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AggressionNCT01558193

The Impact of Supplementation With Multi-vitamins/Minerals, With and Without Fatty Acids, on Impulsivity and Aggression

A study testing Multi-vitamin/mineral, Docosahexaenoic acid and DHA plus vitamins/minerals in people with Aggression, run by Swansea University at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

There is a series of well designed studies that have reported, in those with a history of anti-social behavior, that supplementation with vitamins / minerals, omega-3 fatty acids (n-3 FA), or both, reduces the incidence of aggressive behavior. Read more about this study

Who is it for?
Ages 18 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for
Aggression
What is being tested?
Multi-vitamin/mineral, Docosahexaenoic acid and DHA plus vitamins/minerals
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
202 participants
Where
1 siteUnited Kingdom
Study dates
Mar 2011to Jul 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Only male participants are being studied of self-reported good health who do not regularly consume seafood. They will be of a minimum age of 18 years of age and a maximum of 35 years of age. They will not be currently taking any medication and have no acute or chronic medical condition

Who cannot join

  • If they had consumed n-3 fatty acid ro vitamin/mineral supplements during the previous six months.
  • If they have any history of food intolerance

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Swansea University

    Swansea, Wales, SA2 8PP

Other trials in United Kingdom

About this study

There is a series of well designed studies that have reported, in those with a history of anti-social behavior, that supplementation with vitamins / minerals, omega-3 fatty acids (n-3 FA), or both, reduces the incidence of aggressive behavior. Although there is evidence that all these nutrients have a role, to date the relative contribution of fatty acids and vitamins / minerals has not been considered: for example the possibility of a synergistic interaction has not yet been examined. In addition the topic has to date been studied under real-life condition, such as a prison, making the topic difficult to study. The major aim of the present study was to develop a paradigm that would allow the study of the topic in a sample from the general population without a history of anti-social behavior. Subjects received either a vitamin/mineral supplement, a fatty acid supplement, both or neither for three months, Measures of impulsivity and aggression were assessed before and after supplementation. Although in the past measures of actual behaviour have proved to be sensitive to supplementation, questionnaire measures have not. The second major objective was therefore to consider whether such phenomena can be studied in a sample without a history of anti-social behavior, using standardized, sensitive laboratory based measures and to compare these with questionnaire measures.

POLYMORPHISMS AND THE RESPONSE TO MICRO-NUTRIENT SUPPLLMENTATION The data set were subsequently used to test an a priori hypothesis not related to the initial hypothesis. A meta-analysis found a consistent pattern that micro-nutrient supplementation improved mood (Long SJ, Benton D. Effects of vitamin and mineral supplementation on stress, mild psychiatric symptoms, and mood in nonclinical samples: a meta-analysis. Psychosom Med 2013; 75: 144-153). To produce evidence of possible mechanisms the extent was determined, to which the impact of micro-nutrient supplementation was influenced by a range of polymorphisms associated with neurotransmitter systems known to modulate mood.

Read more

The primary outcome measure was the General Health Questionnaire, a 30-item self-report questionnaire that was developed to detect, in a community sample, those who would benefit from seeing a psychiatrist.

Given the literature that relates polymorphisms to mood disorders, and the known pharmacology of anti-depressant drugs, a range of polymorphisms were chosen associated with serotonin and catecholamines.

Dopamine The SNPs associated with the metabolism and functioning of dopamine were: Dopamine beta hydroxylase (DBH, rs16111115); Dopamine transporter (DAT1, rs2550946); Catechol-O-methyltransferase (COMT, rs4680, rs6269). Dopamine receptor D1 (DRD1, rs4532); Dopamine receptor D2 (DRD2, rs1079598, rs1800497); Dopamine receptor D3 (DRD3, rs6280); Dopamine receptor D4 (DRD4, rs1800955).

Serotonin Ten SNPs associated with different aspects of serotonin metabolism were also considered. Rs1843809 is a SNP of the TPH2 gene that encodes Tryptophan hydroxylase. Rs1050565 is a SNP in the BLMH gene that influences the activity of 5HTT (SLC6A4), the serotonin transporter. SNPs associated with various serotonin receptors were also examined: genetic variations of the HTR1A gene (5-HT1A receptor, rs6295); HTR1B gene (5-HT1B receptor, rs6296); HTR2A gene (5-HT2A receptor, rs6311); HTR2B gene (5-HT2B receptor, rs1549339); HTR2C gene (5-hydroxytryptamine receptor 2C, rs518147); HTR3A gene (5-hydroxytryptamine receptor 3A, rs1150226); HTR3B (5-HT3B receptor, rs1672717); HTR4 gene (5-HT4 receptor, rs2278392).

Adrenergic mechanisms Finally six SNPs associated with adrenergic receptors were considered: ADRA2A (adrenoceptor alpha 2A, rs553668); ADRB1 (adrenoceptor alpha B1, rs1801253); ADRB2 (adrenoceptor alpha B2, rs1042713; ADRB3 (adrenoceptor alpha B3, rs4994); SLC6AC (noradrenaline transporter, rs5569 and rs2242447).

Analysis The data will be analyzed using analysis of variance with a change in GHQ from before to after supplementation as the dependent variable: Micronutrient/placebo X Polymorphism.

Read the detailed description

Objective: To consider whether aggression and impulsivity respond to multi-vitamins / minerals or fatty acid supplementation and whether there is a synergistic interaction?

