Postprandial Insulin Secretion and Appetite Regulation After Moderate Alcohol Consumption
- Conditions
- Healthy
- Registration Number
- NCT00524550
- Lead Sponsor
- TNO
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 24
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Satiety 3 weeks of treatment preceded by a 1-week wash-out Pancreatic beta-cell function 3 weeks of treatment preceded by a 1-week wash-out
- Secondary Outcome Measures
Name Time Method Kinetics of adiponectin 3 weeks of treatment preceded by a 1-week wash-out
Trial Locations
- Locations (1)
TNO Quality of Life
🇳🇱Zeist, Utrecht, Netherlands