Choline DeficiencyNCT04036552
The Associations Between Dietary Choline, Genetics and Anxiety/Depression
An observational study of Choline Deficiency and Anxiety, run by St Mary's University College at 1 site in United Kingdom.
Trial summary
The associations between dietary choline, genetics and anxiety/depression Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Choline Deficiency, Anxiety, Depression
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2019to 3 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- Overall healthy males
- pre-menopausal females of 18-50 years of age.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Association Between Dietary Choline, Genetics and Anxiety/Depression
The associations between dietary choline, genetics and anxiety/depression
Read the 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
- Conditions
- Choline Deficiency, Anxiety, Depression
- Medical subject headings
- Choline Deficiency, Anxiety Disorders, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Hospital Anxiety and Depression questionnaire score higher than 11
Measured: 1 day observation
Anxiety
Hospital Anxiety and Depression questionnaire score higher than 11
Measured: 1 day observation
Secondary outcomes (2)
Choline intake
Dietary choline intake
Measured: 3 day observation
Plasma choline levels
Choline levels in plasma obtained by colorimetry
Measured: 1 measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start1 Aug 2019 (estimated)
- Primary completion3 Oct 2019 (estimated)
- Study completion3 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choline DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Mary's University College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036552
- Sponsor's protocol ID
- SMEC_2018-19_028
- Status last verified
- Jul 2019
- First submitted
- 28 Mar 2019
- Last updated
- 29 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Dietary Choline, Genetics and Anxiety/Depression
- ClinicalTrials.gov ID
- NCT04036552
- Acronym / sponsor ID
- SMEC_2018-19_028
- Conditions
- Choline Deficiency, Anxiety, Depression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- St Mary's University CollegeUniversity, hospital or other
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 3 Oct 2019 (estimated)
- Study completion
- 3 Oct 2019 (estimated)
- First posted
- 29 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The associations between dietary choline, genetics and anxiety/depression
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (2 listed)
- Overall healthy males
- pre-menopausal females of 18-50 years of age.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Depression
Time frame: 1 day observation
Hospital Anxiety and Depression questionnaire score higher than 11
Anxiety
Time frame: 1 day observation
Hospital Anxiety and Depression questionnaire score higher than 11
2 secondary outcomes
Choline intake
Time frame: 3 day observation
Plasma choline levels
Time frame: 1 measurement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Choline Deficiency and Anxiety, run by St Mary's University College at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leta Pilic, PhD (0208 240 4000, leta.pilic@stmarys.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: 1 day observation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2019.