In a between subjects design four groups will be contrasted. Those who for three months:

  1. Receive two placebos
  2. Receive multi-vitamin / mineral plus a placebo
  3. Receive fatty acids plus placebo
  4. Receive multi-vitamin / mineral plus fatty acids.
Conditions
Aggression
Being tested
Placebo, Multi-vitamin/mineral, Docosahexaenoic acid, DHA plus vitamins/minerals
Keywords
Aggression DHA, Docosahexaenoic acid, Impulsivity, Minerals, Vitamins
Medical subject headings
Aggression, Impulsive Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDietary supplement

    Also called Does not apply

    Placebo for DHA of identical appearance - based on olive oil

    Placebo for vitamins/minerals of identical appearance

  • Multi-vitamin/mineralDietary supplement

    Also called Centrum Advance 50+ (Pfizer Inc, New York)

    Each active tablet contained vitamins A (800µg); B1 (1.4mg); B2 (1.75mg); B6 (2mg); B12 (2.5mg); biotin 62.5 µg; folic acid 200 µg; niacin 20 mg; C (100mg); D (5µg); E (15mg); K (30µg); pantothenic acid (7.5 mg). In addition several minerals were administered: calcium (162mg); phosphorus (125mg); magnesium (100mg); potassium (40mg); chloride (36.3mg); iron (5mg); iodine (100µg); copper (500µg); manganese (2mg); chromium (40µg); molybdenum (50µg); selenium (30µg); zinc (5mg) as well as lutein (500 µg) . The placebo capsule was identical in color, size and appearance.

  • Docosahexaenoic acidDietary supplement

    Also called Efalex (Efamol Ltd, Leatherhead, England)

    22:6 (n-3) docosahexaenoic each capsule contained 224.2mg and three were taken per day

  • DHA plus vitamins/mineralsDietary supplement

    Also called Efalex (Efamol Ltd), Centrum Advance 50+ (Pfizer Inc, New York)

    The DHA and vitamin/mineral supplements are as above

Study groups in NCT01558193
Study groupRoleWhat they receive
PlaceboPlacebo comparatorTwo placebos consumed
Receives: Dietary Supplement: Placebo
Multi-vitamin/mineralActive comparatorSubjects took multi-vitamin/mineral and placebo fatty acid capsule
Receives: Dietary Supplement: Multi-vitamin/mineral
Docosahexaenoic acidActive comparatorSubjects took docosahexaenoic acid capsule and placebo vitamins/minerals
Receives: Dietary Supplement: Docosahexaenoic acid
DHA plus vitamins/mineralsActive comparatorSubjects took both fatty acid and vitamin/mineral supplements
Receives: Dietary Supplement: DHA plus vitamins/minerals

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Go Stop Impulsivity Paradigm

    The GoStop Impulsivity Paradigm measures the ability to inhibit an already initiated response. A number of five digits are presented on a computer screen for 500ms followed by a 500ms blackout. A second number then appears for 500ms followed by a 500ms blackout. If the numbers are identical the mouse button has to be pressed before the second number disappeared. However, the response has to be with-held if a "Stop" signal appeared; that is the second number was identical but changed from black to red. If the two numbers were different then no response was required.

    Measured: Change from before to after supplementation for three months

  2. Rosenzweig Picture Frustration Test

    This is test of the tendency to respond in an aggressive manner. A series of cartoons are presented that present an intentionally frustrating situation. The participant reports what he or she would say in that situation. Blind the responses are assessed in terms of the extent to which the responses are aggressive in matter

    Note that the use of two primary outcomes reflects the aim of the study to contrast performance and questionnaire measures

    Measured: Change from before to after supplementation for three months

Secondary outcomes (4)
  1. Buss Perry Aggression Scale

    The Buss-Perry Aggression Questionnaire assesses four aspects of aggressive behavior: physical aggression, verbal aggression, anger and hostility. Participants rank statements about their temperament using a 7-point Likert scale ranging from 1 (extremely uncharacteristic of me) to 7 (extremely characteristic of me).

    Measured: Change from before to after supplementation for three months

  2. Perceived Stress Scale

    The Perceived Stress Scale assesses the extent to which stressful thoughts and feeling had been experienced during the last month. For example: "In the last month, how often have you been upset because of something that happened unexpectedly?" The participant responded on a scale ranging from 0 = Never to 4 = Very Often. An overall score is calculated.

    Measured: Change from before to after supplementation for three months

  3. Single Key Impulsivity Paradigm

    A measure of the subjects ability to forgo initial reward for a later larger reward. The subject can choose to wait for a reward and get more points or alternatively respond more quickly and get fewer points sooner. The longer a subject waits the higher the reward; that the more points are earned. A mouse click began the task and a second resulted in a reward. Two counters display the most recent and cumulative reward over a 20 minute session. Subject are able to infer that responses at a faster rate earn smaller rewards.

    Measured: Change from before to after supplementation for three months

  4. General Health Questionnaire

    Polymorphisms associated with the metabolism and receptors of dopamine and serotonin will be related to the response to micro-nutrient supplementation

    Measured: Further analysis of existing data - considers changes from baseline to three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2012 (estimated)
  2. Study startMar 2011
  3. Primary completionJul 2011
  4. Study completionJul 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01558193
Sponsor's protocol ID
DB-0123-DHAVM
Status last verified
May 2017
First submitted
28 Feb 2012
Last updated
5 May 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Multi-vitamin/mineral, Docosahexaenoic acid and DHA plus vitamins/minerals in people with Aggression, run by Swansea University at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Go Stop Impulsivity Paradigm (time frame: Change from before to after supplementation for three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017.

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