Choline Dose Ranging in Postmenopausal Women (NCT06924541) | Clinical Trial Compass
CompletedNot Applicable
Choline Dose Ranging in Postmenopausal Women
United States20 participantsStarted 2024-09-01
Plain-language 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.
Who can participate
Age range50 Years – 65 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
What they're measuring
1
BOLD Signal during fMRI working memory task
Timeframe: measured on each of the three study days