Choline Dose Ranging in Postmenopausal Women

Description

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.

Conditions

Menopause

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Study Overview

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Study Details

Study overview

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.

Choline Dose Ranging and Brain Functioning in Postmenopausal Women

Choline Dose Ranging in Postmenopausal Women

Condition
Menopause
Intervention / Treatment

-

Contacts and Locations

Burlington

University of Vermont, Burlington, Vermont, United States, 05405

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

50 Years to 65 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Julie Dumas,

Study Record Dates

2025-08-01