Nutrition as a modifiable causal factor in anti-social behaviours

ISRCTN ISRCTN41104834
DOI https://doi.org/10.1186/ISRCTN41104834
Secondary identifying numbers GR078667MA
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Prof John Stein
Scientific

Physiology, Anatomy and Genetics
Parks Road
Oxford
OX1 3PT
United Kingdom

Study information

Study designRandomised placebo-controlled double-blind trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleNutrition as a modifiable causal factor in anti-social behaviours: a randomised, placebo controlled, double blind trial
Study acronymPINUP (PrIson NUtrition Project)
Study objectivesSupplements 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) studiedAnti-social behaviour in prison
InterventionFood 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 typeSupplement
Primary outcome measureGovernor's reports (of violence and other offences), measured after 4 months treatment.
Secondary outcome measures1. Blood levels of micronutrients, measured after 4 months treatment
2. Cambridge Neuropsychological Test Automated Battery (CANTAB) measures of impulsivity, attention, measured after 4 months treatment
3. Heart rate variability changes, measured after 4 months treatment
Overall study start date01/02/2009
Completion date31/12/2012

Eligibility

Participant type(s)Patient
Age groupAdult
SexMale
Target number of participants1000
Key inclusion criteria16 - 21 year old male offenders in prison
Key exclusion criteria1. Chronic medical conditions
2. Psychotropic medication
Date of first enrolment01/02/2009
Date of final enrolment31/12/2012

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Oxford
Oxford
OX1 3PT
United Kingdom

Sponsor information

University of Oxford (UK)
University/education

Wellington Square
Oxford
OX1 3XP
England
United Kingdom

Phone +44 (0)1865 270011
Email richard.lewicki@admin.ox.ac.uk
Website http://www.ox.ac.uk/
ROR logo "ROR" https://ror.org/052gg0110

Funders

Funder type

Charity

Wellcome Trust (grant ref: 078667)
Private sector organisation / International organizations
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

03/05/2016: No publications found, verifying study status with principal investigator.