Trials / Completed
CompletedNCT00524550
Postprandial Insulin Secretion and Appetite Regulation After Moderate Alcohol Consumption
Effect of Moderate Alcohol Consumption on Postprandial Insulin Secretion, Appetite Regulation, Glucose Homeostasis and Insulin Resistance.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- Sponsor
- TNO · Academic / Other
- Sex
- Female
- Age
- 20 Years – 44 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | moderate alcohol consumption | drinking commercially available alcohol-free beer or beer (26 grams of alcohol per day), for three weeks |
Timeline
- Start date
- 2007-08-01
- Primary completion
- 2007-11-01
- Completion
- 2007-11-01
- First posted
- 2007-09-03
- Last updated
- 2010-08-12
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT00524550. Inclusion in this directory is not an endorsement.