Nutrition as a modifiable causal factor in anti-social behaviours
| ISRCTN | ISRCTN41104834 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41104834 |
| Protocol serial number | GR078667MA |
| Sponsor | University of Oxford (UK) |
| Funder | Wellcome Trust (grant ref: 078667) |
- Submission date
- 05/01/2009
- Registration date
- 06/01/2009
- Last edited
- 13/05/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
We have previously shown that better nutrition reduced offending in a prison and poor nutrition may thus be a cause of antisocial behaviour that we can do something about. This raises the possibility that for a great number of people, not only their health but also their ability to behave sociably could be improved by changing what they eat. This is not an area currently considered in standards of dietary adequacy and little is currently known about the best nutrient dosages required for brain function or behaviour. We will therefore carry out a larger study in 3 Young Offenders Institutes; we will administer vitamin, mineral and essential fatty acid supplements or placebo capsules to confirm our previous results and try to match the prisoners blood level changes in these nutrients with a range of behavioural measures.
Who can participate?
Volunteers from three institutions housing 1200 finally sentenced male prisoners aged 16 to 21 years.
What does the study involve?
Volunteers will take capsules containing vitamins, mineral and essential fatty acids or dummy (placebo) capsules. Volunteers will be randomly allocated to receive either the active capsule or placebo, and neither the volunteer nor the person giving them the capsule will know which one they are getting. Blood samples will be collected before and during supplementation to allow us to assess how changes in nutrient levels affect a range of behaviours including: violence, drug-related offences and incidents of self-harm. We will also match changes in blood levels with measures of attention, planning skills, impulse control and social interactions.
What are the possible benefits and risks of participating?
Improving nutrition should improve the health of the prisoners taking the active supplements. Since these are normal nutrients, adverse effects are highly unlikely. Those who dislike having blood taken will be free to decline.
Where is the study run from?
Department of Physiology, Anatomy and Genetics at Oxford University (UK)
When is the study starting and how long is it expected to run for?
The study started in March 2009 and is expected to run for 4 years.
Who is funding the study?
The Wellcome Trust (UK)
Who is the main contact?
Professor John F Stein
john.stein@dpag.ox.ac.uk
Contact information
Scientific
Physiology, Anatomy and Genetics
Parks Road
Oxford
OX1 3PT
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised placebo-controlled double-blind trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Nutrition as a modifiable causal factor in anti-social behaviours: a randomised, placebo controlled, double blind trial |
| Study acronym | PINUP (PrIson NUtrition Project) |
| Study objectives | Supplements of vitamins, minerals and essential fatty acids will reduce anti-social behaviour in young offenders in prison. |
| Ethics approval(s) | South East Research Ethics Committee, 11/09/2006, ref: 06/MREC01/47 |
| Health condition(s) or problem(s) studied | Anti-social behaviour in prison |
| Intervention | Food supplements (minerals, vitamins and essential fatty acids): 1. Forceval (Alliance Pharma plc): contains vitamin A (750 µg), vitamin D (10 µg), vitamin B1 (1.2 mg), vitamin B2 (1.6 mg), vitamin B6 (2 mg), vitamin B12 (3 µg), vitamin C (60 mg), vitamin E (10 mg), vitamin K1 (120 µg), biotin (100 µg), nicotinamide (18 mg), pantothenic acid (4 mg), folic acid (400 µg), calcium (100 mg), iron (12 mg), copper (2 mg), magnesium (30 mg), zinc (18 mg), iodine (140 µg), manganese (3 mg), potassium (4 mg), phosphorus (77 mg), selenium (50 µg), chromium (200 µg), molybdenum (250 µg). 1 capsule per day p.o. (by mouth). 2. Equazen: contains gamma linolenic acid (45 mg), eicosapentaenoic acid (EPA) (951 mg), docosahexaenoic acid (DHA) (147 mg), vitamin E (8.4 mg), magnesium (60 mg). 3 x 854 mg capsules daily by mouth. Total duration of treatment: 4 months (maximum) Total duration of follow-up: 1 month (for all treatment arms) |
| Intervention type | Supplement |
| Primary outcome measure(s) |
Governor's reports (of violence and other offences), measured after 4 months treatment. |
| Key secondary outcome measure(s) |
1. Blood levels of micronutrients, measured after 4 months treatment |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 1000 |
| Key inclusion criteria | 16 - 21 year old male offenders in prison |
| Key exclusion criteria | 1. Chronic medical conditions 2. Psychotropic medication |
| Date of first enrolment | 01/02/2009 |
| Date of final enrolment | 31/12/2012 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
OX1 3PT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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 |
Editorial Notes
03/05/2016: No publications found, verifying study status with principal investigator.
