Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201711002748255 Date of Approval: 03/11/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Metabolomics of acute alcohol consumption
Official scientific title A metabolomics investigation on experimental interventions of acute alcohol consumption
Brief summary describing the background and objectives of the trial According to the 2014 World Health Organization global status report on alcohol: ¿Of all deaths worldwide, 5.9% are attributable to alcohol consumption; this is greater than, for example, the proportion of deaths from HIV/AIDS (2.8%), violence (0.9%) or tuberculosis (1.7%)." The main aim of the trial was to determine the effect of acute (a single dose indigested in a short period of time) alcohol consumption, as well as the potential effect of NAD (nicotinamide adenine dinucleotide)as a supplement, on the resulting metabolic profile in a controlled, experimental environment in young, healthy males. The experiment involved 24 participants each undergoing the following interventions: (1) vehicle only ¿ commercial flavoured water containing sodium benzoate as preservative (2) a defined acute dose of alcohol (1.5g per kg body mass), consumed alongside the vehicle (3) an NAD supplement, taken one hour prior to the experiment, followed by consumption of the vehicle (4) the NAD supplement, followed by consumption of the vehicle and the acute alcohol dose.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Acute alcohol abuse
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/02/2013
Actual trial start date 20/04/2013
Anticipated date of last follow up 01/03/2013
Actual Last follow-up date 08/06/2013
Anticipated target sample size (number of participants) 24
Actual target sample size (number of participants) 24
Recruitment status Completed
Publication URL N/A
Secondary Ids Issuing authority/Trial register
NWU-00045-12-S1 Health Sciences Ethical Committee of North-West University
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised All study subjects were numbered sequentially as they were accepted for participation in the study. A random number generator was used to assign participants into the various groups. Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Vehicle 500 mL in 5 minutes 5 hours Vehicle - commercial flavoured water 24
Experimental Group Alcohol 1.5g per kg body mass in 5 minutes 5 hours Alcohol - vodka (43% alcohol) with vehicle 24
Experimental Group nicotinamide adenine dinucleotide (NAD) 50mg in 5 minutes 5 hours NAD - NAD (commercial supplement) with vehicle 24
Experimental Group Alcohol and NAD 1.5g alcohol per kg body mass and 50mg NAD in 5 minutes 5 hours alcohol and NAD with vehicle 24
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Caucasian 2.Male 3.Between the ages of 20 and 30 4.No known medical condition and not on any medication 5.A body mass index of less than 27 6.An MSQ (Medical symptoms questionnaire) score of less than 30 which indicates few/low intensity symptoms 7.A score of less than 8 on the AUDIT alcohol consumption questionnaire. The AUDIT questionnaire is a validated tool to identify people at risk for complications from alcohol consumption. A score of less than 8 is an indication that a person is not at risk. 8.Not enrolled within the Natural Sciences faculty Individuals outside inclusion criteria. 18 Year(s) 24 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/11/2012 Health Sciences Ethical Committee of North-West University
Ethics Committee Address
Street address City Postal code Country
North-West University; Room 135 - 138 Biological Block (Building G16) Potchefstroom Campus North-West University Potchefstroom 2531 Potchefstroom 2521 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary metabolic perturbations caused by intervention 1 hour before intervention at intervention (time 0) 1 hour after intervention 2 hours after intervention 3 hours after intervention 4 hours after intervention
Secondary Outcome Secondary metabolic perturbations caused by intervention 1 hour before intervention at intervention (time 0) 1 hour after intervention 2 hours after intervention 3 hours after intervention 4 hours after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Health Clinic of North-West University (Potchefstroom Campus) Hoffman Street Potchefstroom 2521 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Technology Innovation Agency of South Africa TIA House, 83 Lois Avenue, Menlyn, Pretoria, 0181 Pretoria 0181 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Technology Innovation Agency of South Africa TIA House, 83 Lois Avenue, Menlyn, Pretoria, 0181 Pretoria 0181 South Africa Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Cindy Irwin Centre for Human Metabolomics, Faculty of Natural Sciences and Agriculture, North-West University (Potchefstroom Campus), Private Bag X6001 Potchefstroom 2521 South Africa
Carolus Reinecke Centre for Human Metabolomics, Faculty of Natural Sciences and Agriculture, North-West University (Potchefstroom Campus), Private Bag X6001 Potchefstroom 2521 South Africa
Mari van Reenen Centre for Human Metabolomics, Faculty of Natural Sciences and Agriculture, North-West University (Potchefstroom Campus), Private Bag X6001 Potchefstroom 2521 South Africa
Japie Mienie Centre for Human Metabolomics, Faculty of Natural Sciences and Agriculture, North-West University (Potchefstroom Campus), Private Bag X6001 Potchefstroom 2521 South Africa
Ron Wevers Radboud University Nijmegen Medical Centre, Department of Laboratory Medicine, PO Box 9101, 6500 HB Nijmegen 6500 HB Netherlands
Johan Westerhuis Biosystems Data Analysis, Swammerdam Institute for Life Sciences, University of Amsterdam Amsterdam 1090 GE Netherlands
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Cindy Irwin cindyirwin74@gmail.com +27 833209259 Centre for Human Metabolomics, Faculty of Natural Sciences and Agriculture, North-West University
City Postal code Country Position/Affiliation
Potchefstroom 2521 South Africa PhD student
Role Name Email Phone Street address
Public Enquiries Shayne Mason nmr.nwu@gmail.com +27 0182852531 Centre for Human Metabolomics, Faculty of Natural Sciences and Agriculture, North-West University
City Postal code Country Position/Affiliation
Potchefstroom 2521 South Africa Research scientist
Role Name Email Phone Street address
Scientific Enquiries Shayne Mason nmr.nwu@gmail.com +27 0182852531 Centre for Human Metabolomics, Faculty of Natural Sciences and Agriculture, North-West University
City Postal code Country Position/Affiliation
Potchefstroom 2521 South Africa Research scientist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information