Healthy Clinical Trial
Official title:
Effect of Moderate Alcohol Consumption on Postprandial Insulin Secretion, Appetite Regulation, Glucose Homeostasis and Insulin Resistance.
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.
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.
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
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