Dry January - Healthy Volunteers 1 month Alcohol Abstention
Research type
Research Study
Full title
Healthy volunteers will abstain from consuming alcohol for one month starting in January with effects on liver fat and metabolic parameters being measured over this period
IRAS ID
167923
Contact name
Liba Stones
Contact email
Sponsor organisation
Royal Free London Foundation NHS trust
Clinicaltrials.gov Identifier
01616257818, 14/NW/1510
Duration of Study in the UK
0 years, 2 months, 1 days
Research summary
We will recruit approximately 120 healthy volunteers who drink greater than 6 units (2 pints of lager) a week and are not alcohol dependent (excluded by use of the validated AUDIT questionnaire) and who are willing to be abstinent from alcohol for four weeks.
At initial assessment physical characteristics – height, weight, blood pressure and percentage body fat. Routine baseline blood tests will be taken to assess liver function, blood sugar and insulin levels, cholesterol, fats and standard biochemistry. Inflammatory cytokines (small proteins released by immune cells that cause inflammation) will also be measured as they have been show to play a key role in the development of liver disease.
A non-invasive Fibroscan (same technology as ultrasound) will assess liver stiffness and fat. This assessment will be repeated after 4 weeks abstinence to assess the impact of abstinence on these physical characteristics. We will also use a questionnaire prior to and after abstinence to assess changes in quality of sleep, wakefulness, concentration and productivity. The same questionnaires will be completed one month after completion of abstinence.
REC name
North West - Preston Research Ethics Committee
REC reference
14/NW/1510
Date of REC Opinion
19 Dec 2014
REC opinion
Favourable Opinion