RecruitingNot ApplicableNCT06924541

Choline Dose Ranging in Postmenopausal Women

Choline Dose Ranging and Brain Functioning in Postmenopausal Women

Sponsor

Julie Dumas

Enrollment

20 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Menopause

Summary

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.

Eligibility

Sex: FEMALEMin Age: 50 YearsMax Age: 65 Years

Inclusion Criteria8

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 Criteria10

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)