Examining choline doses in postmenopausal women
Choline Dose Ranging and Brain Functioning in Postmenopausal Women
This study is testing whether smaller doses of choline can help improve brain function in postmenopausal women, compared to a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 50 Years to 65 Years |
| Sex | Female |
| Sponsor | University of Vermont Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Burlington, Vermont) |
| Trial ID | NCT06924541 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of smaller doses of choline (550 mg and 1100 mg) on brain activation and connectivity in postmenopausal women, using a randomized placebo-controlled design. It aims to determine if these lower doses can produce similar cognitive benefits as a previously studied higher dose of 1650 mg. The research focuses on understanding the neurobiological impacts of menopause on cognition and how choline supplementation may influence cognitive functioning. Participants will undergo fMRI scans to assess brain activity in response to the choline doses compared to a placebo.
Who should consider this trial
Good fit: Ideal candidates are healthy postmenopausal women aged 50-65 who are not on hormone therapy or certain medications.
Not a fit: Patients with mild cognitive impairment, dementia, or significant cardiovascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into cognitive enhancement strategies for postmenopausal women.
How similar studies have performed: While some studies have explored the cognitive effects of choline, this specific dose-ranging approach in postmenopausal women is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Burlington, Vermont
- University of Vermont — Burlington, Vermont, United States (Recruiting)
Study contacts
- Study coordinator: Julie Dumas, Ph.D.
- Email: julie.dumas@uvm.edu
- Phone: 8028472523
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.