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The Associations Between Dietary Choline, Genetics and Anxiety/Depression

Sponsor
St Mary's University College (Other)
Overall Status
Unknown status
CT.gov ID
NCT04036552
Collaborator
(none)
80
Enrollment
1
Location
2.1
Anticipated Duration (Months)
38.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The associations between dietary choline, genetics and anxiety/depression

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    The Association Between Dietary Choline, Genetics and Anxiety/Depression
    Anticipated Study Start Date :
    Aug 1, 2019
    Anticipated Primary Completion Date :
    Oct 3, 2019
    Anticipated Study Completion Date :
    Oct 3, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Depression [1 day observation]

      Hospital Anxiety and Depression questionnaire score higher than 11

    2. Anxiety [1 day observation]

      Hospital Anxiety and Depression questionnaire score higher than 11

    Secondary Outcome Measures

    1. Choline intake [3 day observation]

      Dietary choline intake

    2. Plasma choline levels [1 measurement]

      Choline levels in plasma obtained by colorimetry

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St Mary's University London United Kingdom TW14SX

    Sponsors and Collaborators

    • St Mary's University College

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    St Mary's University College
    ClinicalTrials.gov Identifier:
    NCT04036552
    Other Study ID Numbers:
    • SMEC_2018-19_028
    First Posted:
    Jul 29, 2019
    Last Update Posted:
    Jul 29, 2019
    Last Verified:
    Jul 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Choline Deficiency
    Depression
    Depressive Disorder
    Anxiety Disorders

    Study Results

    No Results Posted as of Jul 29, 2019