Postprandial Insulin Secretion and Appetite Regulation After Moderate Alcohol Consumption

Sponsor

TNO (Other)

Overall Status

Completed

CT.gov ID

NCT00524550

Collaborator

(none)

Enrollment

Location

Duration (Months)

7.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: moderate alcohol consumption	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Aug 1, 2007

Actual Primary Completion Date :

Nov 1, 2007

Actual Study Completion Date :

Nov 1, 2007

Outcome Measures

Primary Outcome Measures

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

Kinetics of adiponectin [3 weeks of treatment preceded by a 1-week wash-out]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 44 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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