Healthy
Conditions
Keywords
Moderate alcohol consumption, insulin secretion, insulin sensitivity, Beta-cell function, Adiponectin, Appetite, Satiety, Alcohol-induced gene expression, Endocannabinoids, Glucose metabolism, Lipid metabolism, Ratio HMW/total adiponectin, Appetite regulation, Alcohol-induced adiponectin increase
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.
Interventions
DIETARY_SUPPLEMENTmoderate alcohol consumption
drinking commercially available alcohol-free beer or beer (26 grams of alcohol per day), for three weeks
Sponsors
TNO
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 44 Years
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 * Smoking * Reported use of any soft or hard drugs * Reported unexplained weight loss or gain of \> 3 kg in the month prior to the screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pancreatic beta-cell function | 3 weeks of treatment preceded by a 1-week wash-out |
| Satiety | 3 weeks of treatment preceded by a 1-week wash-out |
Secondary
| Measure | Time frame |
|---|---|
| Kinetics of adiponectin | 3 weeks of treatment preceded by a 1-week wash-out |
Countries
Netherlands
Outcome results
None listed