Clinical Trials Directory

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

TypeNameDescription
DIETARY_SUPPLEMENTmoderate alcohol consumptiondrinking 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.