Years · Accepts healthy volunteers.

Inclusion criteria

• 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

Exclusion criteria

• 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
• Active peptic ulcer
• Hyperthyroidism

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: N/A
• Start date: 2024-09-01
• Primary completion: 2025-12-01
• Last update posted: 2026-05-04
• First posted: 2025-04-11

Sponsor & contact

Lead sponsor: Julie Dumas (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• BOLD Signal during fMRI working memory task (measured on each of the three study days)
  fMRI BOLD signal during a working memory task

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.