Choline and Brain Functioning in Postmenopausal Women

NCT07264257 | Completed

• 1 other identifier: STU1720
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This study will use a randomized placebo-controlled trial to examine a single oral dose of 1650 mg choline influences brain functioning as measured by fMRI.

Conditions

Menopause

Keywords

cognition; fMRI; working memory; choline

Outcome Measures

Primary Outcomes (1)

• BOLD Signal during fMRI working memory task

  fMRI BOLD signal during a working memory task

  Measured on each of the two study days

Study Arms (2)

Choline

EXPERIMENTAL

Each subject completes two study days with choline and placebo.

Dietary Supplement: Choline

Placebo

EXPERIMENTAL

Each subject completes two study days with choline and placebo.

Dietary Supplement: Placebo

Interventions

Placebo DIETARY_SUPPLEMENT

Each subject gets one 1650 mg oral choline dose or placebo on each of two study days.

Placebo

Choline DIETARY_SUPPLEMENT

Each subject gets one 1650 mg oral choline dose or placebo on each of two study days.

Choline

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Vermont: lead
• Balchem Corporation: collaborator

Study Sites (1)

University of Vermont

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Interventions

Choline

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Onium Compounds

Study Officials

• Julie A Dumas, PhD

  University of Vermont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: placebo controlled study

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: December 4, 2025
• Study Start: June 15, 2022
• Primary Completion: December 20, 2022
• Study Completion: March 1, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: 10/2025 until 9/2030

Locations

US (1)