The Associations Between Dietary Choline, Genetics and Anxiety/Depression

NCT ID: NCT04036552

Last Updated: 2019-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-01

Study Completion Date

2019-10-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The associations between dietary choline, genetics and anxiety/depression

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Choline, previously considered to be a vitamin, is an essential nutrient involved in a plethora of biological pathways. Choline status is thought to be associated with depression and anxiety, however, the lack of evidence regarding the exact mechanism of its action warrants further investigation. This study aims to explore the associations between dietary choline and depression and anxiety in healthy individuals and how these may differ according to genetics, specifically Phosphatidylethanolamine N-Methyltransferase gene involved in endogenous and exogenous choline metabolism. Establishing these associations could reinforce the need for future intervention trials that could in turn establish causality and determine the mechanistic effects of dietary choline and the PEMT gene activity on depression/anxiety

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Choline Deficiency Anxiety Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Overall healthy males
* pre-menopausal females of 18-50 years of age.

Exclusion Criteria

* Individuals with a current clinical diagnosis of anxiety and depression
* pregnant or lactating
* post-menopausal women
* individuals suffering with chronic disease (cardiovascular disease, type-2 diabetes mellitus and cancer)
* individuals using choline, lecithin or soy supplements,
* obese individuals with a Body Mass Index (BMI) \>30 kg/m2.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

St Mary's University College

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

St Mary's University

London, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Leta Pilic, PhD

Role: CONTACT

0208 240 4000

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SMEC_2018-19_028

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Long Term Chamomile Therapy for Anxiety
NCT01072344 COMPLETED PHASE3