Choline Dose Ranging in Postmenopausal Women

Launched by JULIE DUMAS · Apr 4, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how different doses of choline, a nutrient found in some foods, affect brain activity in postmenopausal women. Researchers want to see if smaller doses of choline (550 mg and 1100 mg) can produce similar effects in the brain as a larger dose (1650 mg) that has already been studied. Participants will be given either the choline or a placebo (a substance with no active ingredients) to compare results using brain scans.

To participate, women must be aged 50 to 65 and postmenopausal, meaning they haven't had a period for at least a year. They should also be healthy, not taking certain medications, and must meet specific health criteria. If eligible, participants can expect to take a daily dose of choline or a placebo for a set period and undergo brain scans to measure any changes. This study aims to understand how choline might help with brain function during menopause, which could lead to new insights in women’s health.

Gender

FEMALE

Eligibility criteria

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