The Associations Between Dietary Choline, Genetics and Anxiety/Depression

July 26, 2019 updated by: St Mary's University College

The Association Between Dietary Choline, Genetics and Anxiety/Depression

The associations between dietary choline, genetics and anxiety/depression

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

To be able to detect an association between choline and depression/anxiety required number of participants is 40. However, to reach the adequate balance between groups of people that have the PEMT genetic variant and the ones that do not have it, 80 will be recruited. This is because the PEMT variant of interest is present in 50% of the population

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression
Time Frame: 1 day observation
Hospital Anxiety and Depression questionnaire score higher than 11
1 day observation
Anxiety
Time Frame: 1 day observation
Hospital Anxiety and Depression questionnaire score higher than 11
1 day observation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Choline intake
Time Frame: 3 day observation
Dietary choline intake
3 day observation
Plasma choline levels
Time Frame: 1 measurement
Choline levels in plasma obtained by colorimetry
1 measurement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St Mary's University College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2019

Primary Completion (Anticipated)

October 3, 2019

Study Completion (Anticipated)

October 3, 2019

Study Registration Dates

First Submitted

March 28, 2019

First Submitted That Met QC Criteria

July 26, 2019

First Posted (Actual)

July 29, 2019

Study Record Updates

Last Update Posted (Actual)

July 29, 2019

Last Update Submitted That Met QC Criteria

July 26, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMEC_2018-19_028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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