Condition category
Mental and Behavioural Disorders
Date applied
05/01/2009
Date assigned
06/01/2009
Last edited
13/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof John Stein

ORCID ID

Contact details

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

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 measures

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

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

http://www.ox.ac.uk/

Funders

Funder type

Charity

Funder name

Wellcome Trust (grant ref: 078667)

Alternative name(s)

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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