NCT04036552

Brief Summary

The associations between dietary choline, genetics and anxiety/depression

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 29, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2019

Completed
Last Updated

July 29, 2019

Status Verified

July 1, 2019

Enrollment Period

2 months

First QC Date

March 28, 2019

Last Update Submit

July 26, 2019

Conditions

Choline DeficiencyAnxietyDepression

Outcome Measures

Primary Outcomes (2)

  • Depression

    Hospital Anxiety and Depression questionnaire score higher than 11

    1 day observation

  • Anxiety

    Hospital Anxiety and Depression questionnaire score higher than 11

    1 day observation

Secondary Outcomes (2)

  • Choline intake

    3 day observation

  • Plasma choline levels

    1 measurement

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Mary's University

London, TW14SX, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva and blood

MeSH Terms

Conditions

Choline DeficiencyAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Vitamin B DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesMental DisordersBehavioral SymptomsBehavior

Central Study Contacts

Leta Pilic, PhD

CONTACT

0208 240 4000leta.pilic@stmarys.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2019

First Posted

July 29, 2019

Study Start

August 1, 2019

Primary Completion

October 3, 2019

Study Completion

October 3, 2019

Last Updated

July 29, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)