Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
GR078667MA
Study information
Scientific title
Nutrition as a modifiable causal factor in anti-social behaviours: a randomised, placebo controlled, double blind trial
Acronym
PINUP (PrIson NUtrition Project)
Study hypothesis
Supplements of vitamins, minerals and essential fatty acids will reduce anti-social behaviour in young offenders in prison.
Ethics approval
South East Research Ethics Committee, 11/09/2006, ref: 06/MREC01/47
Study design
Randomised placebo-controlled double-blind trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Vitamin, mineral and essential fatty acid supplementation
Primary outcome measure
Governor's reports (of violence and other offences), measured after 4 months treatment.
Secondary outcome measures
1. 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 trial start date
01/02/2009
Overall trial end date
31/12/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
16 - 21 year old male offenders in prison
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
1000
Participant exclusion criteria
1. Chronic medical conditions
2. Psychotropic medication
Recruitment start date
01/02/2009
Recruitment end date
31/12/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Oxford
Oxford
OX1 3PT
United Kingdom
Sponsor information
Organisation
University of Oxford (UK)
Sponsor details
Wellington Square
Oxford
OX1 3XP
United Kingdom
+44 (0)1865 270011
richard.lewicki@admin.ox.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Wellcome Trust (grant ref: 078667)
Alternative name(s)
Wellcome
Funding Body Type
private sector organisation
Funding Body Subtype
international
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list