Effect of Moderate Alcohol Consumption on Postprandial Insulin Secretion, Appetite Regulation, Glucose Homeostasis and Insulin Resistance.
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- TNO
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Pancreatic beta-cell function
Overview
Brief Summary
A body of epidemiologic studies show that moderate alcohol consumption is associated with a protective effect against type 2 diabetes. The importance of both insulin sensitivity and insulin secretion in the pathogenesis of glucose intolerance and diabetes type 2 is widely recognized. Clinical studies show improved insulin sensitivity after a period of alcohol consumption compared to abstention. However, postprandial insulin secretion and beta-cell function after a period of moderate alcohol consumption have scarcely been addressed in published literature.
When consumed as an aperitif or with a meal, alcohol is generally expected to stimulate appetite and food intake and thus might be a risk factor for over consumption and obesity. However the physiological mechanisms for this observed effect are not well understood. Furthermore, previous studies lacked a link between physiological parameters and subjective parameters of satiety.
Detailed Description
Objective
Primary objectives are to study the effects of moderate alcohol consumption on
- Postprandial insulin secretion and pancreatic beta-cell function
- Physiological and subjective parameters related to satiety and appetite
Secondary objectives are to study the effects of moderate alcohol consumption on
- Miscellaneous markers of glucose homeostasis and insulin sensitivity
- Kinetics of alcohol-induced increase of adiponectin
A tertiary objective is to study the effects of moderate alcohol consumption on
- Gene expression in subcutaneous adipose tissue in normal-weight pre menopausal women with normal fasting plasma glucose.
Study design: Randomized, partially controlled, open label, cross-over study with a one week wash-out preceding each treatment period
Study population: 24 apparently healthy pre menopausal Caucasian women with fasting blood glucose <6.1 mmol/L, aged 20 - 44 years at inclusion of the study, with a BMI of 19 - 25 kg/m2, who use oral contraceptives will participate in the study.
Intervention: Participants will drink daily a test substance for three weeks (2 cans of Amstel beer per day; 66 cL ~ 26 gram alcohol) followed by a reference substance (2 cans of Amstel alcohol-free beer per day; 66 cL < 0.5 gram of alcohol) for three weeks or vice versa. Both treatments are preceded by a one-week wash-out period in which no alcohol is consumed.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 44 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Apparently Females between 20 - 44 years of age
- •Using oral contraceptives for \>3 months (only phase 1 or 2 oral contraceptives)
- •Normal fasting glucose levels as indicated by venous fasting plasma glucose levels \< 6.1 mmol/L
- •Alcohol consumption more or equal then 5 and less than 22 glasses/week
- •Body Mass Index (BMI) between 19 and 25 kg/m2
Exclusion Criteria
- •Having the intention to become pregnant, to be pregnant or to lactate during the study
- •Having a history of medical or surgical events that may significantly affect the study outcome including metabolic or endocrine disease, gastro-intestinal disorder, or eating behavior disorders such as anorexia/bulimia disorders
- •Having a family history of alcoholism
- •Reported use of any soft or hard drugs
- •Reported unexplained weight loss or gain of \> 3 kg in the month prior to the screening
Outcomes
Primary Outcomes
Pancreatic beta-cell function
Time Frame: 3 weeks of treatment preceded by a 1-week wash-out
Satiety
Time Frame: 3 weeks of treatment preceded by a 1-week wash-out
Secondary Outcomes
- Kinetics of adiponectin(3 weeks of treatment preceded by a 1-week wash-out)