The relationship between nutrition, inflammation and depression in pregnancy and following birth

ISRCTN	ISRCTN02355244
DOI	https://doi.org/10.1186/ISRCTN02355244
Secondary identifying numbers	N/A

Submission date: 22/09/2008
Registration date: 30/09/2008
Last edited: 20/08/2020

Recruitment status: No longer recruiting
Overall study status: Stopped
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Study website

Contact information

Prof Iain Broom
Scientific

The Centre for Obesity Research and Epidemiology
The Robert Gordon University
Aberdeen
AB25 1HG
United Kingdom

Phone	+44 (0)1224 262895
Email	j.broom@rgu.ac.uk

Study information

Study design	Observational prospective (longitudinal) cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Not specified
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The relationship between nutrition, increased inflammation and depression in pregnancy and post-partum: assessment of depression scores, inflammatory cytokines and omega-3 fatty acids
Study acronym	DIO-3
Study hypothesis	Psychological stress and depression increase the production of pro-inflammatory cytokines, and reduce the production of anti-inflammatory/immuno-regulatory cytokines. An increased ratio of omega-6 to omega-3 polyunsaturated fatty acids (PUFAs) in the blood causes an increase in the production of pro-inflammatory cytokines and a reduction in the production of anti-inflammatory cytokines. Population studies have found an inverse relationship between depression and per capita fish consumption; and lower blood/plasma omega-3 FA content has been found in subjects with depression. Pregnancy and post-partum are associated with immune activation and hypersecretion of pro-inflammatory cytokines and elevated C-reactive protein. Studies have reported low blood omega-3 FA levels in pregnancy and post-partum. Psychological stress and depression are prevalent in pregnancy. Psycho-social risk factors known to be associated with depression increase the prevalence of depression in pregnancy. A higher omega-6 to omega-3 ratio may predict an increase in the production of pro-inflammatory cytokines to psychological stress and depression. The aim of this study is to investigate the relationship between maternal omega-3 and omega-6 PUFA status (evaluated by the food frequency questionnaire [FFQ] and erythrocyte membrane FA), inflammatory cytokines and depression during pregnancy and post-partum in women at high-risk of depression (a history of psycho-social risk factors associated with perinatal depression) and low-risk of depression; and to assess the potential for the development of specific biomarkers to predict the onset and progression of this condition.
Ethics approval(s)	The North of Scotland Research Ethics Committee, 11th June 2008 (REC Ref: 08/S0801/21)
Condition	Maternal stress and depression
Intervention	This is an observational prospective longitudinal (from first trimester of pregnancy to 6 months post-partum) cohort study, where the data concerning the condition are assembled and observed prior to the condition occurring and when the condition occurs. Patients without depression, but identified as high-risk (psycho-social history of exposure) and low-risk of depression (no psycho-social history of exposure) will be followed and observed for depression, increased inflammation and high omega-6 to omega-3 ratio. The following data will be collected: 1. Assessment of risk factors known to be associated with perinatal depression (Antenatal Risk Questionnaire [ANRQ]; Postnatal Risk Questionnaire [PNRQ]) 2. Assessment of perinatal psychological stress and depression (Edinburgh Depression Scale/Edinburgh Postnatal Depression Scale [EDS/EPDS]; Hospital and Anxiety Depression Scale [HADS]) 3. Assessment of dietary omega-3 and omega-6 FAs (Scottish Collaborative Group Food Frequency Questionnaire [SCGFFQ]) 4. Assessment of erythrocyte membrane omega-3 and omega-6 FA content 5. Assessment of serum inflammatory cytokines 6. Assessment of plasma C-reactive protein
Intervention type	Other
Primary outcome measure	1. Differences in depression scores, inflammatory cytokines and CRP concentrations and omega-3 FA status between women at high-risk (a history of psycho-social risk factors associated with perinatal depression) and low-risk of depression 2. Correlations between omega-6 to omega-3 FA ratio, inflammatory cytokines and CRP concentrations and depression scores Time points: 1. Baseline (13 weeks gestation) 2. 24 weeks gestation 3. 34 weeks gestation 4. 36 hours post-delivery 5. 6 weeks post-partum 6. 12 weeks post-partum 7. 24 weeks post-partum
Secondary outcome measures	1. Incidence of depression in women at high-risk of depression (a history of psycho-social risk factors associated with perinatal depression) and low-risk of depression (measured by the ANRQ and PNRQ) (the ANRQ is used only at baseline; the PNRQ is used only at 36 hours post-delivery) 2. Comparison of depression scores measured by the EDP/EPDS and the HADS 3. Comparison of omega-3 and omega-6 FA intakes measured by the SCGFFQ and erythrocyte membrane content Time points: 1. Baseline (13 weeks gestation) 2. 24 weeks gestation 3. 34 weeks gestation 4. 36 hours post-delivery 5. 6 weeks post-partum 6. 12 weeks post-partum 7. 24 weeks post-partum
Overall study start date	03/11/2008
Overall study end date	25/06/2010
Reason abandoned (if study stopped)	Lack of staff/facilities/resources

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	100
Participant inclusion criteria	1. Pregnancy and post-partum 2. Age 18 - 45 years 3. Healthy volunteers 4. Patient under Grampian Healthcare
Participant exclusion criteria	1. Medical conditions (including obstetric complications) or currently taking medication affecting the immune, endocrine (thyroid dysfunction, diabetes), metabolic, hepatic, renal, and gastrointestinal systems; coagulation disorders and anaemia 2. A history of psychiatric disorders other than depression (mania/hypomania, psychosis, active suicidal ideation, schizophrenia, eating disorders not associated with depression, personality disorders, epilepsy) 3. Taking anti-depressant medication or other remedies for depression (St Johns Wort) 4. A history of alcohol or drug abuse, and tobacco use 5. Assisted conception 6. Taking supplementary fish oils or flax seed 8. Spontaneous miscarriage and termination of pregnancy
Recruitment start date	03/11/2008
Recruitment end date	25/06/2010

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

The Centre for Obesity Research and Epidemiology

Aberdeen
AB25 1HG
United Kingdom

Sponsor information

The Centre for Obesity Research and Epidemiology (CORE) (UK)
Research organisation

The Robert Gordon University
Aberdeen
AB25 1HG
United Kingdom

Phone	+44 (0)1224 262641
Email	j.broom@rgu.ac.uk
Website	http://www.rgu.ac.uk/acero/CORE/
"ROR"	https://ror.org/04f0qj703

Funders

Funder type

Research organisation

The Centre for Obesity Research and Epidemiology (CORE) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

20/08/2020: The overall trial status has been updated to "Stopped".
26/06/2016: No publications found, verifying study status with principal investigator