The relationship between nutrition, inflammation and depression in pregnancy and following birth
| ISRCTN | ISRCTN02355244 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02355244 |
| Protocol serial number | N/A |
| Sponsor | The Centre for Obesity Research and Epidemiology (CORE) (UK) |
| Funder | The Centre for Obesity Research and Epidemiology (CORE) (UK) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
The Centre for Obesity Research and Epidemiology
The Robert Gordon University
Aberdeen
AB25 1HG
United Kingdom
| Phone | +44 (0)1224 262895 |
|---|---|
| j.broom@rgu.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational prospective (longitudinal) cohort study |
| Secondary study design | Cohort study |
| Study type | Participant 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 objectives | 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) |
| Health condition(s) or problem(s) studied | 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(s) |
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 |
| Key secondary outcome measure(s) |
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) |
| Completion 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 sample size at registration | 100 |
| Key inclusion criteria | 1. Pregnancy and post-partum 2. Age 18 - 45 years 3. Healthy volunteers 4. Patient under Grampian Healthcare |
| Key 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 |
| Date of first enrolment | 03/11/2008 |
| Date of final enrolment | 25/06/2010 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
AB25 1HG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
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
