Postprandial Insulin Secretion and Appetite Regulation After Moderate Alcohol Consumption

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Moderate Alcohol Consumption on Postprandial Insulin Secretion, Appetite Regulation, Glucose Homeostasis and Insulin Resistance.

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: moderate alcohol consumption


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: moderate alcohol consumption|drinking commercially available alcohol-free beer or beer (26 grams of alcohol per day), for three weeks|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kinetics of adiponectin |  | 3 weeks of treatment preceded by a 1-week wash-out | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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