The Associations Between Dietary Choline, Genetics and Anxiety/Depression

Depression Clinical Trial

Official title:

The Association Between Dietary Choline, Genetics and Anxiety/Depression

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04036552
• Other study ID #: SMEC_2018-19_028
• Status: Not yet recruiting
• Start date: August 1, 2019
• Est. completion date: October 3, 2019

Study information

• Verified date: July 2019
• Source: St Mary's University College
• Contact: Leta Pilic, PhD
• Phone: 0208 240 4000
• Email: leta.pilic[@]stmarys.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The associations between dietary choline, genetics and anxiety/depression

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: October 3, 2019
• Est. primary completion date: October 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Choline Deficiency
• Depression
• Depressive Disorder

Locations

Country	Name	City	State
United Kingdom	St Mary's University	London

Sponsors (1)

Lead Sponsor	Collaborator
St Mary's University College

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression	Hospital Anxiety and Depression questionnaire score higher than 11	1 day observation
Primary	Anxiety	Hospital Anxiety and Depression questionnaire score higher than 11	1 day observation
Secondary	Choline intake	Dietary choline intake	3 day observation
Secondary	Plasma choline levels	Choline levels in plasma obtained by colorimetry	1 measurement