Postprandial Insulin Secretion and Appetite Regulation After Moderate Alcohol Consumption
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00524550|
Recruitment Status : Completed
First Posted : September 3, 2007
Last Update Posted : August 12, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Dietary Supplement: moderate alcohol consumption||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Moderate Alcohol Consumption on Postprandial Insulin Secretion, Appetite Regulation, Glucose Homeostasis and Insulin Resistance.|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||November 2007|
Dietary Supplement: moderate alcohol consumption
- Pancreatic beta-cell function [ Time Frame: 3 weeks of treatment preceded by a 1-week wash-out ]
- Satiety [ Time Frame: 3 weeks of treatment preceded by a 1-week wash-out ]
- Kinetics of adiponectin [ Time Frame: 3 weeks of treatment preceded by a 1-week wash-out ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00524550
|TNO Quality of Life|
|Zeist, Utrecht, Netherlands, 3700AJ|
|Principal Investigator:||Henk FJ Hendriks, PhD||Hendriks HFJ|