The Impact of Supplementation With Multi-vitamins/Minerals, With and Without Fatty Acids, on Impulsivity and Aggression
NCT ID: NCT01558193
Last Updated: 2017-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
202 participants
INTERVENTIONAL
2011-03-31
2011-07-31
Brief Summary
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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.
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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Placebo
Two placebos consumed
Placebo
Placebo for DHA of identical appearance - based on olive oil
Placebo for vitamins/minerals of identical appearance
Multi-vitamin/mineral
Subjects took multi-vitamin/mineral and placebo fatty acid capsule
Multi-vitamin/mineral
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 acid
Subjects took docosahexaenoic acid capsule and placebo vitamins/minerals
Docosahexaenoic acid
22:6 (n-3) docosahexaenoic each capsule contained 224.2mg and three were taken per day
DHA plus vitamins/minerals
Subjects took both fatty acid and vitamin/mineral supplements
DHA plus vitamins/minerals
The DHA and vitamin/mineral supplements are as above
Interventions
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Placebo
Placebo for DHA of identical appearance - based on olive oil
Placebo for vitamins/minerals of identical appearance
Multi-vitamin/mineral
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 acid
22:6 (n-3) docosahexaenoic each capsule contained 224.2mg and three were taken per day
DHA plus vitamins/minerals
The DHA and vitamin/mineral supplements are as above
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* If they have any history of food intolerance
18 Years
35 Years
MALE
Yes
Sponsors
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Swansea University
OTHER
Responsible Party
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David Benton
Professor of Psychology
Principal Investigators
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David Benton, D.Sc
Role: PRINCIPAL_INVESTIGATOR
Swansea University, Swansea, United Kingdom, SA2 8PP
Locations
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Swansea University
Swansea, Wales, United Kingdom
Countries
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Other Identifiers
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DB-0123-DHAVM
Identifier Type: -
Identifier Source: org_study_id
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