Nutrition as a modifiable causal factor in anti-social behaviours
ISRCTN | ISRCTN41104834 |
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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
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
Study design | Randomised placebo-controlled double-blind trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Other |
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 | 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 | 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 study start date | 01/02/2009 |
Completion date | 31/12/2012 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Male |
Target number of participants | 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
- England
- United Kingdom
Study participating centre
OX1 3PT
United Kingdom
Sponsor information
University/education
Wellington Square
Oxford
OX1 3XP
England
United Kingdom
Phone | +44 (0)1865 270011 |
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richard.lewicki@admin.ox.ac.uk | |
Website | http://www.ox.ac.uk/ |
https://ror.org/052gg0110 |
Funders
Funder type
Charity
Private sector organisation / International organizations
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Available on request |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Editorial Notes
03/05/2016: No publications found, verifying study status with principal investigator.