Choline and Brain Functioning in Postmenopausal Women

What this trial studies

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.

Conditions in scope

• Menopause

Interventions

• Choline (Dietary Supplement) — Each subject gets one 1650 mg oral choline dose or placebo on each of two study days.
• Placebo (Dietary Supplement) — Each subject gets one 1650 mg oral choline dose or placebo on each of two study days.

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: 2022-06-15
• Primary completion: 2022-12-20
• Last update posted: 2025-12-04
• First posted: 2025-12-04

Sponsor & contact

Lead sponsor: University of Vermont (Other)

Collaborators: Balchem Corporation

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 two 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.