Choline Dose Ranging in Postmenopausal Women

NCT06924541 | Completed

• 1 other identifier: STU3122
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Menopause

Keywords

cognition; fMRI; working memory

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 three study days

Study Arms (3)

Choline low 550 mg dose

EXPERIMENTAL

Each subject completes three study days with a low and higher dose of choline and placebo

Dietary Supplement: Choline

Choline higher 1100 mg dose

EXPERIMENTAL

Each subject completes three study days with a low and higher dose of choline and placebo

Dietary Supplement: Choline

Placebo

PLACEBO COMPARATOR

Each subject completes three study days with a low and higher dose of choline and placebo

Dietary Supplement: Placebo

Interventions

Choline DIETARY_SUPPLEMENT

Each subject gets one of two oral choline doses or placebo on each of three study days, 550 mg, 1100 mg, and placebo

Choline higher 1100 mg dose; Choline low 550 mg dose

Placebo DIETARY_SUPPLEMENT

Each subject gets one of two oral choline doses or placebo on each of three study days, 550 mg, 1100 mg, and placebo

Placebo

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

• Julie Dumas: lead

Study Sites (1)

University of Vermont

Burlington, Vermont, 05405, 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 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: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Placebo controlled study

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: April 11, 2025
• Study Start: September 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (1)