Choline Dose Ranging in Postmenopausal Women

Completed · Not applicable · Has a placebo group

Conditions studied: Menopause

In brief

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.

Key facts

Study ID

NCT06924541

Run by

Julie Dumas

People needed

20

Starts

2024-09-01

Expected to finish

2026-03-01

Last updated by the study team

2026-05-04

Who can join

Age: 50 and older, up to 65. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Epilepsy
• Current untreated or unremitted Axis I psychiatric disorders Use of medications on the Prohibited medications (see list)

Where it is running

• University of Vermont — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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